FDA approves Libtayo for advanced basal cell carcinoma
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The FDA granted regular approval to cemiplimab-rwlc for patients with locally advanced basal cell carcinoma who were previously treated with or ineligible for treatment with a hedgehog pathway inhibitor.
The agency also granted accelerated approval to cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals, Sanofi Genzyme), an anti-PD-1, fully human monoclonal antibody, for patients with metastatic basal cell carcinoma who previously received a hedgehog pathway inhibitor or for whom that treatment was not appropriate.
Basal cell carcinoma is the most common skin cancer in the U.S., with 2 million cases diagnosed each year. Cemiplimab-rwlc is the first FDA-approved immunotherapy indicated for patients with advanced forms of the disease, which are more difficult to treat, according to a manufacturer-issued press release.
“[This] FDA approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma,” Karl Lewis, MD, professor in the division of medical oncology at University of Colorado and an investigator on trials of the agent, said in the release. “Advanced basal cell carcinoma is a persistent, painful and highly disfiguring cancer. [Although] the primary systemic treatment options are hedgehog inhibitors, many patients will eventually progress on or become intolerant to this therapy. With Libtayo, these patients now have a new immunotherapy option that has demonstrated clinically meaningful and durable antitumor responses in locally advanced basal cell carcinoma.”
The FDA based this approval, in part, on data from the ongoing open-label, multicenter, nonrandomized Study 1620, which included 84 patients with locally advanced basal cell carcinoma who were not candidates for curative surgery or radiotherapy and 28 patients with metastatic basal cell carcinoma. All patients had progressed on, were intolerant to or had not had an objective response after 9 months on hedgehog pathway inhibitor therapy.
The patients received 350 mg cemiplimab-rwlc every 3 weeks for up to 93 weeks until disease progression, unacceptable toxicity or completion of treatment.
Confirmed objective response rate and duration of response served as the main efficacy outcome measures.
Researchers reported confirmed ORRs of 29% (95% CI, 19-40) among patients with locally advanced disease and 21% (95% CI, 8-41) among patients with metastatic disease.
Median duration of response was not reached for either cohort (locally advanced range, 2.1-21.4+ months; metastatic range, 9-23+ months), with 79% of responders in the locally advanced group and all responders in the metastatic group maintaining their responses for at least 6 months.
The most common adverse events included fatigue, musculoskeletal pain, diarrhea, rash and pruritis. Severe adverse events associated with treatment included immune-mediated adverse reactions, such as pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes and nephritis, and infusion reactions.
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