BMS immunotherapy combo approved in aggressive thoracic cancer

Pharma News: Bristol-Myers Squibb (BMS) welcomed the Therapeutics Goods Administration (TGA) registration of its immunotherapy combination drugs for the first-line treatment of patients with unresectable malignant pleural mesothelioma (MPM).

This registration of Opdivo (nivolumab) plus Yervoy (ipilimumab) checkpoint inhibitor combo is based on results from CheckMate -743, the first and only positive Phase 3 immunotherapy trial in first-line MPM.

Dr Melinda Munns, Medical Director for BMS Australia and New Zealand said this TGA registration represents an important step in providing dual immunotherapy in the first-line unresectable MPM setting.

“With today’s registration of Opdivo plus Yervoy, we are one step closer to helping address the pressing unmet need for more effective, proven therapies for this aggressive cancer. We look forward to bringing the first immunotherapy combination that may offer a chance for a longer life to patients in Australia. We are committed to pursuing innovative approaches to cancer treatment, especially when there is a high unmet need.”

The trial met the primary endpoint of superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomised patients. Results from CheckMate -743 were published in The Lancet in January 2021.

In addition, 41% of patients treated with Opdivo plus Yervoy were alive at two years, compared to 27% with standard-of-care chemotherapy. Patients who responded to Opdivo plus Yervoy experienced lasting results – 32% of responders were still responding at two years vs. 8% with chemotherapy. The overall response rate for Opdivo plus Yervoy was similar to that of chemotherapy: 40% vs. 43%, respectively.

The safety profile for Opdivo plus Yervoy in first-line MPM was manageable and consistent with previous studies of the combination in other tumour types.

Malignant pleural mesothelioma is an aggressive thoracic cancer, with a five year survival rate of less than 10%. For more than 15 years, no new treatment options that can improve survival have been approved for unresectable malignant pleural mesothelioma, a cancer with high unmet need for more treatment options.

Australia has one of the highest incidence rates of mesothelioma in the world. Approximately 90% of mesotheliomas are pleural mesothelioma which is a rare type of cancer that starts in the cells in the linings of the lungs.

An indication in MPM adds another notch to the combo’s belt. Globally, the regimen also has approvals in melanoma, kidney cancer, liver cancer, among others.

This approval was granted under TGA Priority Review process that aims to expedite evaluation timeframes for treatments in areas of high unmet clinical need where substantial benefit has been demonstrated.

This registration was also part of Project Orbis, an initiative of the United States Food and Drug Administration (FDA) Oncology Centre of Excellence (OCE). Project Orbis seeks to increase collaboration among international regulators, while local regulatory agencies maintain its processes to make independent decisions about approval.