Mesothelioma Drug Combination Continues to Show Promise
Pharmaceutical giant Bristol Myers Squibb continues to tout its immunotherapy combination of Opdivo and Yervoy for first-line treatment of patients with pleural mesothelioma cancer.
Bristol Myers Squibb recently announced that overall survival “significantly improved” when the combination was measured against standard chemotherapy in a randomized, phase III clinical trial of previously untreated mesothelioma patients.
Its announcement was based on a pre-specific interim analysis conducted by the Data Monitoring Committee, a clinical study organization independent of Bristol Myers Squibb.
The study is being conducted at 114 centers throughout the world, including 14 across the United States.
“These topline results from the trial demonstrate the potential of Opdivo plus Yervoy in previously untreated patients with malignant pleural mesothelioma,” Dr. Sabine Maier, development lead of thoracic cancers at Bristol Myers Squibb, said in a press release.
Maier declined requests to provide additional insight to The Mesothelioma Center at Asbestos.com.
Opdivo/Yervoy Clinical Trial Continues for a Year
The chemotherapy regimen involved Alimta (pemetrexed) and either cisplatin or carboplatin. Opdivo (nivolumab) was administered every two weeks and Yervoy (ipilimumab) every six weeks, up to four times. Therapy was received until there was unacceptable toxicity, disease progression or for a maximum of two years.
This clinical trial is expected to continue until April 2021. It was designed to measure overall survival, objective response rate, disease control rate and progression-free survival.
None of the measurements were included in the news release provided by Bristol Myers Squibb, which indicated results would be saved for presentation at a future medical conference.
The Lancet Respiratory Medicine published a phase II study from the Netherlands in 2019 with the same immunotherapy combination used in second-line treatment. It reported a six-month disease control rate of 50% and a median progression-free survival of 6.2 months.
Another second-line, phase II study from France published by The Lancet Oncology in 2019 showed a median overall survival of 15.9 months and an average progression-free survival of 5.6 months with the immunotherapy combination.
Immunotherapy Drug Combination Can Increase Effectiveness
Pleural mesothelioma is a rare and aggressive cancer most often caused by an exposure to asbestos fibers. Median overall survival, based on numerous studies, is less than one year. The five-year survival rate is an estimated 10 percent.
Diagnosis of pleural mesothelioma often comes late. Less than one-third of those diagnosed qualify for potentially life-extending surgery.
Both Opdivo and Yervoy are aimed at better harnessing the body’s own immune system and promoting an anti-tumor response, but they work by targeting different surface proteins.
Negating those proteins allows the immune system to better recognize and attack tumor cells. Both drugs have shown effectiveness individually with many cancers, including mesothelioma. A synergy between the two can increase that effectiveness.
This combination also is being studied at three of the leading specialty centers in the United States as a precursor to aggressive surgery for mesothelioma. The Sidney Kimmel Cancer Center at Johns Hopkins University, MD Anderson Cancer Center at the University of Texas and the Greenebaum Cancer Center at the University of Maryland are hoping to enroll a combined 30 patients in the study.
The Opdivo/Yervoy combination received approval from the U.S. Food and Drug Administration for the treatment of metastatic melanoma in 2015.
Individually, Opdivo and Yervoy have become a treatment option for several cancers. In various studies they are being used together for advanced renal cell carcinoma, metastatic colorectal cancer and hepatocellular carcinoma.