First dual immunotherapy approved in non-small cell lung cancer

Pharma News: Bristol-Myers Squibb (BMS) welcomed the Therapeutics Goods Administration (TGA) registration of the first-ever dual immunotherapy plus chemotherapy for the treatment of non-small cell lung cancer (NSCLC).

OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) plus two cycles of platinum-doublet chemotherapy is now indicated for the first-line treatment of patients with metastatic or recurrent NSCLC, with no Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tumour aberrations.

The TGA approval was based on results from the randomised phase III clinical trial, CheckMate -9LA.

Associate Professor Tom John, Medical Oncologist at the Peter MacCallum Cancer Centre, welcomed the announcement that will bring new first line treatments to patients with NSCLC.

“Lung cancer is a complex disease, historically associated with low survival expectations for patients diagnosed at an advanced stage,” said Professor John.

CheckMate -9LA study results showed a statistically significant improvement in overall survival (OS) for previously untreated recurrent/metastatic NSCLC patients treated with OPDIVO, YERVOY and platinum-doublet chemotherapy compared to platinum-doublet chemotherapy alone at a prespecified interim analysis (at a minimum follow-up of 8.1 months, [HR 0.69; 96.71% CI: 0.55, 0.87; p=0.0006]).

Additionally, with longer follow-up (minimum of 12.7 months), dual immunotherapy with two cycles of chemotherapy continued to show sustained OS improvements over chemotherapy alone (median OS of 15.6 months versus 10.9 months, respectively [HR: 0.66, 95% CI: 0.55 to 0.80]).

The study met its primary and secondary endpoints, demonstrating superior OS, progression-free survival (PFS) and overall response rate (ORR) for the dual immunotherapy plus limited chemotherapy combination versus chemotherapy alone. The clinical benefit was observed across all efficacy measures in key population subgroups, including by PD-L1 expression and tumour histology.

“CheckMate 9LA shows how the addition of two cycles of platinum-doublet chemotherapy to the OPDIVO (nivolumab) plus YERVOY (ipilimumab) combination may benefit metastatic NSCLC patients, regardless of their PD-L1 status,” said Professor John.

According to Professor John, approval to use new combinations of medicines in first line lung cancer is crucial to improving patient outcomes.

“New approvals give clinicians additional options to consider. I think this TGA approval is very important given the clinical evidence behind it,” added Professor John.

Lung cancer is the leading cause of cancer deaths in Australia. Non-small cell lung cancer is the most common type of lung cancer, accounting for around 80% of cases.

Dr Melinda Munns, Medical Director for BMS Australia and New Zealand said “Each patient facing a diagnosis of recurrent/metastatic NSCLC is unique. This TGA registration demonstrates the commitment of BMS to provide first-line treatments for lung cancer patients. We are committed to pursuing innovative approaches to lung cancer treatment so we can continue to deliver the right medicine, to the right patient, at the right time.”

This TGA registration was facilitated through Project Orbis, an initiative of the United States Food and Drug Administration (FDA) Oncology Centre of Excellence (OCE).