Health Canada Approves Opdivo-Yervoy-Chemo Combo for Advanced NSCLC

Health Canada Approves Opdivo-Yervoy-Chemo Combo for Advanced NSCLC

Note: This story was updated Sept. 23, 2020, to note that the triple combination reduced the risk of death by 34%, not 37%.

Health Canada has approved a combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) plus two cycles of platinum-based chemotherapy for the treatment of metastatic non-small cell lung cancer (NSCLC).

The approval includes patients who have not received any form of systemic therapy for their metastatic disease and whose tumors contain no mutations in the EGFR or ALK genes.

It also marks the first time that a dual immunotherapy regimen, given alongside a limited course of chemo, has been approved in Canada to treat those with NSCLC.

“Receiving a diagnosis of advanced lung cancer is devastating,” Shem Singh, executive director of Lung Cancer Canada, said in a press release. “We welcome this new Health Canada approval for a novel treatment regimen for patients where there is still significant unmet need.”

Opdivo and Yervoy, both developed by Bristol Myers Squibb, belong to a class of medications known as immune checkpoint inhibitors and work by blocking the activity of proteins — PD-1 in the case of Opdivo and CTLA-4 in the case of Yervoy — that are often hijacked by cancer cells to avoid being targeted and destroyed by the immune system.

By blocking the activity of these proteins, these medications are expected to boost the activity and effectiveness of the body’s immune system at detecting and eliminating malignant cancer cells.

The combination Opdivo and Yervoy has been deemed beneficial in different types of cancer, and is approved for melanomalungcolonkidney, and liver cancers.

Health Canada’s decision to approve the Opdivo-Yervoy combo plus a limited course of platinum-based chemo was based on data from the CheckMate-9LA Phase 3 clinical trial (NCT03215706).

This open-label study is investigating whether this triple combo is a more effective first-line therapy for those with metastatic or recurrent NSCLC than conventional chemo (four cycles followed by optional maintenance therapy with pemetrexed).

Its main goal is to assess if the combination therapy is superior to standard chemo at prolonging patients’ overall survival. Secondary goals include the time patients live without disease progression, the percentage of patients responding to treatment, and survival outcomes in people with different PD-L1 levels. The amount PD-L1 in a tumor is often seen as a predictor of responses to agents like Opdivo.

After a minimum follow-up of 12.7 months, patients receiving the combination therapy lived longer (15.6 months) compared with those receiving chemo alone (10.9 months), representing a 34% reduction in the risk of death.

The time patients lived without disease worsening and responses to treatment were also better with the triple combo.

Importantly, these survival benefits were seen across different patient subgroups, and were independent of the levels of PD-L1 found within tumors and other features.

“Over four years ago, Opdivo became the first immunotherapy approved for use in previously treated patients, defining a new era and changing the way NSCLC is treated,” said Al Reba, general manager of Bristol Myers Squibb Canada. “We are so proud to build on this legacy as Opdivo plus Yervoy is approved as the first dual immunotherapy in a first-line NSCLC setting.”

“We are committed to pursuing innovative approaches to lung cancer treatment so we can continue to deliver the right medicines for patients, increase their quality of life, and improve their chances of survival,” Reba added.