Pfizer Publishes Phase 3 Data For Xalkori

Pfizer announced that it has published the results of its late-stage study for Xalkori (crizotinib) as treatment for previously untreated anaplastic lymphoma kinase (ALK) -positive advanced non-small cell lung cancer (NSCLC).

Xalkori is a kinase inhibitor approved by the FDA for the treatment of patients with metastatic NSCLC whose tumors are verified ALK-positive. The drug is also approved in the EU for the same indication.

The company investigated Xalkori in the global, open-label, Phase 3 PROFILE 1014 study where it met the primary objective of significantly extending progression-free survival (PFS). The drug also showed a markedly higher objective response rate (ORR) compared to standard platinum-based chemotherapy. In March this year, Pfizer reported that Xalkori is the only agent to have shown significant PFS compared to chemotherapy in two studies of first- and second-line ALK-positive NSCLC.

“This study showed that XALKORI was superior to standard platinum-based chemotherapy regimens in previously untreated patients with ALK-positive advanced NSCLC. These data underscore the importance for all newly diagnosed patients to have their tumor tissue tested as early as possible for ALK gene rearrangements before determining the most appropriate treatment option,” said lead author Dr. Benjamin Solomon, of the Peter MacCallum Cancer Centre in Melbourne, Australia.

Dr. Mace Rothenberg, SVP of clinical development and medical affairs and CMO for Pfizer Oncology, said, “PROFILE 1014 is an example of what can be accomplished through precision drug development. ...This trial was able to demonstrate the superiority of XALKORI over an intravenous platinum-based chemotherapy regimen that has been a standard first-line treatment for more than a decade. We are delighted that these results are being published just 18 months after publication of PROFILE 1007, which demonstrated superiority of XALKORI over standard chemotherapy when used in the second-line setting to treat patients with ALK-positive advanced NSCLC.”

The company published the results in the first week of December issue of The New England Journal of Medicine.

Last month Pfizer announced that it had entered into partnership with German firm Merck KGaA to develop and market anti-PD-L1 therapy against a number of oncology targets. The agreement includes the co-promotion of Pfizer's Xalkori in the U.S. and other markets.