Libtayo® (cemiplimab) now approved in Canada for the treatment of recurrent or metastatic cervical cancer

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  • Fourth Canadian Approval of Libtayo in Hard-to-Treat Cancers

MISSISSAUGA, ON, March 25, 2022 /CNW Telbec/ – Today, sanofi-aventis Canada Inc. (Sanofi) announced the approval of Libtayo® (cemiplimab) for the treatment of adult patients with cervical cancer who have progressed during or after platinum-based chemotherapy and who need additional systemic therapy to treat recurrent or metastatic disease. The approval is based on the Phase 3 EMPOWER-Cervical 1 study of cemiplimab in adults with cervical cancer (NCT03257267). The trial, which was the largest randomized clinical trial ever in advanced cervical cancer, included patients with recurrent or metastatic cervical cancer whose histology was either carcinoma squamous cell or adenocarcinoma. Participants were randomized to receive either cemiplimab or investigator-selected chemotherapy. The primary endpoint of the trial was overall survivalI.

Marc Surkadoctorate
Medical Chief in Oncology, Sanofi Canada
“While cervical cancer rates in Canada are fortunately in declineiidue in large part to the effectiveness of the HPV vaccine in preventing the formation of pre-cancers of the cervixiii, Canada still sees 1,400 women diagnosed with this condition each yeariv and who need treatment options. We are proud to have Libtayo approved for women who are diagnosed with recurrent or metastatic cervical cancer, and the healthcare professionals who treat them. »

Fourth indication of Libtayo in hard-to-treat cancers

With today’s announcement, Libtayo is now approved as an immunotherapy option for four advanced cancers:

  • In April 2019Libtayo has become the first immunotherapy option in Canada for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (SCCC) who are not candidates for curative surgery or curative radiation therapy.
  • In October 2021the availability of Libtayo has been expanded to include adults with advanced non-small cell lung cancer expressing PD-L1 in ≥ 50% of tumor cells (Tumor Proportion Score [TPS] ≥ 50%), as determined by a validated test, without EGFR, ALK, or ROS1 aberrations that have locally advanced NSCLC and are not candidates for definitive surgical resection or chemoradiotherapy, or metastatic NSCLC.
  • Also in October 2021, Libtayo was approved for the treatment of adults with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI).v

About cervical cancer

Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus that connects to the vagina. Human papillomavirus (HPV), which is a sexually transmitted infection, is implicated in most cases of cervical cancer, although the factors that lead an HPV infection to become cancerous are unknown.vi. Although cervical cancer is highly preventable and treatable, and Canada has set a goal to eliminate cervical cancer by 2040iiiin 2021, approximately 1,450 Canadians have been diagnosed with the disease and 380 have died from it.viii.

About Libtayo

Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T cells. By binding to PD-1, Libtayo has been shown to prevent cancer cells from using the PD-1 pathway to suppress T cell activation.

Libtayo’s extensive clinical program focuses on hard-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC, regardless of PD-L1 expression, and Libtayo in combination with conventional or novel therapeutic approaches for other solid tumors and blood cancers . These potential uses are experimental and their safety and effectiveness have not been evaluated by any regulatory authority.

Libtayo is jointly developed by Sanofi and Regeneron under a global collaboration agreement.

About Sanofi

We are an innovative global healthcare company driven by one purpose: we pursue the miracles of science to improve people’s lives. Our team, present in over 100 countries, is dedicated to transforming the practice of medicine by striving to turn the impossible into the possible. We provide potentially game-changing treatment options and life-saving vaccine protection to millions of people around the world, while placing sustainability and social responsibility at the center of our ambitions.

In CanadaSanofi employs approximately 2,000 people and in 2020 we invested more than $145 million in R&D in Canadacreating jobs, business and opportunity across the country.

Follow us on twitter @SanofiCanada
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

® Libtayo is a registered trademark owned by Sanofi Biotechnology and used under license.

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I https://www.clinicaltrials.gov/ct2/show/NCT03257267 Accessed March 14, 2022
ii The Canadian Cancer Society: Canadian Cancer Statistics 2021. Accessed March 7, 2022
iii Racey CS, Albert A, Donken R, Smith L, Spinelli JJ, Pedersen H, de Bruin P, Masaro P, Mitchell-Foster S, Sadarangani M, Dawar M, Krajden M, Naus M, van Niekerk D, Ogilvie G.: Rate of cervical intraepithelial neoplasia in British Columbia women: a population-level data linkage evaluation of the school-based HPV vaccination program. The Journal of Infectious Diseases. 2019;221(1);81-90
iv Canadian Partnership Against Cancer: Action Plan for the Elimination of Cervical Cancer in Canada. Accessed March 7, 2022
v Libtayo Product Monograph, March 23, 2022
vi The Mayo Clinic: Cervical Cancer. Accessed March 7, 2022
viii Canadian Cancer Society: Cervical Cancer Statistics. Accessed March 7, 2022

SOURCESanofi-Aventis Canada Inc.

For further information: Michael McDougall | 416-803-2218 | [email protected]

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