Mesothelioma Case Report Touts Success with Opdivo
July 23, 2018
Not every mesothelioma patient benefits from the immunotherapy drug Opdivo, but for the ones that do, the response can be lifesaving.
Opdivo, known generically as nivolumab, continues to produce dramatic results, inching it closer to FDA approval for mesothelioma cancer.
A recently published individual case report describes “an exceptional and sustained response.” Treatment with Opdivo allowed one patient to go from a downward spiral, with only weeks to live, back into the workforce.
“We were blown away by the patient’s response,” lead author Riley Jones, now in his fellowship at the University of Florida College of Medicine, told The Mesothelioma Center. “It was quite the turnaround.”
Immunotherapy Works After Chemo Fails
The patient was a 68-year-old male being treated at The Christ Hospital in Cincinnati, Ohio. He had undergone an aggressive extrapleural pneumonectomy (EPP) surgery.
Nine weeks after the operation, he began a cisplatin/pemetrexed chemotherapy regimen, but it failed to slow new tumor progression. His condition worsened quickly, and he required continuous oxygen supplementation.
“We thought he had about a month, possibly two, to live,” Jones said. “His decline was just terrible.”
Doctors then tried an Opdivo infusion given every two weeks, provided through the FDA’s Expanded Access program.
Within four weeks, the patient’s clinical improvement was dramatic, according to the case study. Within eight weeks, he was off all oxygen supplementation. Within four months, he was back at his job.
“This should provide some optimism, but I will say that a case report like this, something that works one time, is the lowest level of evidence,” Jones said. “Nobody should go running to their oncologist thinking it will work for everyone. That’s not how it should be interpreted.”
Opdivo Being Tested in Many Clinical Trials
There are currently nine different clinical trials throughout the world, at different levels and with different combinations, involving Opdivo and mesothelioma.
Many of those trials are showing promising results, but with disease control rates well below 50 percent.
Immunotherapy drugs like Opdivo work by unlocking the body’s immune system and allowing it to attack tumor cells. The effectiveness of immunotherapy typically depends on tumor molecular profiling.
The level of a certain protein expression — which varies from patient to patient — is linked to the level of anti-tumor immune response. But most clinical trials do not account for that protein expression when tabulating results.
“This is a whole new realm of treatment,” Jones said. “It’s really changing the way we treat all different sorts of cancers. You could see what it did here. This patient was very sick, but once he started nivolumab, he bounced back very quickly.”
Jones said this particular individual was the first of four mesothelioma cases at The Christ Hospital that experienced “a good, sustained response” to treatment with Opdivo. In each case, the side effects were manageable.
“This drug can cause these autoimmune problems, but it’s not the punch-in-the-gut sick like it is with some of the platinum-based [chemotherapy] therapies,” Jones said. “Overall, we found it to be pretty well tolerated.”
The patient in the case report started Opdivo treatments in 2014. He thrived for more than three years before dying of an unrelated illness.
Experimental Drug Working Well for Some
Mesothelioma survivor Gene Hartline also credits Opdivo for saving his life. He received the treatment from Dr. Rama Balaraman, an innovative medical oncologist with Florida Cancer Affiliates in Ocala.
Hartline was diagnosed in 2016. After standard chemotherapy showed little effectiveness, he was told at a much larger cancer facility that he had only a few months to live.
“I almost feel like I got my life back,” he said. “With this immunotherapy, I’m on the climb back up.”
The U.S. Food & Drug Administration (FDA) granted its first approval of Opdivo in 2014 for advanced melanoma. It has since been approved under various conditions for renal cell carcinoma, Hodgkin lymphoma and head and neck cancers.
Approval for Mesothelioma May Be Soon
Opdivo was approved by the FDA as a second-line treatment for non-small cell lung cancer in 2015. It was the first immunotherapy drug approved in that setting.
There are no second-line treatments currently approved for mesothelioma. Many oncologists believe this void will soon be filled by Opdivo or another immunotherapy drug such as Keytruda (pembrolizumab).
The FDA has not approved any new first-line treatments for mesothelioma since 2005. The majority of patients live less than 18 months after diagnosis.
“There is optimism out there. The preclinical data is starting to line up with the clinical tools that we now have,” Jones said. “Mesothelioma is still a very difficult disease — and there is still so much left to be learned — but we’re finally seeing some positive results.”