AstraZeneca

HUTCHMED announced NMPA granted Breakthrough Therapy Designation to ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for EGFR mutation-positive NSCLC with MET amplification. The combination is being evaluated in China's Phase III SACHI trial, comparing its efficacy and safety to standard platinum-based chemotherapy.

HUTCHMED announces NMPA's Breakthrough Therapy Designation for ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) combo in EGFR mutation-positive NSCLC with MET amplification. The treatment is being evaluated in China's Phase III SACHI trial, comparing its efficacy and safety to standard-of-care platinum-based doublet-chemotherapy.

LYNPARZA (olaparib) showed sustained improvements in overall survival (OS), invasive disease-free survival (IDFS), and distant disease-free survival (DDFS) at six years for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer, reducing death risk by 28% vs. placebo. 87.5% of LYNPARZA patients were alive at six years vs. 83.2% in the placebo group.

HUTCHMED announces NMPA's Breakthrough Therapy Designation for ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) combo in EGFR mutation-positive NSCLC with MET amplification post-EGFR inhibitor therapy. The combo is being evaluated in China's Phase III SACHI trial, comparing its efficacy and safety to standard platinum-based chemotherapy.

HUTCHMED announces NMPA granted Breakthrough Therapy Designation to ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for EGFR mutation-positive NSCLC with MET amplification after EGFR inhibitor therapy. The combination is being evaluated in the Phase III SACHI trial in China, comparing its efficacy and safety to standard-of-care chemotherapy.

Ticagrelor's efficacy over clopidogrel is questioned as post-licensure studies show similar results with increased bleeding and dyspnoea. FDA approved ticagrelor despite objections from scientific review staff, leading to ongoing controversy over PLATO trial data reliability.

AstraZeneca's DAPA-MI trial demonstrated the feasibility of registry-based randomized clinical trials (R-RCT) for supporting new drug indications and informing medical practice.

Eli Lilly's experimental breast cancer drug, imlunestrant, met its main goal in a Phase 3 study, showing improved progression-free survival in HER2-negative, ER-positive patients. Combined with Verezenio, it offered longer survival and progression-free benefits. Imlunestrant, a next-gen SERD, aims to overcome resistance, particularly from ESR1 mutations. The trial enrolled 874 patients, with imlunestrant plus Verezenio reducing progression or death risk by 43% compared to imlunestrant alone. Side effects were higher with the combination treatment.

Candel Therapeutics' stock surged 172% after CAN-2409, a viral immunotherapy for localized prostate cancer, met its primary endpoint in a Phase III trial. The therapy, combined with radiation and valacyclovir, showed a 14.5% improvement in disease-free survival and a higher PSA rate, with a consistent safety profile. The company plans to use these results to seek FDA approval.