|Novartis cancer R&D chief Alessandro Riva|
Novartis ($NVS) is hitching a few of its cancer drugs to Bristol-Myers Squibb's ($BMY) closely watched clinical wagon for nivolumab (Opdivo). The pharma giant says it is now prepping new studies that will test how well three of its oncology drugs--the experimental INC280 and EGF816 and the newly approved ALK inhibitor Zykadia--do when combined with the PD-1 drug nivolumab in a joint attack on non-small cell lung cancer.
Underscoring Bristol-Myers' pedal-to-the-metal approach to developing new immuno-oncology combination therapies, the big biotech also announced plans today to collaborate with investigators at MD Anderson in Houston on up to 10 trials that will match nivolumab and Yervoy with a slate of the company's early-stage cancer drugs. Those studies will look to fast-track internal efforts on acute myeloid leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myelodysplastic syndrome and myelofibrosis.
"Preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients," said Dr. Alessandro Riva, who runs Novartis's cancer R&D efforts.
Indeed, that theory is now being tested in a full slate of Phase I/II combination approaches busily hatched by Bristol-Myers Squibb, Merck, Roche and AstraZeneca. The checkpoint inhibitors are given high marks for disabling a stealth mechanism used by cancer cells to escape detection by the immune system. And the big idea that Novartis and many others in the field want to know now that the checkpoint inhibitors are gaining pioneering approvals is seeing how much better these combination therapies may work together.
Zykadia, or ceritinib, gained an early approval for lung cancer just days ago on midstage data, making it possible to start marketing the drug--at $13,200 a month--just a little more than three years after hitting the clinic. Novartis landed INC280 in a package, $1 billion-plus licensing deal with Incyte 5 years ago. EGF816 is described as a "third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations."
Merck in particular has been busy on the partnering front with pembrolizumab, now approved as Keytruda as a treatment for melanoma. While Merck has notched the first U.S. approval for a checkpoint inhibitor, analysts have been paying particularly close attention to non-small cell lung cancer, which may offer one of the largest cancer markets for a checkpoint inhibitor.
Bristol-Myers filed the first application for a checkpoint inhibitor against lung cancer just days ago after winning the world's first approval in the field in Japan earlier this year.
These next-wave drug/checkpoint inhibitor combos are being tested alongside some combinations of PD-1 and PD-L1 therapies with cancer vaccines, which have been flopping as solo therapies in the clinic.