Aug. 24 Quick Takes: Setbacks for Novartis, Odonate, Onconova, Tricida; plus upcoming adcomm for Alkermes, and Sinopharm’s vaccine

Novartis’ PD-1 misses in melanoma combo
Novartis AG (NYSE:NVS; SIX:NOVN) said spartalizumab missed the primary endpoint of the Phase III COMBI-i trial in patients with untreated, unresectable BRAF V600-mutant cutaneous melanoma. The PD-1 inhibitor, in combination with BRAF kinase inhibitor Tafinlar dabrafenib and MAP2K1/2 inhibitor Mekinist trametinib, failed to improve progression-free survival compared with the Tafinlar/Mekinist combo alone. The pharma said it plans to test spartalizumab in other tumor types.  

Odonate’s Phase III breast cancer data fails to impress 
Despite reporting that its metastatic breast cancer therapy tesetaxel met the primary endpoint of progression-free survival in a Phase III trial, shares of Odonate Therapeutics Inc. (NASDAQ:ODT) fell $15.21 (45%) to $18.33 Monday. Compared with a standard dose of capecitabine, tesetaxel plus a reduced dose of capecitabine reduced the risk of disease progression or death by 28.4% (HR=0.716, 95% CI: 0.573, 0.895; p=0.003). Odonate plans to submit an NDA for the oral semi-synthetic taxane derivative to FDA in mid-2021...