“Exelixis, Inc.EXEL, -1.02% today announced positive overall survival (OS) results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma carrying a BRAF V600 mutation. Exelixis’ collaborator Genentech, a member of the Roche Group, informed the company that coBRIM met its secondary endpoint of demonstrating a statistically significant and clinically meaningful increase in overall survival for patients receiving the combination of cobimetinib and vemurafenib, as compared to vemurafenib monotherapy. Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year. These data will be the subject of a presentation at an upcoming medical meeting.”
“The ECOG-ACRIN Cancer Research Group has opened the largest precision medicine cancer trial to date.
“The phase 2 National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) trial will evaluate the efficacy of targeted therapies in patients whose tumors share specific gene abnormalities. Treatment choice will be made based on these abnormalities rather than the site of origin of the malignancy.
“ ‘The primary underpinning of the trial comes from genetic characterization of various cancer types, which has become increasingly common place but is not yet routine,’ Keith T. Flaherty, MD, an oncologist at Massachusetts General Hospital, associate professor at Harvard Medical School andECOG-ACRIN chair of the NCI-MATCH trial, told HemOnc Today. ‘When looking at cancers as defined by their site of origin, there are threads of continuity across those cancer types. Within a cancer type, there also is heterogeneity, and understanding what this patchwork looks like was really the main motivator for setting up a trial like this.’ “
“Targeted treatments for cancer have been extending and saving lives for more than 15 years—precision medicine isn’t a new idea in oncology. Now drugs pioneered on select, specific cancers are, one by one, finding new applications.
“The first wave of targeted drug approvals were for cancers associated with specific mutations. Herceptin (traztuzumab) led the way, approved in 1998. It’s a monoclonal antibody deployed against the HER2/neu receptor that is overabundant in some aggressive and early-onset breast cancers. Robert Bazell’s excellent book Her 2 tells the tale.
“In 2001 came the blockbuster Gleevec (imatinib), a small molecule tyrosine kinase inhibitor that intercepts signals to divide. Erin Zammett’s My So-Called Normal Life with Cancer relates that story. A very young editor at Glamour magazine when a routine check-up revealed chronic myelogenous leukemia, Erin’s recovery was one of the first of thousands thanks to this now famous drug.”
“She had come to see me as a second opinion; diagnosed with uterine serous cancer, one of the more aggressive types of uterine cancers. At surgery they found that it had metastasized to her nodes—stage III disease. The surgery was successful, though, and she had been treated with adjuvant chemotherapy with the hope it was curative. Two years later, she developed abdominal pain. A work-up showed that her CA-125 was elevated, which prompted a scan, and a diagnosis of hepatic metastases. Her doctors recommended repeat treatment with chemotherapy—carboplatin and paclitaxel. ‘It didn’t work the first time, so I am not sure doing it all over again makes sense.’ “
“A new kind of cancer study supports the idea that traditional treatment can be turned on its head, with patients given targeted therapy based not on where their tumors started but on their own genetic mutations.
“Researchers used a targeted melanoma drug to treat patients with a range of cancers, from lung cancer to brain cancer, who weren’t being helped by traditional chemotherapy any more. Even though they had many different types of tumors, they all had one thing in common — a genetic mutation called BRAFV600.
“It’s a mutation familiar to doctors who treat melanoma, the deadliest form of skin cancer. It’s seen in about half of melanoma cases. A pill called vemurafenib, sold under the brand name Zelboraf, specifically targets the mutation. It helps about half of patients with melanoma who have the mutation.
“The same mutation is sometimes seen in colon cancer, lung cancer, thyroid cancer, brain tumors and some blood cancers.”