Sanofi/Regeneron Announce Phase 3 Success of Libtayo Plus Chemotherapy in First-Line Advanced Lung Cancer

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On August 5, Sanofi and Regeneron announced that the pivotal Phase 3 trial evaluating the PD-1 tumor immunotherapy Libtayo in combination with chemotherapy as first-line treatment for advanced lung cancer was terminated early due to highly significant efficacy observed in the preliminary analysis.

Both parties announced that the Phase 3 EMPOWER Lung trial for the treatment of advanced non-small cell lung cancer (NSCLC) has been terminated early, following the recommendation of the Independent Data Monitoring Committee (IDMC) after a pre-specified interim analysis. Both parties now plan to utilize these data to submit regulatory filings for approval in Europe and the United States.

As early as February this year, Libtayo entered the highly competitive lung cancer market when the U.S. FDA approved it as a monotherapy for the first-line treatment of patients with newly diagnosed locally advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS ≥50%). The recently announced phase 3 EMPOWER-Lung trial enrolled patients across all PD-L1 expression levels to evaluate Libtayo in combination with chemotherapy. Results demonstrated that, in these patients, Libtayo plus platinum-doublet chemotherapy significantly prolonged overall survival (OS) compared with chemotherapy alone.

The approval granted in February this year gives Libtayo the opportunity to compete with Merck’s immuno-oncology powerhouse, Keytruda. When Libtayo received its lung cancer approval, Geoffrey Porges, an analyst at investment bank SVB Leerink, predicted that peak sales for the drug in this indication would fall short of $1 billion, although he suggested that future combination therapies have the potential to improve its outlook.

Currently, in the first-line treatment of advanced lung cancer, immuno-oncology monotherapy is reserved only for patients who cannot tolerate chemotherapy, and the standard of care has shifted to Keytruda plus chemotherapy. In the KEYNOTE-407 study, which evaluated the Keytruda plus chemotherapy regimen for squamous NSCLC, interim analysis showed a 36% reduction in the risk of death compared with chemotherapy alone, with the reduction decreasing to 29% in the final analysis. For non-squamous NSCLC, interim analysis demonstrated that Keytruda plus chemotherapy significantly reduced the risk of death by 51% compared with chemotherapy alone.

The EMPOWER Lung trial evaluated the Libtayo plus chemotherapy regimen in patients with squamous and non-squamous NSCLC. Interim analysis demonstrated that Libtayo plus chemotherapy reduced the risk of death by 29% compared with chemotherapy alone. Median OS was 13 months in the chemotherapy arm versus 22 months in the Libtayo plus chemotherapy arm. Trial investigator and oncologist Miranda Gogishvili emphasized in a statement: "Notably, this Phase 3 trial evaluated Libtayo in patients exhibiting multiple characteristics of refractory disease."

Prior to its February approval for lung cancer, Libtayo was limited to skin cancer indications. The approval of its first-line monotherapy for non-small cell lung cancer (NSCLC) with high PD-L1 tumor expression (TPS ≥50%) marks a significant milestone on the drug's path to blockbuster status. However, combination therapy may ultimately be the key to achieving this goal.

In addition to lung cancer, Libtayo also received FDA approval in February for the treatment of basal cell carcinoma. Sanofi and Regeneron are also hoping to achieve success in cervical cancer. In May of this year, both companies announced positive Phase 3 clinical trial results for Libtayo in cervical cancer: among patients with recurrent or metastatic cervical cancer who had previously received chemotherapy, Libtayo significantly improved overall survival, progression-free survival, and objective response rate compared with chemotherapy, regardless of PD-L1 expression status.

Source: Libtayo is ending a lung cancer phase 3 early on positive data