The European Society for Medical Oncology’s annual conference wraps up in Copenhagen today. We’ve seen updates on heavyweight immunotherapy programs, potential options for patients with advanced breast cancer, and more. Here’s a quick roundup of the major news.
ESMO provided more evidence that the treatment of lung cancer is changing fast. Going into the meeting, pembrolizumab (Keytruda) from Merck (NYSE: MRK) had already leapfrogged (NYSE: BMY) nivolumab (Opdivo) from Bristol-Myers Squibb (NYSE: BMY) in the race to make checkpoint inhibitors, a type of cancer immunotherapy already approved for hard-to-treat skin, bladder, lung, and liver cancers, the standard of care for newly diagnosed lung cancer patients.
The first news of nivolumab’s Phase 3 failure in these first-line patients came in August and eliminated billions of dollars from Bristol’s market value. Conversely, Merck got a boost. At ESMO this weekend it reported more positive Phase 3 pembrolizumab data, particularly in patients whose tumors express high levels of a protein called PD-L1, while Bristol detailed nivolumab’s poor Phase 3 showing. (Both were compared to chemotherapy.)
Evercore ISI analyst John Scotti wrote in a research note that Bristol’s data were “even worse than expected,” widening the gap between the two drugs. Merck’s shares rose 1.6 percent Monday to close at $63.80 apiece, and Bristol’s fell 10.3 percent to $49.72. TheStreet.com has more on the data here.
Merck is expected to seek FDA approval of pembrolizumab in newly diagnosed lung cancer patients this year.
—Meanwhile, Roche’s Genentech division reported that its checkpoint blocker atezolizumab (Tecentriq) posted positive Phase 3 results in non-small cell lung cancer patients whose disease progressed after at least one round of chemotherapy. The FDA could approve atezolizumab for this group of patients within the next few weeks. The FDA approved atezolizumab earlier this year for a type of bladder cancer.
T CELL TIDBITS
—Among the three developers of CAR-T cell therapies pushing toward the field’s first approval, Kite Pharma (NASDAQ: KITE) was the sole presenter at ESMO. Santa Monica, CA-based Kite noted that three patients whose non-Hodgkin’s lymphoma was wiped out with Kite’s KTE-C19 remained in remission after 12 months. Kite recently reported that a larger group of NHL patients had a similar response to KTE-C19 after three months. CAR-T treatments use live, modified immune cells to attack a patient’s cancer.
—Adaptimmune (NASDAQ: ADAP), which is developing a form of cell therapy called T-cell receptor (TCR) therapy, updated its most advanced clinical program, a treatment for synovial sarcoma, which is a rare cancer that forms in the soft tissues around joints.
—ESMO was also the latest forum for data for cancer drugs known as PARP inhibitors. These drugs disable a mechanism that tumor cells use to repair their own DNA. The idea is to keep cancer from bouncing back after chemotherapy. The first PARP blocker to win approval was AstraZeneca’s olaparib (Lynparza), for certain forms of ovarian cancer, in 2014. But more seem poised for a green light.
Tesaro (NASDAQ: TSRO), of Waltham, MA, for instance, could win FDA approval of niraparib next year and make an impact on the treatment of ovarian cancer. Right now, surgery is the main option, followed by chemotherapy. But the cancer is stubborn, and there is a big need for “maintenance therapy”— drugs that delay the cancer’s recurrence. Phase 3 data from Tesaro show that adding niraparib to chemotherapy helps delay recurrence compared to chemo alone. Tesaro released top-line data from this trial in June, and investors cheered the better-than-expected results.
The company released detailed data at ESMO and published the results in the New England Journal of Medicine. The data solidified Tesaro’s case that nirapirib appears to help a broad group of ovarian cancer patients, not just those with a particular biomarker making them more likely to respond to treatment. (News that the drug might not need a companion diagnostic test from Myriad Genetics (NASDAQ: MYGN) sent the Salt Lake City test maker’s shares down more than 11 percent.) Tesaro expects to file for approval of niraparib next year. Some 20,000 women in the U.S. and Europe each year are eligible for maintenance therapy, according to Tesaro. Shares of the company climbed another 18 percent and closed at $117.90 apiece on Monday. Here’s more from OncLive.
—A rival PARP drug, rucaparib from Clovis Oncology (NASDAQ: CLVS), of Boulder, CO, didn’t fare as well this weekend. Clovis touted data from a “pooled” study of two mid-stage trials of rucaparib in ovarian cancer. The results, as Bloomberg noted here, underwhelmed investors, who sent Clovis shares down about 20 percent. Clovis aims to win FDA approval of rucaparib next year, and has recently been the subject of takeover speculation, which has caused shares to climb over the past several months. Pfizer, after all, paid $14 billion for Medivation earlier this year partly for a PARP drug in Phase 3 testing.
OTHERS OF NOTE
—Novartis revealed in May that its breast cancer drug ribociclib did so well in a 668-patient Phase 3 trial that the study was halted early. Novartis gave more details at ESMO and in the NEJM: Compared to the standard of care letrozole, ricociclib plus letrozole improved by 44 precent first-line patients’ chances to live without their cancer starting to grow again. The drug is meant for hormone dependent (HR+/HER2-) breast cancer and could compete with Pfizer’s palbociclib (Ibrance), which blocks the same cancer proteins, CDK 4 and 6, as ricociclib. Forbes weighed the ricociclib side effects here against the benefits of living longer without a growing tumor.
—Alex Lash contributed to this report