Last week, Pfizer and Merck KGaA secured U.S. approval of their jointly developed checkpoint inhibitor avelumab in a rare cancer type, jumping into the now hotly contested immuno-oncology field.
The rush to bring a checkpoint inhibitor to market – AstraZeneca hopes to follow this year – mirrors the flood of industry investment into cancer research as a whole.
Some of that optimism will be on display at the upcoming annual meeting of the American Association for Cancer Research on April 1- 5 in Washington, DC, which will feature research on both current stars as well as up-and-coming treatment mechanisms such as IDO1.
Full abstracts with clinical results aren’t scheduled to be unveiled until March 31, but followers of Bristol-Myers Squibb, Incyte, Newlink Genetics and Kite Pharma will have new data to look forward to reviewing in short order.
Bristol-Myers Squibb, maker of the top-selling checkpoint inhibitor Opdivo (nivolumab), has seen its fortunes reverse since jumping out to an early lead in immuno-oncology. A major trial setback for Opdivo monotherapy in non-small cell lung cancer has pushed the conversation around checkpoint inhibitors further towards combination therapies.
For Bristol-Myers, the most important combination right now is a pairing of Opdivo with the anti-CTLA4 Yervoy (ipilimumab). But at AACR, the drugmaker will present a first look at its early-stage IDO1 inhibitor, both with and without Opdivo in a range of cancers. While the research is early-stage, it could give some insight into the potential of that combination.
IDO1 refers to an immunsuppressive enzyme that helps regulate a key metabolic pathway. Like PD-L1 or CTLA4 blockade, inhibiting that pathway is thought to help unleash a patient’s immune system to attack cancer cells.
Newlink Genetics has already got a boost from AACR, seeing its stock rise 18% after announcing it would present data from a Phase 2 study of its IDO1 inhibitor indoximod with Merck & Co’s Keytruda (pembrolizumab) in advanced melanoma.
And Delaware-based biotech Incyte will unveil pre-clinical data on its closely watched drug epacadaostat, another anti-IDO1 therapy. Incyte recently expanded a partnership with Merck to launch four new pivotal trials studying epacadostat with Keytruda across a range of cancers.
On the opposite end of the spectrum from early clinical forays, the AACR abstracts will also include longer term survival data for several marketed and recently approved drugs.
Bristol-Myers, an active participant in this year’s conference, will present initial overall survival data on Opdivo as both monotherapy and in combination with Yervoy for advanced melanoma.
Results from the Checkmate-067 study released in the summer of 2015 showed a 4.6-month and 8.6-month improvement in progression-free survival over Yervoy for the monotherapy and combo, respectively. According to clinicaltrials.gov, Checkmate-067 will include overall survival data up to 44 months.
Given that Opdivo is already approved in that indication, the results may have less of a regulatory impact but should provide insight on longer-term outcomes for patients on the checkpoint inhibitor.
Eli Lilly will also be shedding light on overall survival data from the MONARCH-1 study of its CDK 4/6 inhibitor abemaciclib. The Indianapolis drugmaker plans to submit a New Drug Application for the drug based on earlier MONARCH-1 data in the second quarter, and will follow that up with a supplemental application based on results from a second study, MONARCH-2, which recently read out positive.
As rival drugs from Pfizer and Novartis are already on the market, Lilly’s drug can use any competitive edge it can get to help make up ground.
ZUMA, Puma and more
Also at AACR, investors in Kite Pharma will get a deeper look at the ZUMA-1 data which Kite has submitted to the Food and Drug Administration for approval of its CAR-T therapy axi-cel.
The biotech has already disclosed that the therapy led to a complete response in 36% of patients with non-Hodgkin lymphoma after 6 months, likely setting up a landmark approval later this year.
More detailed results could alter that picture slightly, with the possibility of the response rate ticking up if some of the five patients with durable partial responses move into a confirmed complete response.
Elsewhere, Puma Biotechnology will present more data from its SUMMIT and CONTROL studies of its lead candidate neratinib in HER2-positive breast cancer. Puma recently suffered a damaging blow when Roche’s APHINITY trial testing Perjeta (pertuzumab) in a similar indication succeeded.
Another area to watch is early-stage research into fibroblast growth factor receptor (FGFR) inhibitors. Novartis, Incyte and Bayer will also be presenting abstracts touching on a range of pre-clinical and clinical candidates.