CLINICAL AND REGULATORY
CStone’s sugemalimab meets in esophageal squamous cell carcinoma
It’s the first anti-PD-L1 mAb to achieve positive results in the first-line setting, according to the company. Cejemly is approved by NMPA to treat NSCLC.
Tecentriq, Avastin reduce hepatocellular carcinoma recurrence
Roche said it was discussing data with regulatory authorities showing that the combination of Tecentriq atezolizumab and Avastin bevacizumab is the first to reduce the risk of recurrence in early-stage HCC patients following surgery. Overall survival data from the Phase 3 IMbrave050 study were still immature, the company added.
Merck reports mixed Phase 3 Keytruda results in billiary cancer
Merck Co continues its march into new indications with Keytruda pembrolizumab; this time with positive Phase 3 data in first-line biliary cancer. Prostate cancer indications, however, continue to prove challenging for the PD-1 inhibitor. Merck announced that Keytruda plus chemotherapy led to a statistically significant improvement in overall survival in the 1,069 patient KEYNOTE-966 study to treat advanced or unresectable biliary tract cancer, though the pharma has not yet disclosed the underlying data. Imfinzi durvalumab from AstraZeneca is the only PD-L1 inhibitor approved for the indication in the US. Merck also said the KEYNOTE-991 study of Keytruda plus Xtandi enzalutamide and androgen-deprivation therapy in patients with hormone-sensitive prostate cancer was stopped early due to futility. At an interim analysis, the combination failed to show an improvement in overall survival or radiographic progression-free survival vs. placebo plus enzalutamide and androgen-deprivation therapy. Last March, Merck stopped the KEYLYNK-010 study, which tested Keytruda plus Lynparza olaparib in castration-resistant prostate cancer patients, for futility. Then in August, Keytruda plus chemotherapy missed in the Phase 3 KEYNOTE-921 study in the same indication.
Broader label for Keytruda than Tecentriq in adjuvant NSCLC
FDA approved Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB, II, or IIIA non-small cell lung cancer (NSCLC), a broader label in the indication than that of Tecentriq atezolizumab. The Genentech Inc. drug is approved in the setting for patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells. FDA’s review was conducted under Project Orbis, an Oncology Center of Excellence initiative.