News briefing: Jeffrey Leiden to chair Tmunity board of directors; Opdivo wins new approval in advanced RCC
Longtime Vertex CEO Jeffrey Leiden is taking on a new role.
Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.
Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.
Tmunity is currently evaluating its T-cell engineering approaches in the clinic with three programs.
The first targets metastatic castrate resistant prostate cancer, attacking the Prostate Specific Membrane Antigen. The second, meanwhile, focuses on patients suffering with pancreatic, ovarian, non-small cell lung and triple negative breast cancers by targeting Tn Mucopolysaccharide-1. And the third focuses on patients suffering from pancreatic, ovarian and lung cancer by targeting Mesothelin.
Opdivo plus Cabometyx wins approval for advanced RCC
Bristol Myers Squibb’s cash cow Opdivo has won a new indication.
The FDA approved the drug in combination with Cabometyx for the first-line treatment of patients with advanced renal cell carcinoma. Patients can take Opdivo as an injectable every two weeks at 240 mg, or every four weeks at 480 mg, while also taking Cabometyx pills once daily.
Friday’s approval was based on a Phase III study comparing the combination to Pfizer’s Sutent in patients with advanced RCC. Patients treated with Opdivo and Cabometyx lived twice as long without their tumors progressing as those treated with Sutent, notching a median progression-free survival of 16.6 months compared to 8.3 months.
A total of 651 patients were enrolled in the double-blinded study and were randomized 1 to 1.