Libtayo Shows 6-Year Survival Benefit in NSCLC Trial

Libtayo (cemiplimab) improved survival and response rates compared with chemotherapy in patients with advanced non-small cell lung cancer, with 23% of those alive at six years in the EMPOWER-Lung 1 trial.

Dr. Miranda Gogishvili, a medical oncologist at the High Technology Medical Center, University Clinic in Tbilisi, Georgia, said the six-year follow-up showed a median overall survival of 26 months with Libtayo versus 13 months with chemotherapy, along with improved progression-free survival and a 46% response rate compared with 21%.

She noted that patients with PD-L1 expression of 50% or more benefited across all subgroups, with the greatest benefit seen in those with PD-L1 expression of 90% or higher.

Libtayo also showed a more favorable safety profile, with fewer grade 3 or higher treatment-emergent adverse events than chemotherapy, most commonly anemia, pneumonia and fatigue.

CURE: With six years of follow-up now available from the EMPOWER-Lung 1 trial, what stands out most about the long-term survival benefit seen with the drug compared with chemotherapy in this patient population?

Gogishvili: Well, with six-year follow-up, the trial demonstrated significant improvements in overall survival, progression-free survival, as well as objective response rate compared to chemotherapy. Key data points include 26 months median overall survival versus 13 months, representing a 40% reduction in the risk of death, and a 23% probability of survival at six years versus 13%.

Median progression-free survival was eight months versus five months, representing a 49% reduction in the risk of disease progression, and the objective response rate was 46% versus 21%.

So, at six-year follow-up, Libtayo monotherapy continues to demonstrate clinical benefit and prolonged overall survival and progression-free survival, as well as an acceptable safety profile compared to chemotherapy.

For patients with high PD-L1 expression, how should these findings shape conversations around choosing first-line treatment for advanced non-small cell lung cancer?

Well, anti–PD-1 and anti–PD-L1 inhibitors have become a critical component of systemic treatment for advanced non-small cell lung cancer without EGFR, ALK or ROS1 alterations.

At the time the EMPOWER-Lung 1 trial was initially designed, there was a need for additional treatment options that improved survival benefits and optimized chemotherapy-free treatments in patients with high PD-L1 expression, with only one agent in this class having shown superiority over chemotherapy.

Patients with PD-L1 expression of 50% or more benefit from Libtayo monotherapy. In our trial, all three subgroups — PD-L1 50% to 60%, 60% to 90% and 90% or more — demonstrated clinical benefit and better overall survival compared to chemotherapy. The greatest benefits were observed in the highest PD-L1 expression subgroup, PD-L1 greater than or equal to 90%.

As you said, the trial showed a survival rate of 23.8% at six years with the drug. How meaningful is this milestone for patients and their families?

It is very important for patients because Libtayo has a better safety profile, with fewer adverse events compared to chemotherapy, so it is very important for them and their caregivers as well.

Talking more about safety, what should patients know about tolerability with long-term use of the immunotherapy?

In our trial, we conducted a maximum number of treatment cycles of immunotherapy, and the safety profile for the Libtayo group was much better than the chemotherapy group, with grade 3 or more treatment-emergent adverse events at 45% compared to 51%.

Mostly, these were anemia, pneumonia and fatigue.

So, Libtayo monotherapy showed significant improvement in overall survival and progression-free survival, and the safety profile was better and consistent with previously reported data.

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