First dual immunotherapy regimen reimbursed for lung cancer

Pharma News: Bristol-Myers Squibb (BMS) welcomed the listing on the Pharmaceutical Benefits Scheme (PBS) of OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) with two cycles of platinum-doublet chemotherapy for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

This innovative regimen is built on the only approved dual immunotherapy foundation. The combination of Opdivo plus Yervoy has previously demonstrated long-term survival outcomes across melanoma and renal cell carcinoma.

This listing is the first-ever for dual immunotherapy plus 2 cycles of chemotherapy for the treatment of NSCLC. NSCLC accounts for around 85% of lung cancer cases.

Associate Professor Tom John, Medical Oncologist at the Peter MacCallum Cancer Centre, welcomed the announcement that will make new first-line treatments available to Australian patients who are affected by the squamous form of NSCLC.

“New evidence-based treatment options that are reimbursed are very welcome because lung cancer has historically been associated with low survival expectations for patients diagnosed at an advanced stage,” said Associate Professor John.

According to Associate Professor John, the reimbursement of new combinations of medicines in first-line lung cancer is crucial to improving patient outcomes.

“New listings give clinicians additional options to consider and trigger new conversations to have with our patients. Listings like this are important given the clinical evidence behind them,” added Associate Professor John.

Dr Melinda Munns, Medical Director for BMS Australia and New Zealand said this listing was positive news for suitable patients who would benefit from improved access to dual immunotherapy with chemotherapy treatment in the first-line NSCLC setting.

“This reimbursement is all about providing new, accessible and effective options for patients who have the squamous form of non-small cell lung cancer. It demonstrates the commitment of BMS to provide new first-line treatments for metastatic lung cancer patients,” said Dr Munns.

“As ever, BMS is 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. We look forward to working with the PBAC on making OPDIVO (nivolumab) plus YERVOY (ipilimumab) with two cycles of platinum-doublet chemotherapy a first-line option for non-squamous, stage IV non-small cell lung cancer patients.”

The PBS listing was based on results from the randomised phase III clinical trial, CheckMate -9LA, which provides important evidence for the clinical benefit of OPDIVO (nivolumab) plus YERVOY (ipilimumab) with two cycles of platinum-doublet chemotherapy vs chemotherapy alone. CheckMate -9LA study results showed a statistically significant improvement in overall survival 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]).

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