Incyte and Merck Agree to Expand Their Agreement Regarding Their Immunotherapy Combination Drugs

Incyte (INCY) and Merck (MRK) announced the expansion of their ongoing clinical collaboration to include a Phase 3 study evaluating the combination of epacadostat,Incyte’s investigational selective IDO1 inhibitor, with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy. The trial is for the use of the combination as first-line treatment for advanced or metastatic melanoma. The Phase 3 study, which is expected to begin in the first half of 2016, will be co-funded by Incyte and Merck.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. 

Epacadostat is also an immunotherapy drug that inhibits Indoleamine 2,3-dioxygenase 1 (IDO1) — an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer histologies.

Both drugs are designed to enhance the body’s immune system in fighting cancer.

Under the terms of the agreement Incyte and Merck have also agreed, for a period of two years, not to initiate new pivotal studies of an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist as first-line therapy in advanced or metastatic melanoma with any third party. During this time, the companies will each offer the other the opportunity to collaborate on any new pivotal study involving an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist for types of melanoma and lines of therapy outside of the current collaboration agreement.

Prohost Observations

Moving the clinical development program for epacadostat in combination with Keytruda into Phase 3 points to the expected huge promise of combining the two immunotherapy drugs. The combination has indeed showed promising results and is expected to improve the treatment outcome for advanced metastatic melanoma.

Keytruda has been approved and is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. The drug has also been recently approved for the treatment of non-small-cell lung cancer and in trial in combination with other drugs for various types of cancer.

Epacadostat is investigational and is in clinical trial in combination with other immunotherapy drugs for various cancers. The drug is showing promise.

We believe Incyte’s epacadostat is a great drug in Incyte’s pipeline. We believe that both drugs  will be blockbuster selling drugs and will treat a variety of late stage cancers  as well as early cancers.

This, indeed, good news.

An interesting phenomenon is that of the stock market understanding good news is if an order to sell the stock that has it.  The good news, though, is that in such cases, the battered stocks would rebound in a fierce way.

In the upcoming Prohost Letter read about successful biotech firms presentations at 

The 11th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS), held October 11 – 14, 2015, in Leiden, Netherlands.

The presenters include Celgene (CELG), Alnylam (ALNY) and others.

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