June 2 Quick Takes: Kisqali cuts recurrence risk in broad breast cancer population

Data presented at the American Society of Clinical Oncology meeting showed adjuvant treatment with Kisqali ribociclib from Novartis AG (SIX:NOVN; NYSE:NVS) plus endocrine therapy reduced the risk of invasive disease recurrence by 25% in stage II and III HR+/HER2- breast cancer patients, raising the question of whether enough data exist to support approval in the broad study population. In the 2,258-patient NATALEE study, 44 patients were node-negative — a population at a lower risk of disease recurrence than the node-positive patients included in other adjuvant studies. The small node-negative subpopulation had a greater risk reduction than the larger node-positive group (HR = 0.63 vs. 0.77), but a much wider confidence interval (0.341, 1.165). An approval for the entire study population would give Kisqali a broader label than competing CDK4/6 inhibitor Verzenio abemaciclib from Eli Lilly and Co. (NYSE:LLY), which is approved to prevent recurrence of node-positive disease in patients at high risk of recurrence.

Months after BioNTech SE (NASDAQ:BNTX) paid OncoC4 Inc. $200 million up front for rights to ONC-392/BNT316, interim data from a Phase I/II trial showed that the CTLA-4 inhibitor led to an overall response rate of 29.6%, including one complete response and seven partial responses, as monotherapy among 27 evaluable patients with PD-1/PD-L1-resistant non-small cell lung cancer. The companies said an immune-related adverse event rate of 30% was “lower than what was reported for similar drugs,” and they believe its reduced effect on regulatory T cells outside the tumor microenvironment is a differentiator for the program. A Phase III study, PRESERVE-003, is due to start next quarter. Data were presented at ASCO...