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liquid biopsies. But these tests, which look for bits of tumor floating in a blood sample, are also being developed to use on patients already diagnosed with cancer. One liquid biopsy maker, Guardant Health, said at ASCO that comparisons across thousands of patients show its blood tests identify the same mutations as tissue biopsies a large percentage of the time.
IMMUNOTHERAPY COMBOS: THE VAST MATRIX
In one of Xconomy’s two ASCO previews, we highlighted the glut of immunotherapy combinations in clinical testing, and the potential backlash from the likely failure of many of these trials. Two days later, EP Vantage checked in with a tally of combo studies involving anti-PD-1 or anti-PD-L1 therapies. The 765 listed on clincialtrials.gov is more than triple the 215 running when EP Vantage checked in November 2015. Merck leads with 268 combo trials with pembrolizumab, followed by Bristol-Myers and its 242 nivolumab combination trials.
In this vast matrix of combinations, perhaps the most closely watched involves a class of drugs called IDO-1 inhibitors, named after the metabolic enzyme they target.
The hype surrounding these drugs is substantial: Incyte (NASDAQ: INCY), which leads the pack, is valued at more than $27 billion, even though its epacadostat has only produced data in small, early-stage trials. Incyte provided Phase 1/2 data from a combination of epacadostat and pembrolizumab in lung cancer patients, and a Phase 1/2 study of epacadostat and nivolumab in head-and-neck cancer patients.
Another type of combination worth watching involves what’s known as a PARP inhibitor, a relatively new class of drug already approved in ovarian cancer. A Phase 1/2 study called TOPACIO, for instance, combines FDA-approved niraparib (Zejula) from Tesaro (NASDAQ: TSRO) with pembrolizumab in ovarian or breast cancer patients. Tesaro provided initial data Saturday, with more mature results expected later this year. AstraZeneca has an early-stage study of its own on the way combining its PARP inhibitor olaparib (Lynparza) with its PD-L1 blocker, durvalumab (Imfinzi).
There was plenty of news about PARPs working alone, too. AstraZeneca made the case that olaparib could be the first one to break into breast cancer. The Phase 3 study OlympiAD compared olaparib to chemotherapy in HER2-negative patients with a specific genetic mutation. Olaparib reduced the risk of death in these patients by 42 percent; the results were published in the New England Journal of Medicine.
Pfizer acquired PARP blocker talazoparib when it bought Medivation in August 2016. It released Phase 2 results in breast cancer Saturday and reported that its Phase 3 trial for talazoparib is now fully enrolled.
With Novartis (NYSE: NVS) and Kite Pharma (NASDAQ: KITE) both hoping for an FDA approval, the field of T cell therapies known as CAR-T could see commercial daylight this year in two blood cancers where patients have had no luck with other treatments. Novartis’s product is for kids with acute lymphoblastic leukemia (ALL); Kite’s is for adults with non-Hodgkin lymphoma (NHL).
Beyond leukemia and lymphoma, however, the case for CAR-T is murkier, as Xconomy reported in March. One indication that has attracted several entrants is multiple myeloma, a cancer of plasma cells in the bone marrow. Early clinical studies began to report data late last year.
Bluebird Bio (NASDAQ: BLUE) continued its positive drip of Phase 1 data, and new entrant Nanjing Legend Biotech stepped into the spotlight with late-breaking data on 35 people in a trial being conducted in China.
PFIZER’S MEDIVATION GAMBLE TAKES A HIT
In that Medivation deal, Pfizer also wanted the successful prostate cancer drug enzalutamide (Xtandi). As Leerink Partners analyst Seamus Fernandez wrote in a note Monday, data at ASCO show how Medivation has gone from a coveted asset to an “exemplar of the dangers of competitive auctions and over-priced acquisitions.” Two studies published in the NEJM on enzalutamide rival abiraterone (Zytiga), from Johnson & Johnson (NYSE: JNJ), showed that abiraterone plus hormone therapy cut the risk of death in men with newly diagnosed, metastatic prostate cancer by a third compared to hormone treatment alone. The results, the study authors told Bloomberg, suggest that the front-line standard of care for these patients should change. Should that happen, Fernandez wrote, enzalutamide will largely get “pushed to the ‘back of the bus’ in terms of treatment sequence.”
PUMA RISES ON ROCHE BREAST CANCER DATA
Roche owns trastuzumab (Herceptin), the standard of care for HER2-positive breast cancer, but with looming generic competition it wants to extend the franchise. Its attempt to combine trastuzumab with its own pertuzumab (Perjeta), however, showed just the slightest benefit over trastuzumab alone. The weekend news briefly gave a 10 percent bump to the stock price of Puma Biotechnology (NASDAQ: PBYI), which has a next-generation HER2-positive breast cancer treatment under FDA review. Puma shares ended the day more modestly, with a 2 percent gain.
Photo of Chicago skyline by Tony Webster via Creative Commons.