BeiGene Ltd.

CHMP recommends extended authorization for TEVIMBRA in gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma, based on RATIONALE-305 and 306 studies showing significant overall survival benefits with TEVIMBRA plus chemotherapy.

Study on MM treatment decision-making highlights QoL, duration of response, and side effects as top attributes for patients, care partners, and physicians. Differences in preferences and trade-offs underscore the importance of shared decision-making (SDM) to align treatment plans with patient values and improve outcomes.

Early-phase oncology trials now focus on efficacy with novel immunotherapeutic agents like bispecific antibodies and CAR T-cell therapy, necessitating refined trial designs, patient selection strategies, pharmacodynamics markers, and adverse event management. Submissions on exceptional toxicities, progress reviews, and early-stage clinical trials are welcomed.

Amy Abernethy's Highlander Health aims to streamline clinical research, leveraging data to reduce trial costs and duration, with initial funding for projects at Duke-Margolis, Baylor Scott & White Health, and Memorial Sloan Kettering Cancer Center.

Zymeworks Inc. to report Q3 2024 financial results on Oct 31, 2024, followed by a conference call at 4:30 pm ET. Zanidatamab, a HER2-targeted bispecific antibody, is under evaluation in global clinical trials and has BLA submissions accepted by the FDA and NMPA for Priority Review.

Scholar Rock's experimental SMA drug shows muscle function improvement in Phase 3 trial, paving way for regulatory approval. STAT highlights 12 influential figures in Chinese biopharma. Progeria advocate Sammy Basso, 28, dies from complications, leaving a legacy of resilience and scientific impact. Exact Sciences' Cologuard Plus receives FDA approval for colon cancer screening. Rwanda begins clinical trials for Marburg virus vaccine and therapeutics.

Global cancer cases surge, with a 79% rise in new cases among patients under 50. The highest death tolls are linked to breast, windpipe, lung, bowel, and stomach cancers. Cancer rates are projected to increase by 77% by 2050. In response, biotech firms like Oncolytics, AbbVie, BeiGene, HUTCHMED, and Enliven Therapeutics are accelerating treatment innovations, with the FDA approving 16 new oncology treatments in 2024. Oncolytics plans to submit a clinical trial for breast cancer treatment to the FDA in early 2025.

Recent Phase II data from iTeos and GSK's anti-TIGIT therapy belrestotug plus anti-PD-1 Jemperli shows promising response rates in NSCLC patients, despite high-profile failures in the TIGIT space. Despite setbacks, companies like Roche and Merck continue TIGIT studies, emphasizing trial design's impact on outcomes. Insights suggest anti-TIGIT therapy may benefit patients with high CD-155 expression, potentially as combination therapy. Recent positive results from iTeos/GSK and Gilead/Arcus indicate a possible turning tide in TIGIT therapeutics.

Onco360 selected as pharmacy partner by Beigene for Tevimbra® (tislelizumab), approved for treating unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. Tevimbra®, a PD-1 inhibitor, demonstrated improved overall survival in Phase III RATIONALE-302 trial. Onco360 committed to providing high-quality service for patients.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.