Will Sanofi's Libtayo succeed in intractable cancer market?

Sanofi has confirmed its PD-1 inhibitor Libtayo (ingredient: cemiplimab-rwlc) lowers mortality in patients with cervical cancer following skin cancer, leaving an impressive mark as a latecomer.

Sanofi said Monday that it would end the phase 3 clinical trials of Libtayo for patients with recurrent and metastatic cervical cancer early, according to the Independent Data Monitoring Committee's recommendation.

Sanofi has confirmed its PD-1 inhibitor Libtayo (ingredient: cemiplimab-rwlc) reduces death risk in patients with cervical cancer.

In the studies, patients with advanced cervical cancer who received chemotherapy, regardless of PD-L1 expression, Libtayo improved the overall survival earlier than existing standard chemotherapy.

Libtayo reduced the risk of death by 31 percent compared to chemotherapy, with median overall survival increased from 8.5 months to 12 months.

Libtayo increased median overall survival by 27 percent from 8.8 months to 11.1 months in patients with squamous cell carcinoma. Those with adenocarcinoma who took Libtayo were 44 percent less likely to die, increasing median survival from seven months to 13.3.

Libtayo became the first immunotherapy to prove therapeutic effects in cervical cancer following cutaneous squamous cell carcinoma and basal cell carcinoma.

The first-generation PD-1 inhibitors developed by MSD's Keytruda (ingredient: pembrolizumab) and BMS's Opdivo (ingredient: nivolumab) have been recording the highest sale by taking up demands for lung cancer therapeutics, which has the largest market.

Besides, AstraZeneca's Imfinzi (ingredient: durvalumab), an immunotherapy inhibiting PD-L1, succeeded in treating early-stage lung cancer patients, and Roche's Tecentriq (ingredient: atezolizumab) also emerged as a promising drug for advanced hepatocellular carcinoma, which has a large market comparable to lung cancer.

Libtayo is the sixth PD-1/PD-L1 immune anti-cancer drug released by Sanofi, and the company believes it to be a promising anti-cancer drug pipeline.

Libtayo has received indications as first-line therapy for squamous cell carcinoma and basal cell carcinoma in advanced skin cancer and advanced non-small cell lung cancer. Sanofi plans to submit study results to the U.S. Food and Drug Administration by the end of 2021.

Sanofi's Libtayo, which has demonstrated superior efficacy for nonmelanoma skin cancer, is expected to show synergy with the marketing of the company's largest dermatology pipeline Dupixent (ingredient: dupilumab).

Libtayo is also expected to dominate the untapped fields as a second-mover by dominating the cervical cancer market, which lacked targeted treatment or immunotherapy.