The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration, voted 13-4 that a regulatory decision on Incyte’s PD-1 inhibitor retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) should be deferred until further data are available from the clinical trial POD1UM-303.

Galectin Therapeutics is one of the only biotech companies with an active Phase IIb/III clinical trial for NASH cirrhosis. Galectin recently launched a site dedicated to its study, NAVIGATE: https://navigatenash.com/. Also, the Journal for ImmunoTherapy of Cancer recently published Phase I clinical research showing belapectin, Galectin Therapeutics’ galectin-3 inhibitor, enhances tumor response in combination with anti-PD-1 therapy. Med Ad News discussed these and other topics with Dr. Pol Boudes, CMO of Galectin. 

As the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting presents many clinical trial updates, there appears to be a theme: access to drugs and pricing.

Xilio Therapeutics is evaluating the company’s tumor-selective anti-CTLA-4 antibody XTX101 with Merck’s programmed death receptor-1 therapy Keytruda (pembrolizumab). The clinical trial – which will be conducted by Xilio – will assess XTX101’s safety and efficacy as a monotherapy, as well as in combination with Keytruda, in solid tumors.

Several biopharmaceutical companies submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration in recent weeks, covering treatment indications ranging from an opioid overdose to bipolar disorder and rare disease.

The U.S. Food and Drug Administration approved Merck’s Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Keytruda is the first anti-PD-1 therapy approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients.

A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.

The U.S. Food and Drug Administration approved GlaxoSmithKline’s new checkpoint inhibitor, Jemperli (dostarlimab), for patients with recurrent or advanced endometrial cancer.

GlaxoSmithKline halted two mid-stage studies assessing feladilimab combined with Merck’s Keytruda as a potential treatment in different oncology settings.

The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.