Latest news with #BIRC
Yahoo
2 days ago
- Business
- Yahoo
The British Medical Journal Publishes Study Results on Sacituzumab Tirumotecan for Previously Treated EGFR-Mutant Advanced NSCLC
CHENGDU, China, June 6, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", today announced that results from its registrational study (OptiTROP-Lung03) evaluating sacituzumab tirumotecan (sac-TMT) versus docetaxel in patients with previously treated advanced EGFR-mutant non-small cell lung cancer (NSCLC) have been published in The British Medical Journal (impact factor: 93.6). These data were also presented as an oral presentation in the Lung Cancer—Non–Small Cell Metastatic session (Abstract #8507) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Based on the encouraging data from this study, sac-TMT was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy in March 2025. This marks the first global approval of a TROP2 ADC for a lung cancer indication. The published results are based on OptiTROP-Lung03, an open-label, randomized, multicenter registrational study evaluating the efficacy and safety profile of sac-TMT monotherapy versus docetaxel for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC who have failed after treatment with an EGFR-TKI and platinum-based chemotherapy. A total of 137 patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-TKI and platinum-based chemotherapy were randomized (2:1) to receive sac-TMT (5 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until disease progression, intolerable toxicity or other reason for discontinuation, with a median follow-up time of 12.2 months (Data cutoff date: December 31, 2024). Sac-TMT achieved statistically significant and clinically meaningful outcomes compared to docetaxel: Confirmed objective response rate (ORR) (As assessed by blinded independent review committee (BIRC): 45% (95% CI, 35-56) vs 16% (95% CI, 7-30). Median progression-free survival (PFS) (As assessed by BIRC: 6.9 months [sac-TMT; 95% CI, 5.4-8.2] vs 2.8 months [docetaxel; 95% CI, 1.6-4.1], hazard ratio (HR)= 0.30 [range, 0.20 -0.46], one-sided p<0.0001; as assessed by investigator (INV): 7.9 months [sac-TMT; 95% CI, 6.2-9.5] vs 2.8 months [docetaxel; 95% CI, 1.5-3.8], HR=0.23 [95% CI, 0.15-0.36], one-sided p<0.0001). With 36.4% of patients in docetaxel group crossing over to receive sac-TMT, median overall survival (OS) was not reached (NR) for both groups (HR=0.49; 95% CI, 0.27-0.88; one-sided p=0.007). The median OS analysed by pre-specified rank-preserving structural failure time (RPSFT) model adjusted for crossover was 9.3 months for docetaxel and NR for sac-TMT (HR=0.36; 95% CI, 0.20-0.66). Efficacy benefit favored patients with sac-TMT over docetaxel across all pre-specified subgroups, including prior EGFR-TKI therapy, brain metastases, EGFR mutation type, etc. Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 56.0% of patients in sac-TMT group vs 71.7% in docetaxel group. The results demonstrated that sac-TMT monotherapy achieved statistically significant and clinically meaningful improvements in objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to docetaxel, with a manageable safety profile. Sac-TMT is being extensively studied in the NSCLC field. Covering treatment settings from later-line therapy to early-stage postoperative adjuvant therapy, including both monotherapy and combination regimens. Currently, five company-led registrational clinical studies for sac-TMT in NSCLC are underway in China. Meanwhile, Merck Sharp & Dohme（the tradename of Merck & Co., Inc., Rahway, NJ, USA）is also conducting five global Phase III clinical trials of sac-TMT for NSCLC in regions where it has exclusive rights. Professor Li Zhang, National Lead Principal Investigator, Medical Oncologist and Deputy Director of the Lung Cancer Research Centre at Sun Yat-Sen University, stated: "EGFR mutation is the most common driver alteration in NSCLC. The prevalence of EGFR mutations reaches 28.2% among NSCLC patients in China. Although third-generation EGFR-TKIs have become the standard of care for advanced EGFR-mutant NSCLC and may significantly improve PFS, acquired resistance remains inevitable. Combining EGFR-TKIs with chemotherapy can offer additional survival benefits to some patients, but this approach is limited by safety concerns and may compromise future treatment options, posing significant clinical challenges. The publication of the OptiTROP-Lung03 study in the British Medical Journal marks a major milestone—not only highlighting international recognition of this study outcomes in lung cancer, but also demonstrating the global competitiveness of sac-TMT as a novel TROP2 ADC." Dr. Michael Ge, CEO of Kelun-Biotech, commented: "We are thrilled to see the OptiTROP-Lung03 study published in a top-tier journal. Currently, EGFR-TKIs and chemotherapy remain the standard of care for patients with EGFR-mutant advanced NSCLC, but the challenge of increasing efficacy with manageable tolerability. The results from OptiTROP-Lung03 highlight significant survival benefits with manageable safety profile and suggest that sac-TMT could emerge as a new standard of care for this population. We remain committed to working with our partners to establish sac-TMT as a new standard of care for this patient population and improve outcomes for lung cancer patients worldwide." Registrational Study Led by Kelun-Biotech OptiTROP-Lung03: Sac-TMT monotherapy versus docetaxel for locally advanced or metastatic EGFR-mutant NSCLC after treatment failure with EGFR-TKI and platinum-containing chemotherapy； OptiTROP-Lung04: Sac-TMT monotherapy versus pemetrexed in combination with platinum for locally advanced or metastatic non-squamous NSCLC with EGFR mutations that have failed EGFR-TKI therapy； OptiTROP-Lung05: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC; OptiTROP-Lung06: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for the first-line treatment of PD-L1-negative locally advanced or metastatic non-squamous NSCLC; OptiTROP-Lung07: First-line treatment of locally advanced or metastatic NSCLC with EGFR mutations by sac-TMT in combination with ositinib. Registrational Study Led by MSD NSCLC not achieving a pCR after neoadjuvant therapy followed by surgery. NSCLC expressing PD-L1 >50% pre-treated NSCLC with EGFR mutations or other genomic alterations EGFR-mutated, advanced non-squ NSCLC progressed on prior EGFR-TK metastatic sg NSCLC About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) based on the OptiTROP-Breast01 study and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy based on the OptiTROP-Lung03 study. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the National Medical Products Administration (NMPA), and were reviewed via the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. About Kelun-Biotech Kelun-Biotech（ a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel coupled drug products in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@ View original content to download multimedia: SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Yahoo
5 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Upturn
28-05-2025
- Business
- Business Upturn
Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor
Darmstadt, Germany: Global Phase 3 MANEUVER study of pimicotinib in tenosynovial giant cell tumor (TGCT) met the primary endpoint, demonstrating objective response rate at week 25 of 54.0% versus 3.2% for placebo (p<0.0001) MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume Treatment was well-tolerated, with low incidence of treatment discontinuation and dose reductions Not intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced the presentation of detailed positive results from Part 1 of the global Phase 3 MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., in the treatment of patients with tenosynovial giant cell tumor (TGCT). Once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo (p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT. These findings will be presented Sunday, June 1 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #11500). 'The impact that TGCT has on patients goes far beyond the physical presence of the tumor. It affects their ability to work, to move freely, and to engage in everyday activities,' said Prof. Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. 'In MANEUVER, we observed the highest ORR seen to date with a systemic therapy, together with statistically significant improvements in measures of pain, stiffness, and range of motion. These improvements in outcomes that matter to patients with TGCT and the physicians who care for them show the potential of pimicotinib to allow patients to go about their daily lives with fewer negative effects of their disease.' In MANEUVER, which enrolled patients from China, Europe and North America, the effect of pimicotinib had an early onset, with 41.3 % (26 of 63) of patients experiencing objective response to therapy after 13 weeks. By the data cutoff for primary analysis, nearly all patients in the pimicotinib group (58 of 63 patients; 92.1%) had a decrease in tumor size per BIRC based on RECIST v1.1; one patient achieved a complete response and 33 patients achieved a partial response. The median duration of response was not reached by the data cutoff. The analysis of tumor volume score (TVS, an endpoint designed specifically for TGCT) showed that nearly two-thirds of patients treated with pimicotinib experienced a reduction in tumor volume of at least 50% (61.9% vs. 3.2% for placebo, p<0.0001). Pimicotinib also demonstrated statistically significant and clinically meaningful improvement across all additional secondary endpoints relevant to patients' daily lives, and these improvements were seen regardless of achieving objective tumor response to pimicotinib. Pimicotinib improved active range of motion (p=0.0003) and physical function measured by PROMIS-PF scale (p=0.0074). Pimicotinib also reduced worst stiffness (p<0.0001) and worst pain (p<0.0001). 'TGCT, although rare, has a significant impact on the daily lives of the primarily working-age adults who live with the disease, due to swelling, pain, stiffness, and limited mobility caused by the growth of these tumors in and around the joints,' said Danny Bar-Zohar, appointed CEO Healthcare and current Global Head of R&D and Chief Medical Officer. 'The landmark global Phase 3 MANEUVER study data will help redefine how TGCT is treated, and we plan regulatory submissions to start this year.' Pimicotinib was well-tolerated, and the safety profile was consistent with previously reported data, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients. About MANEUVER The pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21). In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population. Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS). After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up. About Pimicotinib (ABSK021) Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy. Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of unresectable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib. Advancing the Future of Cancer Care At Merck, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer's deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors. Learn more at About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck, generated sales of € 21.2 billion in 65 countries. The company holds the global rights to the name and trademark 'Merck' internationally. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to to register for your online, change your selection or discontinue this service. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
Malaysian Reserve
23-05-2025
- Business
- Malaysian Reserve
Six Abstracts of Kelun-Biotech's Clinical Studies Published at the 2025 ASCO Annual Meeting
CHENGDU, China, May 23, 2025 /PRNewswire/ — The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is scheduled to take place in Chicago, Illinois, USA from May 30 to June 3. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ( the 'Company') will present results from six clinical studies, including data on its TROP2 ADC sac-TMT, anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031) during the meeting. The study abstracts were published on the ASCO website on May 22, 2025 (CDT), with key highlights summarized below: 1. Sac-TMT in patients with previously treated advanced epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study Oral Presentation: June 1, 10:12-10:24 CDT (Abstract #8507: Lung Cancer – Non-Small Cell Metastatic) A total of 137 patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy were randomized (2:1) to receive sac-TMT (5 mg/kg once every 2 weeks (Q2W)) or docetaxel (75 mg/m2 once every 3 weeks (Q3W)). The median follow-up of 12.2 months (data cutoff: December 31, 2024). Sac-TMT achieved statistically significant and clinically meaningful outcomes compare d to docetaxel: confirmed objective response rate (ORR) (blinded independent review committee (BIRC): 45.1% vs 15.6%, one-sided p=0.0004), progression-free survival (PFS) (BIRC: median 6.9 vs 2.8 months, hazard ratio (HR)= 0.30, one-sided p<0.0001; investigator (INV): median 7.9 vs 2.8 months, HR=0.23). With 36.4% of patients in docetaxel group crossing over to receive sac-TMT, median overall survival (OS) was not reached (NR) for both groups (HR 0.49, one-sided p=0.007). The median OS analysed by pre-specified rank-preserving structural failure time (RPSFT) model adjusted for crossover was 9.3 months for docetaxel and NR for sac-TMT (HR=0.36). Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 56.0% of patients in sac-TMT group vs 71.7% in docetaxel group. No cases of interstitial lung disease (ILD) were reported in sac-TMT group. These results led to the approval of sac-TMT in EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy in China, which marks the first approval for a TROP2 ADC in lung cancer globally. 2. Sac-TMT as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase 2 OptiTROP-Breast05 study Rapid Oral Presentation: May 30, 15:45-15:51 CDT (Abstract #1019: Breast Cancer – Metastatic) As of November 18, 2024, a total of 41 patients with a/m TNBC who had not received prior treatment for advanced disease (median age 55 years; 43.9% Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 1; 78.0% PD-L1 combined positive score (CPS)<10) were enrolled to receive sac-TMT monotherapy at 5 mg/kg Q2W until disease progression or unacceptable toxicity. The median follow-up was 18.6 months. The ORR was 70.7% and the disease control rate (DCR) was 92.7%. Median duration of response (DoR) was 12.2 months, while the median PFS was 13.4 months. Among the 32 patients with PD-L1 CPS <10, the ORR was 71.9% and the DCR was 93.8%. The median PFS in this subgroup was 13.1 months. TRAEs of grade 3 or higher occurred in 63.4% of patients. No treatment-related deaths occurred, and there were no reports of neuropathy or ILD/pneumonitis. 3. Sac-TMT in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced NSCLC: Non-squamous cohort from the Phase 2 OptiTROP-Lung01 study Poster Presentation: May 31, 13:30-16:30 CDT (Abstract #8529: Lung Cancer – Non-Small Cell Metastatic) Advanced NSCLC patients with no prior systemic therapy and no actionable genomic alterations were enrolled to receive sac-TMT (5 mg/kg Q3W or Q2W) plus tagitanlimab (1,200 mg Q3W or 900 mg Q2W) until disease progression or unacceptable toxicity. As of December 30, 2024, 81 patients with non-squamous histology were enrolled. After median follow-up of 17.1 months, confirmed ORR was 59.3%; Median DoR was 16.5 months; Median PFS was 15.0 months. Among patients with PD-L1 tumor proportion score (TPS)≥50%, the confirmed ORR was 77.8%; median PFS was 17.8 months; while for patients with PD-L1 TPS≥1%, the confirmed ORR was 68.1%; median PFS was 17.8 months. Among patients with PD-L1 TPS< 1%, confirmed ORR was 47.1%; median PFS was 12.4 months. Most common Grade≥3 TRAEs were neutrophil count decreased (45.7%), anemia (16.0%), white blood cell count decreased (14.8%) and stomatitis (11.1%). No TRAE led to treatment discontinuation or death. 4. Sac-TMT in patients with previously treated locally advanced or metastatic (LA/M) NSCLC harboring uncommon EGFR mutations: Preliminary results from a Phase 2 Study Poster Presentation: May 31, 13:30-16:30 CDT (Abstract #8615: Lung Cancer – Non-Small Cell Metastatic) As of December 1, 2024, 42 advanced NSCLC patients who had progressed on or after systemic therapy were enrolled, including 23 patients with EGFR G719X in exon 18, S768I in exon 20, or L861Q in exon 21 and 19 patients with EGFR ex20ins. Patients received sac-TMT 5 mg/kg Q2W until disease progression or unacceptable toxicity. After a median follow-up of 9.2 months, the ORR was 35.7% and the DCR was 85.7%. Responses were durable with the median DoR not yet reached. The median PFS was 9.5 months. In the subset of patients with uncommon non-ex20ins, the ORR was 34.8%; the median PFS was 10.9 months. In the subset of patients with ex20ins, the ORR was 36.8% and the median PFS was 9.0 months. Grade ≥3 TRAEs occurred in 52.4% of patients. No TRAEs led to treatment discontinuation or death. No cases of ILD/pneumonitis were reported. 5. Tagitanlimab versus placebo in combination with gemcitabine and cisplatin (GP) as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase Phase 3 study Oral Presentation: May 31, 14:27-14:39 CDT (Abstract #6004: Head and Neck Cancer). Eligible R/M NPC patients who have not previously received systemic therapy were in 2:1 ratio randomly assigned to receive tagitanlimab or placebo (1200 mg, D1) in combination with cisplatin (80 mg/m2, D1) and gemcitabine (1000 mg/m2, D1 and D8) Q3W for up to 6 cycles followed by tagitanlimab or placebo monotherapy Q3W until disease progression, unacceptable toxicity, or withdrawal of consent. The median follow-up time was 11.7 months. The PFS per blinded independent central review (BICR) was met with a 53% reduction in risk of progression or death (HR=0.47, one-sided P <0.0001). The median PFS was not reached in tagitanlimab plus GP arm and 7.9 months in placebo plus GP arm. The ORR per BICR was 81.7% in tagitanlimab plus GP arm and 74.5% in placebo plus GP arm, with a median DoR of 11.7 months and 5.8 months (HR=0.48), respectively. The OS benefit was observed in tagitanlimab plus GP arm vs placebo plus GP arm (median OS not reached for either arm; HR=0.62). Tagitanlimab also showed a manageable safety profile. 6. Results from a Phase 1 study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer (MTC) Poster Presentation: June 2, 9:00-12:00 CDT (Abstract #6098: Head and Neck Cancer) As of September 20, 2024, 27 advanced RET-mutant MTC patients without prior selective RET inhibitors were enrolled and treated in the phase 1 part across 4 dose levels (20 to 90 mg once a day (QD)). The median follow-up was 19.0 months. As of September 20, 2024, the confirmed ORR was 63.0% and the DCR was 100% for overall population. The confirmed ORR was 56.3% (9/16) and 62.5% (5/8) in patients with prior multikinase inhibitor (MKI) or treatment naïve, respectively. Median DoR was not reached, with the longest duration still ongoing at 25.8 months. Similarly, median PFS was not reached, with the 24-month PFS rate of 77.8%. All patients experienced TRAEs, with grade ≥3 TRAEs occurred in 22.2% of patients. No TRAEs led to treatment discontinuation or death. About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestically developed and fully approved for marketing ADC in China with global intellectual property rights. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the National Medical Products Administration (NMPA), and were (to be) reviewed via the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab Tagitanlimab is the first PD-L1 mAb to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About KL590586 (A400/EP0031) KL590586(A400/EP0031) is a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. The Company are currently conducting pivotal clinical studies for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China. In March 2021, The Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031. In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the Food and Drug Administration (FDA) for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE. About Kelun-Biotech Kelun-Biotech（ a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@ [1] Pembrolizumab (KEYTRUDA®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
