BioSpace News Archive

One constant throughout the conversation is that the industry is at a different stage of adapting to the “new normal.”

The vote to offer a booster to those 65 and older, as well as immunocompromised individuals at high risk of developing severe COVID-19, was a unanimous “yea” at 18-0.

Novartis announced results of the final overall survival analysis of the Phase III MONALEESA-2 study, which evaluated Kisqali® in combination with letrozole compared to placebo plus letrozole in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer with no prior systemic treatment for advanced disease.

Merck, known as MSD outside the United States and Canada, announced the final overall survival results from the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with metastatic triple-negative breast cancer.

Mirati Therapeutics, Inc., a clinical-stage targeted oncology company, announced results from a cohort of the Phase 1/2 KRYSTAL–1 study evaluating adagrasib at the 600mg BID dose as both monotherapy and in combination with cetuximab in patients with heavily pretreated colorectal cancer harboring a KRASG12C mutation.

Junshi Biosciences announced that the US FDA has expanded the emergency use authorization for etesevimab 1,400 mg and bamlanivimab 700 mg administered together to include post-exposure prophylaxis in certain individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination.

Positive Phase 3 results for Sanofi and Regeneron Pharmaceuticals, Inc.’s Libtayo® combination treatment were presented during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021.

Verastem Oncology, a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced a mini oral presentation highlighting updated data from the ongoing investigator-sponsored Phase 1/2 FRAME study.

Seagen Inc. and Genmab A/S presented interim data from two cohorts of the phase 1b/2 innovaTV 205 multi-cohort, open-label trial of tisotumab vedotin in recurrent or metastatic cervical cancer at the European Society for Medical Oncology Virtual Congress 2021 as part of a featured mini oral presentation.

On September 19, 2021, CARsgen Therapeutics disclosed the latest progress of the investigator-initiated trial of Claudin18.2 CAR-T for the treatment of digestive system tumors.