The FDA approval is based on the Phase 3 CheckMate -743 trial, which evaluated Opdivo plus Yervoy compared to chemotherapy
Bristol Myers Squibb has secured the US Food and Drug Administration (FDA) approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat unresectable malignant pleural mesothelioma (MPM).
The FDA approval indicated Opdivo 360mg for three weeks, in combination with Yervoy 1mg/kg every six weeks for the first-line treatment of unresectable MPM in adults.
The pharmaceutical company said that the US regulatory approval is based on the interim analysis from the Phase 3 CheckMate -743 trial, which evaluated Opdivo plus Yervoy compared to chemotherapy, including pemetrexed and cisplatin or carboplatin.
In the clinical trial, Opdivo plus Yervoy showed superior overall survival (OS) in 18.1 months, compared to the platinum-based standard of care chemotherapy, in 14.1 months.
Study investigator Anne Tsao said: “Malignant pleural mesothelioma is a rare cancer with limited treatment options. When it is diagnosed in advanced stages, the five-year survival rate is approximately 10 per cent.
“The survival results from the CheckMate -743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option. This is exciting news, instilling hope for patients with this devastating disease and for the healthcare providers who care for them.”
Opdivo plus Yervoy is a combination of two immune checkpoint inhibitors PD-1 and CTLA-4
The FDA has approved the combination treatment in less than six weeks after the filing of a new supplemental Biologics License Application (sBLA), which was reviewed under its Real-Time Oncology Review (RTOR) pilot programme.
Also, the review was conducted under the FDA’s Project Orbis initiative, which enables simultaneous review by the health authorities in Australia, Brazil, Canada and Switzerland.
The company said that Opdivo plus Yervoy is a combination of two immune checkpoint inhibitors with a complementary mechanism of action, which target two different checkpoints, dubbed PD-1 and CTLA-4, to help destroy tumour cells.
The combination was previously approved by the FDA as a first-line treatment for patients with a type of metastatic non-small cell lung cancer (NSCLC), and is approved along with chemotherapy for the treatment of a type of metastatic or recurrent NSCLC.
The current approval marks the third indication for Opdivo + Yervoy-based combination as the first-line treatment for a type of thoracic cancer.
Bristol Myers Squibb general manager and oncology, immunology, cardiovascular head Adam Lenkowsky said: “Thoracic cancers can be complex and difficult to treat, and we are focused on developing immunotherapy options that may have the potential to extend patients’ lives.
“Just a few months ago, Opdivo + Yervoy-based combinations received two first-line indications for certain patients with non-small cell lung cancer. Now, Opdivo + Yervoy is approved for use in another type of thoracic cancer, previously untreated unresectable MPM.
“With today’s announcement, Opdivo + Yervoy becomes the first new systemic therapy approved in more than 15 years in this setting, and may offer these patients a chance for a longer life.”