With Roche Data, Cancer Combos Post First Win Vs. Small Cell Lung Cancer

Xconomy San Francisco — 

Cancer immunotherapy combinations continue to chalk up wins against lung cancer. For the first time, an immunotherapy-chemotherapy combination has succeeded in a late-stage study of patients with small cell lung cancer (SCLC), a particularly aggressive form of the disease often linked to smoking.

Roche’s South San Francisco, CA-based Genentech division said today that in a 403-patient Phase 3 study called IMpower133, a combination of its immunotherapy atezolizumab (Tecentriq) and the chemotherapies carboplatin and etoposide performed better than the chemotherapies alone. Patients on the Roche regimen whose small cell lung cancer has spread to other tissues lived “significantly longer” than those on only chemo. Their cancers were kept from spreading longer as well, Genentech said in a statement Monday.

Genentech said the side effects seen with the combination “appeared consistent with the known safety profile” of the individual drugs. The companies didn’t provide specifics, however. Details will come at a future medical meeting.

Lung cancer remains by far the leading cause of cancer death. An estimated 154,050 people are expected to die from the disease in 2018, according to the American Cancer Society. But immunotherapy has already begun to change the way many patients are treated. It has become a pillar of treatment along with chemotherapy—which for decades was the main option for patients with advanced lung cancer—and targeted therapies, which home in on genetic mutations like ALK and EGFR. Most patients don’t have the mutations necessary for targeted therapy. Immunotherapy has begun over the past few years to make its mark in the large remaining pool.

Much of immunotherapy’s impact so far, however, has been seen with non-small cell lung cancer, which accounts for about 85 percent of all lung cancer cases. The FDA approved both Merck’s (NYSE: MRK) pembrolizumab (Keytruda) and Bristol-Myers Squibb’s (NYSE: BMY) nivolumab (Keytruda) in October 2015 for patients whose NSCLC had spread after chemotherapy. Then in 2016, pembrolizumab succeeded in a Phase 3 trial in newly diagnosed advanced NSCLC patients, but nivolumab failed. Pembrolizumab became the first FDA-approved immunotherapy to treat a portion of newly diagnosed lung cancer patients. Merck followed with an FDA approval of pembrolizumab plus chemotherapy in newly diagnosed patients.

This year there has been more progress. Merck disclosed that advanced NSCLC patients receiving just pembrolizumab lived much longer than those on chemotherapy in its Keynote-042 study. And at two big cancer meetings this year, the American Academy of Cancer Research’s (AACR) annual meeting in April and the American Society of Clinical Oncology’s gathering in early June, Merck, Bristol-Myers, and Roche all presented updates from studies of regimens that combined immunotherapies with other treatments. Taken together, they advanced immunotherapy as an option for bigger swaths of lung cancer patients.

There are no approved immunotherapies yet for SCLC, a fast-moving lung cancer that accounts for about 10 to 15 percent of cases, according to the ACS. Carboplatin/etoposide chemotherapy has remained the standard of care for years, and other immunotherapy regimens, like a Bristol combination of ipilimumab (Yervoy) and chemo, have previously failed. Things could soon change, however. Other approaches from Merck and Bristol are in clinical testing, and Bristol’s nivolumab is currently under FDA review for SCLC, with a decision expected by mid-August. With today’s data, Roche’s regimen could be the first combination treatment to market. The Swiss drugmaker will apply for approval with regulators in the U.S. and Europe.

Here’s more on immunotherapy’s growing role in lung cancer, and how doctors are integrating the different regimens.