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.

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.

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.

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.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis from the CHRYSALIS study evaluating RYBREVANT® monotherapy and a combination regimen with lazertinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations who progressed after osimertinib.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced preliminary results from the Phase 1b CHRYSALIS-2 study evaluating RYBREVANT® in combination with lazertinib in the treatment of patients with non-small cell lung cancer characterized by epidermal growth factor receptor exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib and platinum chemotherapy.

New data for datopotamab deruxtecan, a TROP2 directed DXd antibody drug conjugate being developed by Daiichi Sankyo Company, Limited and AstraZeneca, show an encouraging tumor response rate in patients with advanced non-small cell lung cancer with actionable genomic alterations.