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Regeneron/Sanofi Libtayo+ chemotherapy: Phase 3 trials successful for advanced lung cancer
Libtayo+ chemotherapy: Phase 3 trials successful for advanced lung cancer . Regeneron/Sanofi Libtayo+ chemotherapy first-line treatment of advanced lung cancer phase 3 clinical trial success.
On August 5, Sanofi and Regeneron announced that the key phase 3 study evaluating PD-1 tumor immunotherapy Libtayo combined with chemotherapy for the first-line treatment of advanced lung cancer was terminated early due to the very significant efficacy in the initial analysis.
The two parties stated that the Phase 3 EMPOWER Lung trial for the treatment of advanced non-small cell lung cancer (NSCLC) was ended early in accordance with the recommendations given by the Independent Data Monitoring Committee (IDMC) after the pre-designated interim analysis. The two parties now plan to use the data to submit approval documents in Europe and the United States.
As early as February this year, Libtayo entered the highly competitive lung cancer market. At that time, the US FDA approved Libtayo as a monotherapy for the first-line treatment of newly diagnosed tumors with high expression of PD-L1 (TPS≥50%). Patients with locally advanced or metastatic NSCLC. The Phase 3 EMPOWER Lung trial announced this time enrolled patients with various PD-L1 expression levels and evaluated Libtayo combined with chemotherapy. The results showed that in these patients, compared with chemotherapy, Libtayo + platinum-containing dual-agent chemotherapy significantly prolonged overall survival (OS).
The approval in February of this year gave Libtayo the opportunity to compete with Merck’s immuno-oncology giant Keytruda. When Libtayo was approved for lung cancer, investment bank SVB Leerink analyst Geoffrey Porges predicted that the peak sales of Libtayo in the disease were less than $1 billion, although he hinted that future combination therapies have the potential to improve the drug’s prospects.
At present, in the first-line treatment of advanced lung cancer, monotherapy with immuno-oncology drugs is only used for patients who cannot tolerate chemotherapy, and the standard of treatment for this disease has shifted to Keytruda + chemotherapy. In the KEYNOTE-407 study, the combination of Keytruda and chemotherapy in the treatment of squamous NSCLC was evaluated. In the interim analysis, the risk of death was reduced by 36% compared with chemotherapy, and the reduction was reduced to 29% in the final analysis. In non-squamous NSCLC, an interim analysis showed that compared with chemotherapy, Keytruda+ chemotherapy significantly reduced the risk of death by 51%.
The EMPOWER Lung trial evaluated the Libtayo+ chemotherapy regimen in squamous and non-squamous NSCLC. The interim analysis showed that compared with chemotherapy, Libtayo+ chemotherapy reduced the risk of death by 29%. The median OS in the chemotherapy group was 13 months, while the median OS in the Libtayo+ chemotherapy group reached 22 months. The investigator and oncologist Miranda Gogishvili of the trial specifically emphasized in a statement: It is worth noting that this phase 3 trial evaluated Libtayo in patients with characteristics of multiple refractory diseases.
Before being approved to treat lung cancer in February, Libtayo was limited to skin cancer. The approval of its single-agent first-line treatment of tumors with high expression of PD-L1 (TPS≥50%) NSCLC marks an important step for the drug on its way to the ranks of blockbuster products. But the joint program may be the key to achieving this goal.
In addition to lung cancer, Libtayo also received FDA approval for the treatment of basal cell carcinoma in February. Sanofi and Regeneron also hope to win in cervical cancer. In May of this year, the two parties announced that the Phase 3 clinical trial of Libtayo for the treatment of cervical cancer had a positive result: In patients with relapsed or metastatic cervical cancer who had previously received chemotherapy, regardless of the expression status of PD-L1, Libtayo significantly improved compared with chemotherapy. Overall survival, progression-free survival, objective remission rate.
(source:internet, reference only)