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Web Release
2 hours ago
- Business
- Web Release
Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL
Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This study enrolled patients with treatment-naïve CLL/SLL and those who had been previously treated but were BTK inhibitor-naïve. The study met its primary endpoint of non-inferiority on overall response rate (ORR) as assessed by an independent review committee (IRC) in both the pre-treated and intent-to-treat populations. ORR favored pirtobrutinib with a nominal P-value for superiority1 (p <0.05). Progression free survival (PFS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of pirtobrutinib. A formal PFS analysis testing for superiority is planned at a future analysis. No detriment was observed for overall survival (OS). BRUIN CLL-314 is the first ever head-to-head trial versus ibrutinib in CLL to include treatment-naïve patients. This important subpopulation (n=225) had the longest follow-up and a particularly pronounced PFS effect size in favor of pirtobrutinib. The overall safety profile of pirtobrutinib in BRUIN CLL-314 was similar to previously reported trials. Detailed results will be presented at a medical congress later in 2025. 'We launched the pirtobrutinib randomized development program with an ambitious suite of clinical trials, including head-to-head studies against modern standards of care and examinations of patient populations that reflect real world use, such as BTK inhibitor-pretreated patients,' said Jacob Van Naarden, executive vice president and president of Lilly Oncology. 'These data mark the second positive Phase 3 study in the program, as we continue to build evidence supporting the potential role of pirtobrutinib in treating people with CLL/SLL and hopefully enabling future regulatory approvals that allow physicians to use the medicine in various disease settings, whether treatment-naïve or BTK inhibitor-pretreated.' These data build on the previously reported positive results from the BRUIN Phase 1/2 trial and the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population. The BRUIN CLL-313 Phase 3 study of pirtobrutinib versus chemoimmunotherapy in treatment naïve CLL/SLL is expected to read out later in 2025 and combined with the results of BRUIN CLL-314, will form the basis of regulatory submissions globally. For more information on the BRUIN Phase 3 clinical trial program, please visit
Yahoo
30-07-2025
- Business
- Yahoo
Eli Lilly eyes SoC status as Jaypirca proves superior to Imbruvica in CLL/SLL
Eli Lilly's Jaypirca (pirtobrutinib) has been shown to be superior to Johnson & Johnson (J&J) and AbbVie's star Bruton's tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) in chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). Conducted in treatment-naïve patients with CLL and SLL, the first-ever head-to-head trial found that Lilly's oral therapeutic provokes a better overall response rate (ORR) in patients compared with Imbruvica. Topline results from the Phase III BRUIN CLL-313 (NCT05023980) trial do not yet include progression-free survival (PFS) as the value is not yet mature. However, preliminary trends suggest that the non-covalent BTK inhibitor can also extend PFS for patients in both indications. This builds on the positive results of the Phase III BRUIN CLL-321 trial (NCT04666038), which found that Jaypirca can reduce the risk of disease progression or death by 46% compared with Gilead's Zydelig (idelalisib) plus Biogen and Genentech's Rituxan (rituximab), and Teva Pharmaceuticals' Treanda (bendamustine) plus Rituxan. Jayprica poised to become SoC BTK inhibitors are a highly popular option for the treatment of B-cell malignancies such as CLL and SLL, with many physicians using them in the first-line setting. At the forefront of this drug class is Imbruvica, which raked in sales of $3.35bn in 2024 alone, according to AbbVie's 2024 financial report. However, a report from GlobalData, the parent company of Clinical Trials Arena, forecasts that Jaypirca is likely to become the BTK inhibitor market leader for CLL, with the therapy projected to make $5bn by 2032 — holding a 60% market share. The positive topline results of the BRUIN CLL-313 trial could also result in Jaypirca being considered as standard of care (SoC) in CLL and SLL, further enhancing the therapy's potential in this competitive market. Lilly's executive vice-president Jacob Van Naarden stated: 'The positive topline results of this Phase III study will help us to build evidence supporting the potential role of Jaypirca in patients with CLL and SLL — hopefully enabling future regulatory approvals that allow physicians to use the medicine in various disease settings.' "Eli Lilly eyes SoC status as Jaypirca proves superior to Imbruvica in CLL/SLL " 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
14-07-2025
- Business
- Yahoo
Ascentage Pharma's Novel Cancer Drug Approved in China
Ascentage Pharma Group International (NASDAQ:AAPG) is one of the best young stocks to buy and hold for 5 years. On July 10, Ascentage Pharma announced that China's National Medical Products Administration/NMPA approved its novel Bcl-2 selective inhibitor, called lisaftoclax (APG-2575). It treats adult patients with chronic lymphocytic leukemia/CLL and small lymphocytic lymphoma/SLL, particularly those who have previously received at least one systemic therapy, which includes Bruton's tyrosine kinase (BTK) inhibitors. Lisaftoclax is the first Bcl-2 inhibitor to receive conditional approval and marketing authorization for CLL/SLL in China, and the second Bcl-2 inhibitor approved globally. A scientist in a lab conducting research on cell-based therapeutics and biotechnology. Lisaftoclax is an orally administered small-molecule drug designed to treat malignancies by selectively blocking the antiapoptotic protein Bcl-2, thereby restoring the normal apoptosis process in cancer cells. Clinical trials have demonstrated its therapeutic potential in various hematologic malignancies and solid tumors, particularly CLL/SLL, both as a monotherapy and in combinations. Ascentage Pharma Group International (NASDAQ:AAPG) is a clinical-stage biotechnology company that develops therapies for cancers, chronic hepatitis B virus, and age-related diseases in Mainland China. While we acknowledge the potential of AAPG as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. 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
10-07-2025
- Business
- Yahoo
Ascentage Pharma Announces Its Novel Bcl-2 Inhibitor Lisaftoclax Approved by China NMPA, Ushering in a New Era for the Treatment of CLL/SLL
ROCKVILLE, Md. and SUZHOU, China, July 10, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton's tyrosine kinase (BTK) inhibitors, which makes lisaftoclax the first Bcl-2 inhibitor receiving conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally. Lisaftoclax is a proprietary, novel orally administered small-molecule Bcl-2 selective inhibitor developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. In the clinical trials, lisaftoclax has shown broad therapeutic potential in multiple hematologic malignancies and solid tumors, particularly in CLL/SLL, both as a monotherapy and in combinations. Furthermore, lisaftoclax is Ascentage Pharma's second commercialized novel drug following olverembatinib. This approval for lisaftoclax underscores Ascentage Pharma's outstanding capabilities in global clinical development and innovation, marking another major milestone in the Company's successful development of its deep pipeline. This approval is based on the results from a pivotal registrational Phase II study (APG2575CC201) that was designed to evaluate the efficacy and safety of lisaftoclax monotherapy in patients with relapsed or refractory CLL/SLL, with the overall response rate (ORR) as the primary endpoint. Lisaftoclax demonstrated compelling efficacy and an ORR that met the prespecified endpoint in patients who were previously treated with BTK inhibitors and/or immunochemotherapy. Moreover, lisaftoclax showed a favorable safety profile with no tumor-lysis syndrome (TLS) occurring during the study, a low incidence of hematologic toxicities which were manageable, and a low incidence of non-hematologic toxicities which were mostly grade 1-2. CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms. It primarily affects older populations with over 100,000 new diagnoses reported globally each year1. In China, where the incidence rate of CLL/SLL is lower than that of the western countries, the disease is occurring at a rapidly rising rate, with a younger age of onset and higher aggressiveness2. As the current primary option for the first-line treatment of CLL/SLL, BTK inhibitors have significantly improved treatment outcome for patients. However, BTK inhibitors still face a range of issues such as limited ability to induce deep responses, high risk of relapse in mid-and long-term treatment, toxicities and intolerability associated with prolonged treatment; thus, the need for safer and more effective treatment options for the patients with CLL/SLL. The introduction of Bcl-2 inhibitors has further revolutionized the treatment of CLL/SLL. The apoptosis suppressor factor Bcl-2, commonly overexpressed in a variety of hematologic malignancies, particularly CLL/SLL, is a key mechanism by which tumor cells evade apoptosis. However, the discovery of Bcl-2 inhibitor as a therapeutic target is highly challenging mainly because its mechanism of action is based on the protein-protein interaction (PPI). The binding interface of Bcl-2 is relatively large, making it difficult for small-molecule inhibitors to exert blocking effects. Additionally, the Bcl-2 protein, located on mitochondria with double-membrane structure, is among the most complex and challenging cellular components as it requires drugs to first penetrate the cell membrane before they can further act on the mitochondrial membrane. Prior to this, no Bcl-2 inhibitor had been approved for the treatment of CLL/SLL in China. This approval for lisaftoclax fills a treatment gap in CLL/SLL, bringing renewed hope to many patients in the country. Prof. Jianyong Li, Principal Investigator of the study from the Lymphoma Center at Jiangsu Province Hospital, noted, 'CLL/SLL is a common hematologic malignancy in aging societies, and its prevalence has been steadily rising in China. Despite advancements in treatment, patients with CLL/SLL still face a range of challenges such as drug resistance, long-term medical treatment that is difficult to manage, and disappointing response rates. In recent years, drugs targeting pro-apoptotic proteins have received widespread interest in the oncology field while Bcl-2 inhibitors have emerged as a new treatment strategy for patients with CLL/SLL. Globally, Bcl-2 inhibitors have already become a key part of the treatment of CLL/SLL, but no Bcl-2 inhibitor has been approved in China up till now. This approval for the next-generation Bcl-2 inhibitor lisaftoclax represents a timely response to the urgent unmet medical need of this patient population, effectively fulfilling the void for Bcl-2 inhibitors in CLL/SLL in China. As the first China-developed Bcl-2 inhibitor, lisaftoclax has demonstrated favorable efficacy and a unique safety profile, thus providing clinicians a new treatment option that can meaningfully improve the survival of patients with CLL/SLL. In April 2025, supported by its groundbreaking efficacy and safety data in Chinese patients with CLL/SLL, lisaftoclax was included in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies. The approval and guideline recommendations for lisaftoclax, the only Bcl-2 inhibitor approved in China for the treatment of CLL/SLL, validated the drug as a safe and efficacious new treatment option, underscoring a major advancement in precision therapy for hematologic malignancies in China.' Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, 'We are encouraged by the Chinese drug regulators' recognition of lisaftoclax's efficacy and safety, and would like to thank our investigators and their teams, and the patients for participating in the clinical study, for their efforts and trust. This approval for lisaftoclax is a milestone achieved through over a decade of committed research and clinical development by Ascentage Pharma. Lisaftoclax addresses an urgent unmet clinical need and brings a safe and effective new treatment option to patients with CLL/SLL. This represents another big step forward in our patient-centric global innovation. Lisaftoclax has broad therapeutic potential in multiple hematologic malignancies and solid tumors. We will accelerate the global development of this drug in various indications and bring it to more patients as soon as possible.' Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said, 'Our founding team has over 20 years of research experience in the field of apoptosis and accumulated deep expertise on the Bcl-2 target. This approval for lisaftoclax is a culmination of their dedicated research and a major milestone in our never-ending journey of innovation, further solidifying our leadership in the hematology field. As a proprietary novel drug developed through global innovation, lisaftoclax is a testament to our strength in drug development, bringing much needed change to the global landscape for Bcl-2 inhibitors. Moving forward, Ascentage Pharma will remain steadfastly committed to its mission of addressing unmet clinical needs in China and around the world and aspire to bring more innovative therapeutics to more patients globally.' Ascentage Pharma is currently conducting 4 global registrational Phase III trials of lisaftoclax: GLORA, an FDA-cleared study of lisaftoclax in combination with BTK inhibitors for patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response, as well as for the patients with newly diagnosed CLL/SLL in the GLORA-2 study, with newly diagnosed, elderly and unfit acute myeloid leukemia (AML) in the GLORA-3 study, and newly diagnosed higher risk myelodysplastic syndrome (MDS) in the GLORA-4 study. *In the United States, lisaftoclax (APG-2575) is an investigational compound and has not been approved by the US FDA. References Yao, Y., Lin, X., Li, F., et al. The global burden and attributable risk factors of chronic lymphocytic leukemia in 204 countries and territories from 1990 to 2019: analysis based on the global burden of disease study 2019. Biomed Eng Online. 2022 Jan 11;21(1):4. DOI: 10.1186/s12938-021-00973-6 Liu Peng. Practice guidelines for the diagnosis and treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma in Zhongshan Hospital, Fudan University (v1.2018). [J]. Chin J Clin Med, 2018, 25(1): 157-160. DOI 10.12015/j. issn. 1008-6358. 2018. 20180 About Ascentage Pharma Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) is a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers. The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation kinase inhibitors. The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients. The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. The NDA for the treatment of relapsed and/or refractory CLL and SLL just received approval by China's National Medical Products Administration (NMPA). The Company is currently conducting 4 global registrational Phase III trials: the GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with the SEC, including those set forth in the sections titled 'Risk factors' and 'Special note regarding forward-looking statements and industry data' in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed 'Forward-looking Statements' and 'Risk Factors' in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company's management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsInvestor Relations:Hogan Wan, Head of IR and StrategyAscentage 512 85557777 Stephanie CarringtonICR (646) 277-1282 Media Relations:Sean LeousICR HealthcareAscentagePR@ (646) 866-4012Error 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
India Today
02-06-2025
- Entertainment
- India Today
Exclusive: Good Boy's Park Bo-gum, Lee Sang-yi are ready for India, Bollywood
The excitement surrounding 'Good Boy' is sky-high, and at the heart of it lies a story that's as emotionally resonant as it is action-packed. Produced by SLL, th K-drama premiered on Prime Video and follows a group of former athletes who are recruited into law enforcement given their this exclusive conversation with India Today, the star cast—Park Bo-gum, Kim So-hyun, Lee Sang-yi, Heo Seong-tae, and Tae Won-seok opened up about what makes the drama special, their personal strengths as actors, and why a visit to India might be on the cards sooner than we is no secret that each actor brings a distinctive energy to their role in 'Good Boy', be it Bo-gum or Sang-Yi. When asked about their individual strengths, they offered candid, thoughtful insights. Park Bo-gum, who plays a boxing medallist, noted, 'Personally in the story, my character is the one in charge of fist fights. I think as an actor, what I am good at is having that active energy, being action-first, and being very agile, I would say that's one of my strengths.' Park Bo-gum: Photo credit: Prime Video, SLL For Kim So-hyun, it's her calm intensity that mirrors her character: 'The way her nature is very calm and grounded, and she's also very well-adjusted, and has a sense of boldness that comes from being calm. I think that's something that I share on a personal level as well." Kim So-kyun in a still from Good Boy'. Photo credit: Prime Video, SLL advertisementActor Lee Sang-yi, who was last seen in 'Spice Up Our Love', shared, 'When it comes to creating harmony and continuity between scenes, I like paying attention to that. I think it was similar for me as an actor and for my character."Heo Sung-tae, the charm machine, laughed, 'My character Man-sik is in charge of the beauty and the humour of the series. Look out for a lot of improvised scenes by me!' Tae Won-seok added with a grin, 'My character is adorable but strong—and I'm pretty strong in real life too.'Meanwhile, Bo-gum, who was last seen in the popular K-drama 'When Life Gives You Tangerines', may have fewer projects lined up, but his approach is anything but random. 'The first thing I look for is whether the script is entertaining to read,' he explained. 'Would I recommend this to someone? Would it make you think, talk about it with family? That's what matters.'As global demand for K-dramas grows, he adds, 'I know there are fans who study Korean and are curious about Korea through these shows. So, I'm more cautious about the dramas I choose to be part of.' India is perhaps one of the top nations that's quite vocal about their love for K-drama. The Hallyu wave here is real. When asked if the cast had any plans to visit India or participate in an Indian film, the answer was a resounding lit up at the mention of Indian dance and music: 'I love dancing and music. I'm going to go there.' Won-seok, with a smile, added, 'I lift my mood with Indian curry. I'd love to taste the original.'Bo-gum chimed in, 'India isn't just about great food. It has so much to offer. If given the chance, I'd love to travel there." He continued, "Hopefully, maybe all of us, the 'Good Boy' team, can star in an Indian musical film altogether."He ended on a heartfelt note: 'What's also really amazing is we didn't have a lot of chances to speak to or meet with Indian fans or the Indian media. And so, to be able to do something like this because you showed so much love for K-dramas, we are very grateful. It's a huge honour, and I feel very blessed."New episodes of Good Boy' drop every Friday on Prime Video. You May Also Like
