Bristol-Myers Squibb (BMS) and Incyte said today they launched a clinical trial collaboration aimed at assessing a combination of their cancer immunotherapy candidates. The value of the collaboration was not disclosed.
The companies will begin a Phase I/II study in the fourth quarter that is designed to evaluate the safety, tolerability and preliminary efficacy of BMS’ nivolumab, a PD-1 immune checkpoint inhibitor; and Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor INCB24360.
The study will assess the combination’s effect on multiple tumor types, which according to the companies could potentially include melanoma, non-small cell lung (NSCLC), ovarian, colorectal (CRC), squamous cell carcinoma of the head and neck (SCCHN) and diffuse large B-cell lymphoma (DLBCL). The Phase I/II study will be co-funded by the companies and conducted by Incyte.
Nivolumab and INCB24360 are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. According to BMS and Incyte, preclinical evidence suggests that the combination of Nivolumab and INCB24360 may lead produce a stronger anti-tumor immune response compared to either agent alone.
“Given the synergistic activity we have seen with our IDO1 inhibitor when combined with checkpoint inhibitors in preclinical models, and based on our emerging clinical data, we look forward to collaborating with Bristol-Myers Squibb to explore this combination across a wide range of tumor types,” Hervé Hoppenot, Incyte’s president and CEO, said in a statement.
INCB24360 has been shown to be effective in mouse models of cancer as a single agent and in combination with cytotoxic and immunotherapy agents. A Phase I dose-escalation trial showed that INCB24360 results in greater than 90% inhibition of IDO1 activity at generally well-tolerated doses.
INCB24360 is currently in Phase I/II development in combination with BMS’ Yervoy® (ipilimumab) for metastatic melanoma (NCT01604889) and as monotherapy for ovarian cancer (NCT01685255).
BMS has established a global development program to study nivolumab—as monotherapy or in combination with other therapies—in multiple tumor types consisting of more than 35 trials, in which more than 7,000 patients have been enrolled worldwide. Twenty of those trials were recruiting patients as of this morning, according to Clinicaltrials.gov. Among these are several potentially registrational trials in NSCLC, melanoma and renal cell carcinoma. Last year, nivolumab won the FDA's Fast Track designation in these three tumor types.
BMS and Merck & Co. are among drug developers scrambling to develop drugs targeting PD-1 or its complement, PD-L1. In February, Merck and Incyte launched a Phase I/II clinical collaboration to study the combination of INCB24360 with Merck’s investigational anti-PD-1 immunotherapy MK-3475 in a non-small cell lung cancer study.
Amgen, whose investigational oncolytic immunotherapy talimogene laherparepvec is being studied with the Merck compound in patients with previously untreated advanced melanoma; and Pfizer, which is studying how two of its compounds fight cancer when combined with MK-3475—the small molecule kinase inhibitor axitinib (Inlyta®) in renal cell carcinoma (RCC), and the immuno-oncology agent PF-05082566 (PF-2566) in multiple cancer types.