BeiGene Ltd.

Anbogen collaborates with BeiGene to evaluate ABT-301 (HDAC inhibitor) and tislelizumab (anti-PD-1 antibody) in global Phase II trial for pMMR/MSS mCRC patients, aiming to address unmet needs in 95% of mCRC cases not benefiting from ICIs. The trial, set to start in Q1 2025, will assess safety, tolerability, and efficacy of combination therapy.

J&J's Talvey shows promise in multiple myeloma trials; FDA advisory committee votes against cancer immunotherapy use in certain digestive tract cancers; AbbVie's acquisition of Cerevel Therapeutics yields positive Parkinson's drug results; Roche's Gazyva succeeds in lupus nephritis Phase 3 study; Biogen terminates agreement with Sage Therapeutics over failed essential tremor drug; Enanta Pharmaceuticals' EDP-323 shows rapid antiviral effect against RSV.

The FDA’s ODAC voted 11 to 1 against the risk:benefit profile of anti–PD-1 antibodies in first-line treatment of metastatic or unresectable esophageal squamous cell carcinoma (ESCC) with PD-L1 expression < 1. Data from KEYNOTE-590, CheckMate 648, and RATIONALE-306 trials showed marginal or no benefit in patients with PD-L1 < 1 tumors, with efficacy questioned in PD-L1–low populations.

The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 11 to 1 against the use of checkpoint inhibitors (CPIs) in patients with metastatic or unresectable esophageal squamous cell carcinoma with PD-L1 expression less than 1, citing unfavorable risk-benefit assessment. The discussion focused on data from trials supporting the approvals of nivolumab, pembrolizumab, and tislelizumab, which showed marginal or unfavorable outcomes in patients with PD-L1 expression under 1, with higher benefits observed in those with expression over 1. The notable risks of CPIs, including immune-mediated adverse effects, were also highlighted.

FDA's ODAC voted 2 to 10 against favorable risk-benefit for CPIs in first-line HER2-negative gastric/GEJ adenocarcinoma with PD-L1 < 1. Discussions focused on data from nivolumab, pembrolizumab, and tislelizumab trials, highlighting clear benefits in PD-L1 > 10 and lack of benefit in PD-L1 < 1. FDA proposed product-specific vs. uniform PD-L1 cutoffs, considering safety and efficacy across PD-L1 strata. Clinical perspectives emphasized challenges in PD-L1 testing and the importance of patient-doctor discussions for intermediate PD-L1 values.

The FDA's ODAC voted 10-2 against PD-1 inhibitors in first-line HER2-negative, MSS gastric/GEJ adenocarcinoma with PD-L1 < 1, citing unfavorable risk:benefit. Data from CheckMate 649, KEYNOTE-859, and RATIONALE-305 trials showed OS benefits in higher PD-L1 subgroups, but not in those with PD-L1 < 1, raising concerns over toxicity and cost.

The FDA questions broad use of PD-1 inhibitors in gastric adenocarcinoma, suggesting limiting treatment to patients with specific biomarkers. This impacts Merck, Bristol Myers Squibb, and BeiGene, who market Keytruda, Opdivo, and Tevimbra, respectively. FDA analysis indicates PD-L1 as a predictive biomarker, with potential harm to patients with low PD-L1 expression. Merck and BMS argue for maintaining current approvals, while BeiGene supports consistent labeling and testing for anti-PD-1 agents.

S.K., D.A.M., J.P., H.S., X.Z., P.H., T.X., and H.S. have financial ties to various pharmaceutical companies, including stock ownership and advisory roles. F.C., J.D., E.V.C., H.S.W., T.Y., R.Y., and J.T. also report consulting or advisory roles and research funding from multiple institutions and companies.

Mantle cell lymphoma (MCL) treatment outcomes improve with novel targeted therapies like BTK inhibitors. DelveInsight's 'Mantle Cell Lymphoma Pipeline Insight 2024' covers 20+ companies developing 22+ therapies, including Venetoclax and ADI-001. Key events include AstraZeneca's Phase III ECHO trial and BeiGene's AACR presentation.

Israel's Ministry of Health approves BeiGene's TEVIMBRA for treating unresectable or metastatic oesophageal squamous cell carcinoma in adults who have undergone prior systemic chemotherapy. TEVIMBRA, a humanised anti-PD-1 monoclonal antibody, enhances the immune system's tumor-fighting capabilities. BeiGene plans further regulatory submissions for first-line OSCC and gastric cancer. TEVIMBRA has shown potential in improving survival and quality of life for various cancer patients and has been used to treat 900,000 patients globally.