Latest news with #HER2-positive
Yahoo
2 days ago
- Business
- Yahoo
Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors
Phase 11 First-In-Human study designed to assess safety, tolerability, right dose for Phase 2 and early signs of efficacy of 177Lu-RAD202 in individuals with advanced HER2-positive solid tumors Previous clinical proof-of concept data2 for targeting HER-2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans SYDNEY, June 04, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its Phase 1 'HEAT' clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors. The open-label Phase 1 'HEAT' clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia. 'Dosing patients in the HEAT clinical trial marks an important milestone in our transition to a clinical-stage company,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. 'Despite progressive improvements in the management of metastatic HER2-positive disease, the majority of patients experience disease progression on current standard of care and require further therapeutic options. The dosing of the first patient in the 'HEAT' trial represents a significant step toward achieving RAD202's potential to address an unmet need for HER2-positive metastatic patients who are progressing or unable to tolerate current treatment options. With RAD202, we hope to provide an option that can meaningfully improve clinical outcomes for HER2-positive patients, while preserving their quality of life.' HER2 is overexpressed in breast cancer as well as several other solid tumors and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study of RAD202 demonstrated clinical proof-of concept as well as the safety and biodistribution of RAD202, validating its potential for the treatment of advanced HER2-expressing cancers2. Preclinical findings3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify first in humans dose finding studies. 'It is a privilege to be the first centre to administer 177Lu-RAD202, targeting HER2-positive tumors in this Phase 1 clinical trial (HEAT).' said Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at St John of God Murdoch Hospital. 'This opens the possibility of novel therapeutic avenues for patients with aggressive tumor types, including breast, ovarian, gastric, pancreatic, bladder, and several other cancers. With the trust put in us by Radiopharm, we look forward to a successful trial with beneficial outcomes for our patients.' About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper. For more information: Riccardo Canevari CEO & Managing Director P: +1 862 309 0293 E: rc@ Anne Marie FieldsPrecision AQ (Formerly Stern IR)E: Paul Hopper Executive Chairman P: +61 406 671 515 E: paulhopper@ MediaMatt Wright NWR Communications P: +61 451 896 420 E: matt@ ________________________________ 1 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-36223 Altunay B. et al, EP-0136, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026. DOI: 10.1007/s00259-024-06838-zSign in to access your portfolio
Daily Tribune
2 days ago
- Business
- Daily Tribune
New hope for patients with less common breast cancer
A new treatment nearly halves the risk of disease progression or death from a less common form of breast cancer that hasn't seen major drug advances in over a decade, researchers reported Monday. Results from the study, presented at the annual meeting of the American Society for Clinical Oncology, are expected to be submitted to regulators and could soon establish a new firstline therapy for people with HER2-positive metastatic breast cancer -- the advanced stage of a form that comprises 15–20% of all breast cancer cases. HER2-positive cancers are fueled by an overactive HER2 gene, which makes too much of a protein called human epidermal growth factor receptor 2 that helps cancer cells grow and spread. Patients with HER2-positive breast cancer that has spread to other parts of the body live around five years. 'Seeing such a striking improvement was really impressive to us -- we were taking a standard and almost doubling how long patients could have their cancer controlled for,' oncologist Sara Tolaney, chief of the breast oncology division at Dana-Farber Cancer Institute, told AFP. The current standard of care, known as THP, combines chemotherapy with two antibodies that block growth signals from the HER2 protein. The new approach uses a drug called trastuzumab deruxtecan (T-DXd), an antibody attached to a chemotherapy drug. 'Smart bomb' This 'smart bomb' strategy allows the drug to target cancer cells directly. 'You can bind to the cancer cell and dump all that chemo right into the cancer cells,' explained Tolaney. 'Some people call them smart bombs because they're delivering chemo in a targeted fashion -- which is how I think we're able to really increase efficacy so much.' Common side effects included nausea, diarrhea and a low white blood cell count, with a less common effect involving lung scarring. T-DXd is already approved as a 'second-line' option -- used when first-line treatments stop working. But in the new trial, it was given earlier, paired with another antibody, pertuzumab. In a global trial led by Tolaney, just under 400 patients were randomly assigned to receive T-DXd in combination with pertuzumab, thought to enhance its effects. A similar number received the standard THP regimen. A third group, who received T-DXd without pertuzumab, was also enrolled -- but those results haven't yet been reported. 44 percent risk reduction At a follow-up of 2.5 years, the T-DXd and pertuzumab combination reduced the risk of disease progression or death by 44% compared to standard care. Fifteen percent of patients in the T-DXd group saw their cancer disappear entirely, compared to 8.5% in the THP group. Because this was an interim analysis, the median progression-free survival -- meaning the point at which half the patients had seen their cancer return or worsen -- was 40.7 months with the new treatment, compared to 26.9 months with the standard, and could rise further as more data come in. Tolaney said the results would be submitted to regulators around the world, including the US Food and Drug Administration, and that future work would focus on optimizing how long patients remain on the treatment, particularly those showing complete remission. 'This represents a new firstline standard treatment option for HER2-positive metastatic breast cancer,' said Dr. Rebecca Dent, a breast cancer specialist at the National Cancer Center Singapore who was not involved in the study.
Yahoo
3 days ago
- Business
- Yahoo
Alphamab Oncology Presented Multiple Clinical Data of Anti-HER2 Biparatopic ADC JSKN003 at the 2025 ASCO Annual Meeting
SUZHOU, China, June 3, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: announced that multiple clinical data updates for anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 were presented as posters at the 2025 Annual Meeting of American Society of Clinical Oncology (2025 ASCO Annual Meeting) from May 30 to June 3, 2025, in Chicago, IL, U.S.. The results covered platinum-resistant ovarian cancer, HER2-positive breast cancer, and HER2-overexpressing gastrointestinal tumors. Title: JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trialsAbstract Number for Publication: 5557Session Type and Title: Poster Session - Gynecologic CancerSession Date and Time: 6/1/2025 9:00 AM-12:00 PM CDTPresenter: Xiaohua Wu, Fudan University Shanghai Cancer Center Methods JSKN003-101 (NCT05494918) is a Phase I study in Australia and JSKN003-102 (NCT05744427) is a Phase I/II study in China. Both trials enrolled patients with advanced solid tumors who were to receive JSKN003 monotherapy at various dose levels. Pooled results have demonstrated that JSKN003 monotherapy has promising efficacy signals in patients with PROC, and the efficacy was observed across patients with (IHC 1+/2+/3+) or without (IHC 0) HER2 expression, with or without prior bevacizumab and prior PARP inhibitor. Preliminary data from the pooled analysis of these two studies were presented at the 2024 European Society for Medical Oncology (ESMO) Congress for the first time. The latest findings for non-primary platinum-refractory PROC patients at a longer follow-up time were reported at this ASCO Annual Meeting. Results As of February 28, 2025, 46 PROC patients were enrolled and received JSKN003 every three weeks across five doses levels, among which 2 patients at the dose of 4.2 mg/kg, 2 patients at the dose of 5.2 mg/kg, 40 patients at the dose of 6.3 mg/kg (RP2D), 1 patient at the dose of 7.3mg/kg, and 1 patient at the dose of 8.4mg/kg. Efficacy: With a median follow-up time of 9.3 months, 46 patients were efficacy evaluable. 42 patients (91.3%) exhibited tumor shrinkage. The objective response rate (ORR) was 63.0%, the median progression-free survival (PFS) was 7.7 months, and the 9-month overall survival (OS) rate was 89.9%. Efficacy was observed across different HER2-expression subgroups. The ORR was 52.4% and the median PFS was 6.6 months in patients with HER2 IHC 0. The ORR reached 72.2% and the median PFS was 9.4 months in patients with HER2 expression (IHC 1+/2+/3+). Safety: Grade 3-4 treatment-related adverse events (TRAEs) occurred in 9 patients (19.6%). Serious TRAEs were reported in 6 patients (13.0%). No TRAEs leading to death. Interstitial lung disease (ILD) was observed in 5 patients (10.9%), all were Grade 1/2. Conclusions With extended follow-up, JSKN003 demonstrated robust PFS improvement in PROC, along with early signals of OS benefit. A confirmatory trial (JSKN003-306, NCT06751485) is currently enrolling all comers regardless of HER2 expression to validate JSKN003 as a treatment option for this patient population. Title: JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studiesAbstract Number for Publication: 1028Session Type and Title: Poster Session - Breast Cancer - MetastaticSession Date and Time: 6/2/2025 9:00 AM-12:00 PM CDTPresenter: Yiqun Du, Fudan University Shanghai Cancer Center Methods The pooled analysis was performed to evaluate the efficacy and safety of JSKN003 in HER2-positive (IHC 3+ or 2+/ISH+) advanced breast cancer from the Phase I clinical trial (JSKN003-101, NCT05494918) in Australia and the Phase I/II clinical trial (JSKN003-102, NCT05744427) in China. Results As of February 28, 2025, the median follow-up duration was 6.1 months. A total of 88 patients with HER2-positive breast cancer were enrolled, with the majority receiving 6.3 mg/kg or 8.4 mg/kg doses. The median age was 55 years (range: 32-79), with 77.3% ECOG PS 1. All patients had stage IV disease, with 76.1% having visceral metastases. All patients had prior anti-HER2 therapy, including 85.2% with prior ADCs or TKIs, and 55.7% having at least three prior lines treatment. Efficacy: A total of 80 T-DXd-naïve patients were enrolled, of whom 75 were evaluable for efficacy. In this population (N=75), JSKN003 demonstrated a confirmed ORR of 54.7% (95% CI: 42.7-66.2). The disease control rate (DCR) and clinical benefit rate (CBR) were 94.7% and 66.7%, respectively. Among 30 patients treated at the RP2D of 6.3 mg/kg, the confirmed ORR was 73.3%, and CBR reached 83.3%. Subgroup analyses by line of therapy showed ORRs of 66.7% in the prior first line group of 15 patients and 63.2% in the prior second line group of 19 patients, respectively. In addition, 8 patients who had previously received T-DXd were enrolled, among whom 7 had evaluable efficacy data. One patient achieved a partial response (PR), four had stable disease (SD), and tumor shrinkage was observed in four patients. These patients were analyzed separately for exploratory purposes. The median duration of response (DoR) in the overall population was 18.4 months (95% CI: 9.9-NE). Median PFS was not mature at the time of data cutoff. The 3-month and 6-month PFS rates were 88.4% (95% CI: 78.8–93.8) and 75.4% (95% CI: 62.3–84.4), respectively. Safety: 15.9% of patients experienced Grade 3 or higher TRAEs. Serious TRAEs were reported in 5.7% of patients. Dose reductions due to TRAEs occurred in 12.5% of patients, and one patient discontinued due to a TRAE. No TRAEs led to death. The most common TRAEs (≥20%) were nausea, increased alanine aminotransferase, decreased white blood cell count, vomiting, anemia, decreased appetite, thrombocytopenia, fatigue, neutropenia, and diarrhea. ILD was reported in 4 patients (4.5%), mostly Grade 1-2; one case was Grade 3. Conclusions JSKN003 demonstrated promising antitumor activity and manageable safety in heavily pretreated HER2-positive breast cancer, including patients previously treated with T-DXd. Its biparatopic HER2 antibody design may enhance target binding and contribute to the observed clinical benefit. A pivotal Phase III trial (JSKN003-301, NCT06846437) is ongoing to compare JSKN003 with T-DM1 in patients with HER2-positive advanced breast cancer who were previously treated with trastuzumab. Title: A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumorsAbstract Number for Publication: 3022Session Type and Title: Poster Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor BiologySession Date and Time: 6/2/2025 1:30 PM-4:30 PM CDTPresenter: Dan Liu, Beijing Cancer Hospital Methods The pooled analysis was performed to evaluate the efficacy and safety of JSKN003 in HER2-overexpressing (IHC 3+) metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJC) and colorectal cancer (CRC) patients from the Phase I clinical trial (JSKN003-101, NCT05494918) in Australia and the Phase I/II clinical trial (JSKN003-102, NCT05744427) in China. Results As of February 28, 2025, a total of 50 patients with HER2-overexpressing gastrointestinal tumors (27 patients in GC/GEJC and 23 patients in CRC) were enrolled and treated with JSKN003 monotherapy across 7 dose levels: 1 patient at the dose of 2.1 mg/kg, 1 patient at the dose of 4.2 mg/kg, 1 patient at the dose of 5.2 mg/kg, 43 patients at the dose of 6.3 mg/kg, 1 patient at the dose of 7.3 mg/kg, 2 patients at the dose of 8.4 mg/kg and 1 patient at the dose of 10.5 mg/kg. The median age was 60 years (range: 52-66), with 86.0% ECOG PS 1. Most patients were heavily pretreated: 38.0% had at least three lines of prior therapies, 68.0% received anti-HER2 therapy, 48.0% received Irinotecan. Efficacy: Among 48 patients who had at least one tumor assessment after baseline, JSKN003 demonstrated the ORR of 62.5% and the DCR was 93.8%. Among 27 patients with GC/GEJC, the ORR was 63.0% and DCR reached 92.6%. Among 21 patients with CRC, the ORR was 61.9% and DCR reached 95.2%. Among twenty patients with BRAF V600E-wild type, the ORR was 65.0%. Additionally, among 24 patients (4 patients in GC/GEJC and 20 patients in CRC) who were pretreated with irinotecan, the ORR achieved 58.3%. The median DoR in GC/GEJC patients was 9.6 months (95% CI: 3.0-NE), while the median DoR in CRC patients was 12.1 months (95% CI: 5.8-NE). Median PFS was 9.6 months (95%CI: 4.3, 11.6) with 70.4% PFS rate at 6 months in GC/GEJC patients. Median PFS was 13.8 months (95% CI: 6.8, NE) with 88.9% PFS rate at 6 months in CRC patients. Safety: 18.0% of patients experienced Grade 3 or higher TRAEs. Serious TRAEs were reported in 6.0% of patients. Dose reduction due to TRAEs occurred in 20.0% of patients and 16.3% at RP2D. No TEAEs led to discontinuation or death. The most common TRAEs (≥20%) were nausea, diarrhea, decreased appetite, decreased white blood cell count, anemia, fatigue, decreased neutrophil count, decreased platelet count and vomiting. ILD was reported in 3 patients (6.0%), with Grade 1 in 2 patients and Grade 2 in 1 patient. Conclusions JSKN003 demonstrated promising efficacy in heavily pretreated HER2-overexpressing (IHC3+) gastrointestinal tumors including patients previously treated with irinotecan, with a manageable and predictable safety profile. The HER2 biparatopic ADC design may contribute to the observed clinical benefit. About JSKN003 JSKN003 is a bispecific ADC developed based on KN026 using Alphamab's proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing breast cancer (BC), or high HER2-expressing solid tumors. JSKN003 was granted breakthrough therapy designation by CDE. The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing BC, PROC, and HER2-positive BC as well as multiple exploratory Phase II clinical studies are currently undergoing smoothly. In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003. About Alphamab Oncology Alphamab Oncology is an innovative biopharmaceutical company focusing on oncology therapeutics. By leveraging its proprietary core technology platforms including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload antibody conjugation, and subcutaneous high concentration formulation for biologics, the Company has established a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge areas such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies. The Company has one product approved for marketing (Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor), which has made a significant breakthrough in the convenience and accessibility of cancer treatment. Additionally, the Company has multiple bispecific antibodies and bispecific ADCs in clinical stage, while rapidly advancing the preclinical pipeline prioritizing bispecific ADCs and dual-payload ADCs. Multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as CSPC, ArriVent, and Glenmark. Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide. View original content: SOURCE Alphamab Oncology Sign in to access your portfolio
New Straits Times
3 days ago
- Health
- New Straits Times
New hope for patients with less common breast cancer
WASHINGTON: A new treatment nearly halves the risk of disease progression or death from a less common form of breast cancer that hasn't seen major drug advances in over a decade, researchers reported Monday. Results from the study, presented at the annual meeting of the American Society for Clinical Oncology, are expected to be submitted to regulators and could soon establish a new first-line therapy for people with HER2-positive metastatic breast cancer – the advanced stage of a form that comprises 15–20 per cent of all breast cancer cases. HER2-positive cancers are fuelled by an overactive HER2 gene, which makes too much of a protein called human epidermal growth factor receptor 2 that helps cancer cells grow and spread. Patients with HER2-positive breast cancer that has spread to other parts of the body live around five years. "Seeing such a striking improvement was really impressive to us – we were taking a standard and almost doubling how long patients could have their cancer controlled for," said oncologist Sara Tolaney, chief of the breast oncology division at Dana-Farber Cancer Institute, speaking to AFP. The current standard of care, known as THP, combines chemotherapy with two antibodies that block growth signals from the HER2 protein. The new approach uses a drug called trastuzumab deruxtecan (T-DXd), an antibody attached to a chemotherapy drug. This "smart bomb" strategy allows the drug to target cancer cells directly. "You can bind to the cancer cell and dump all that chemo right into the cancer cells," explained Tolaney. "Some people call them smart bombs because they're delivering chemo in a targeted fashion – which is how I think we're able to really increase efficacy so much." Common side effects included nausea, diarrhoea and a low white blood cell count, with a less common effect involving lung scarring. T-DXd is already approved as a "second-line" option – used when first-line treatments stop working. But in the new trial, it was given earlier, paired with another antibody, pertuzumab. In a global trial led by Tolaney, just under 400 patients were randomly assigned to receive T-DXd in combination with pertuzumab, thought to enhance its effects. A similar number received the standard THP regimen. A third group, who received T-DXd without pertuzumab, was also enrolled – but those results haven't yet been reported. At a follow-up of 2.5 years, the T-DXd and pertuzumab combination reduced the risk of disease progression or death by 44 per cent compared to standard care. Fifteen per cent of patients in the T-DXd group saw their cancer disappear entirely, compared to 8.5 per cent in the THP group. Because this was an interim analysis, the median progression-free survival – meaning the point at which half the patients had seen their cancer return or worsen – was 40.7 months with the new treatment, compared to 26.9 months with the standard, and could rise further as more data come in. Tolaney said the results would be submitted to regulators around the world, including the US Food and Drug Administration, and that future work would focus on optimising how long patients remain on the treatment, particularly those showing complete remission. "This represents a new first-line standard treatment option for HER2-positive metastatic breast cancer," said Dr Rebecca Dent, a breast cancer specialist at the National Cancer Center Singapore who was not involved in the study.
NDTV
4 days ago
- Health
- NDTV
New Hope For Patients With Less Common Breast Cancer
Virginia, United States: A new treatment nearly halves the risk of disease progression or death from a less common form of breast cancer that hasn't seen major drug advances in over a decade, researchers reported Monday. Results from the study, presented at the annual meeting of the American Society for Clinical Oncology, are expected to be submitted to regulators and could soon establish a new first-line therapy for people with HER2-positive metastatic breast cancer -- the advanced stage of a form that comprises 15-20 percent of all breast cancer cases. HER2-positive cancers are fueled by an overactive HER2 gene, which makes too much of a protein called human epidermal growth factor receptor 2 that helps cancer cells grow and spread. Patients with HER2-positive breast cancer that has spread to other parts of the body live around five years. "Seeing such a striking improvement was really impressive to us -- we were taking a standard and almost doubling how long patients could have their cancer controlled for," oncologist Sara Tolaney, chief of the breast oncology division at Dana-Farber Cancer Institute, told AFP. The current standard of care, known as THP, combines chemotherapy with two antibodies that block growth signals from the HER2 protein. The new approach uses a drug called trastuzumab deruxtecan (T-DXd), an antibody attached to a chemotherapy drug. 'Smart Bomb' This "smart bomb" strategy allows the drug to target cancer cells directly. "You can bind to the cancer cell and dump all that chemo right into the cancer cells," explained Ms Tolaney. "Some people call them smart bombs because they're delivering chemo in a targeted fashion -- which is how I think we're able to really increase efficacy so much." Common side effects included nausea, diarrhea and a low white blood cell count, with a less common effect involving lung scarring. T-DXd is already approved as a "second-line" option -- used when first-line treatments stop working. But in the new trial, it was given earlier, paired with another antibody, pertuzumab. In a global trial led by Ms Tolaney, just under 400 patients were randomly assigned to receive T-DXd in combination with pertuzumab, thought to enhance its effects. A similar number received the standard THP regimen. A third group, who received T-DXd without pertuzumab, was also enrolled -- but those results haven't yet been reported. 44 Percent Risk Reduction At a follow-up of 2.5 years, the T-DXd and pertuzumab combination reduced the risk of disease progression or death by 44 percent compared to standard care. Fifteen percent of patients in the T-DXd group saw their cancer disappear entirely, compared to 8.5 percent in the THP group. Because this was an interim analysis, the median progression-free survival -- meaning the point at which half the patients had seen their cancer return or worsen -- was 40.7 months with the new treatment, compared to 26.9 months with the standard, and could rise further as more data come in. Ms Tolaney said the results would be submitted to regulators around the world, including the US Food and Drug Administration, and that future work would focus on optimizing how long patients remain on the treatment, particularly those showing complete remission. "This represents a new first-line standard treatment option for HER2-positive metastatic breast cancer," said Dr. Rebecca Dent, a breast cancer specialist at the National Cancer Center Singapore who was not involved in the study
