Pfizer Inc. and Merck & Co. Inc. have announced they will test Pfizer’s crizotinib (XALKORI®) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a multi-center, open label, Phase 1b clinical study evaluating the safety and tolerability of this combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC).
XALKORI is a kinase inhibitor approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have an anaplastic lymphoma kinase (ALK) mutation, an abnormal gene fusion promoting and maintaining the malignant behavior of cancer cells and appearing predominantly in non-smoker patients.
Pembrolizumab (MK-3475) is an experimental monoclonal antibody against PD-1, blocking the interaction between PD-1 on T cells with its ligands PD-L1 and PD-L2 on tumor cells. It belongs to a new class of immunotherapeutic drugs aimed at inhibiting immune checkpoints responsible for cancer progression, as these are crucial for an efficient anti-tumoral immune response by T cells. Pembrolizumab is currently being studied in more than 30 types of cancers, both as monotherapy and in combination and it is estimated to grow into more than 24 clinical trials, enrolling approximately 6,000 patients at nearly 300 clinical trial sites worldwide by the end of the year.
“This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers,” Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology said in a Pfizer press release. “Understanding the effects of combining one drug, XALKORI, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body’s immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients.”
These two companies had already announced plans to evaluate the safety and efficacy of pembrolizumab in combination with Pfizer’s small molecule kinase inhibitor axitinib (INLYTA®) in patients with renal cell carcinoma. Furthermore, pembrolizumab and Pfizer’s PF-05082566 (PF-2566), an investigational immunotherapeutic agent targeting the 4-1BB receptor on the surface of immune cells, will be evaluated in different types of cancer, with clinical trials expected to begin patient enrollment later this year.
“We are pleased to build upon our ongoing collaboration with Pfizer to evaluate potential combination regimens incorporating Merck’s investigational immunotherapy pembrolizumab. Evidence from early studies of pembrolizumab monotherapy together with XALKORI’s proven targeted therapeutic approach provides the scientific rationale for evaluating this combination for the treatment of lung cancer.” Dr. Eric Rubin, vice president, Oncology, Merck Research Laboratories added in the press release.