- French drugmaker and Bristol-Myers Squibb partner Innate Pharma on Monday revealed its experimental checkpoint inhibitor lirilumab failed to beat placebo in a Phase 2 trial studying the drug in elderly patients with acute myeloid leukemia (AML).
- Bristol-Myers, which licensed lirilumab from Innate back in 2011, sees lirilumab as potentially complementary to its immunotherapy star Opdivo (nivolumab) and recently read out positive interim results from a Phase 1/2 study combining the two against head and neck cancer.
- Per the 2011 deal, Innate had responsibility for progressing lirilumab as a monotherapy in CML through Phase 2. Unfortunately for Innate, lirilumab did not separate from placebo as measured against the primary endpoint of leukemia-free survival.
Originally a three-arm study, Innate's "EffiKIR" study had first hit a setback in March 2015 when an independent data safety monitoring board recommended the 1 mg/kg arm be discontinued.
Innate continued to test a 0.1 mg/kg dose of lirilumab against placebo, but Monday's topline results dashed those remaining hopes.
"Although we knew that this setting was challenging, we are disappointed by the results of the EffiKIR study and will investigate further to better understand the data in its entirety," said Pierre Dodion, chief medical officer at Innate Pharma.
Lirilumab is designed to block interactions between killer-cell immunoglobulin-like receptors and their ligands, thereby activating natural killer cells to attack tumor cells.
Bristol-Myers recently paid Innate Pharma a $15 million milestone payment after interim Phase 1/2 results pairing lirilumab and Opdivo showed show promise against squamous cell carcinoma of the head and neck. Bristol-Myers believes blocking KIR on natural killer cells and PD-1 receptors on T-cells could potentially enhance the benefit provided by Opdivo alone, especially in patients with high PD-L1 expression levels.
Other combo studies with lirilumab and various agents are ongoing across a range of cancer types. After Opdivo's surprising setback in first-line lung cancer last summer, many analysts and investors are paying more attention to Bristol-Myers' combination strategy, particularly with Opdivo and Yervoy (ipilimumab).
Innate Pharma stock fell nearly 14% in trading Monday on the Euronext Paris exchange.