BMS wins another lung cancer approval for its Opdivo+Yervoy combo


Bristol-Myers Squibb has won another first-line lung cancer approval from the FDA for its Opdivo and Yervoy immunotherapy combination. 

The big pharma has been playing catch-up with its rival Merck & Co whose rival immunotherapy Keytruda (pembrolizumab) was first approved in first line non-small cell lung cancer in 2016. 

Unfortunately for BMS the PD-1 class Opdivo came up short as a monotherapy but it has shown enough efficacy for approval when combined with the company’s other CTLA-4 immunotherapy, Yervoy (ipilimumab). 

The latest approval is in combination with two cycles of platinum doublet chemotherapy in untreated patients with non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumour mutations, regardless of expression of the PD-L1 biomarker. 

This follows approval earlier this month for the combination in first-line lung cancer in patients whose tumours test positive for the PD-L1 biomarker, without chemotherapy. 

Efficacy was investigated in CHECKMATE-9LA, a randomised, open-label trial in patients with metastatic or recurrent NSCLC. 

This compared the combination of Opdivo and Yervoy, plus chemotherapy in 361 patients, with 358 patients taking platinum-doublet chemotherapy. 

A blinded central review found progression-free survival was 6.8 months in the Yervoy and Opdivo arm, compared with five months in the chemotherapy arm. 

Overall response rate was 38% and 25% in the Opdivo and Yervoy arm, and the chemotherapy arm respectively. 

Median response duration was 10 months in the Opdivo plus Yervoy and chemotherapy arm, and 5.1 months in the chemotherapy arm. 

The FDA collaborated with regulators in Australia, Canada, and Singapore on the review and came to a decision two months ahead of schedule. 

The filing had already been granted a Priority Review lasting six months at the most, instead of the standard 10-month process. 

Singapore’s regulator is to make a near-simultaneous decision while the Australian Therapeutic Goods Administration and Health Canada are still reviewing the data. 

The FDA also used its Real-Time Oncology Review process to streamline data submission before filing of the clinical dossier, while BMS voluntarily used the Assessment Aid to help the FDA with its review.