- Incyte Corp. is pushing forward with late-stage clinical development of its experimental drug epacadostat, building out existing collaborations with Merck & Co. and Bristol-Myers Squibb in separate agreements announced two days apart.
- The Delaware-based biotech believes epacadostat, an inhibitor of the immunosuppressive enzyme IDO1, will work best in combination with other immuno-oncology agents. It's betting on the two leading checkpoint inhibitors: Merck's Keytruda (pembrolizumab) and Bristol-Myers' Opdivo (nivolumab).
- Incyte and Bristol-Myers plan to advance epacadostat and Opdivo into two Phase 3 studies in first-line non-small cell lung cancer (NSCLC) as well as head and neck cancer, matching planned late-stage trials with Merck pairing epacadostat with Keytruda in the same indications.
Why not both? The new agreements with Bristol-Myers and Merck advance development of epacadostat on similar tracks, furthering Incyte's combination strategy while protecting against disappointing activity from pairing the IDO1 inhibitor with one checkpoint inhibitor or the other.
With Keytruda, Merck and Incyte now plan to test the combo in five different tumor types across seven pivotal trials, including the ongoing ECHO-301 Phase 3 study in metastatic melanoma. The two companies will fund development, while Merck will lead clinical testing.
The agreement further broadens the two companies' existing agreement, which had been expanded just three months ago. Two Phase 3 studies will look at the combo in first-line NSCLC among both PD-L1 high-expressing patients as well as PD-L1 unselected patients. Other trials will look at first-line head and neck cancer, first- and second-line bladder cancer and first-line renal cell carcinoma.
Bristol-Myers and Incyte, on the other hand, will advance epacadostat and Opdivo into two Phase 3 studies, one in first-line NSCLC and the other in first-line head and neck cancer. Notably, the NSCLC study will test the combo "across the spectrum" of PD-L1 expression.
Analysts from Jefferies see the agreements as enhancing epacadostat's strategic positioning, while pitting Merck and Bristol-Myers' respective immunotherapies against each other. In the event epacadostat works with both Keytruda and Opdivo, physicians may see value in using epacadostat in combination regardless of which checkpoint inhibitor is used, Jefferies analysts wrote.
Incyte has a broad development program and has collaborations in place with Roche and AstraZeneca to test epacadostat in conjunction with their respective immunotherapies as well.
Yet, Incyte won't be without competition. NewLink Genetics is set to present data Tuesday at the American Association of Cancer Research meeting showcasing its IDO1 inhibitor indoximod. Abstract details are not yet posted online, but will include data from a Phase 2 study of indoximod in combination with Keytruda for patients with advanced melanoma.
Inclusion in the AACR program spurred a stock jump for NewLink last month and promising results could boost confidence further.