FDA approves Cemiplimab as first immunotherapy to treat patients with advanced BCC.

As a monoclonal antibody medication, the FDA has approved cemiplimab (Libtayo) in order to treat patients with advanced BCC (Basal Cell Carcinoma), who have previously received treatment with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor has failed.

As a first immunotherapy, cemiplimab got the approval for the advanced basal cell carcinoma following the inhibition of hedgehog pathway. This approval was granted in order to treat those patients who are with locally advanced basal cell carcinoma. Apart from this, cemiplimab also got an accelerated approval for the treatment of patients who are with the metastatic disease.

According to a trial investigator Karl Lewis, MD, professor in the Division of Medical Oncology at the University of Colorado, “Approval of Cemiplimab will help in order to change the treatment paradigm for those patients who are with advanced BCC, which is mainly a persistent, painful, and quite disfiguring type of cancer. Approval of this drug (cemiplimab) will provide patients a new immunotherapy option that has demonstrated clinically effective as well as durable anti-tumor responses in patients with the locally advanced Basal Cell Carcinoma.”

The locally advanced setting approval was carried out in a primary analysis from a pivotal trial of phase 2, came out at the European Society of Medical Oncology Congress and the advanced setting approval was carried out in an interim analysis of a 2’nd cohort of the common study, came out at the 35th Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer.

In the open-label, multicenter, nonrandomized phase 2 trial, total enrolled patients were with the unresectable locally advanced/metastatic Basal Cell Carcinoma. It was basically the largest prospective clinical trial in this patient population. All the patients had either progressed on a hedgehog pathway inhibitor, were intolerant of the hedgehog inhibition, or the treatment was not effective even after the nine months. The cemiplimab treatment is recommended to be administered at 350 mg every 3 weeks until the progressive disease.

In a locally advanced cohort, among the 84 evaluable patients, the median considered age was 70 year (range, 42 to 89), about 60.7% had an ECOG performance status of 0, and the primary site of the disease was head as well as neck for about 89.3%.

Outcomes of a median follow-up of 15.1 months, the observed objective response rate was about 29% (95% CI, 19%-40%) in this cohort, which consisted of complete responses in about 6% and partial responses in about 23%. The median duration of response was not reached (range, 2-21+ months), and about 79% had responses lasting for minimum 6 months.

In the metastatic basal cell carcinoma cohort, there were a total of 28 evaluable patients, who followed for a median of 9.5 months. The overall response rate was about 21% (95% CI, 8%-41%), with the partial responses in all the patients. The median duration of response was not reached (range, 9-23+ months) and all the patients had responses lasting for minimum 6 months. The responses in this cohort were noted regardless of the PD-L1 expression levels.

The most commonly reported side effects included musculoskeletal pain, diarrhea, fatigue, rash, upper respiratory tract infection and pruritus, and in about 32% of patients reported some serious side effects include, colitis, urinary tract infection, acute kidney injury, anaemia, adrenal insufficiency, infected neoplasm and somnolence. About 13 percent of patients interrupted treatment due to adverse events, often because of physical health deterioration and colitis.

References:

https://www.cancernetwork.com/view/fda-approves-cemiplimab-as-first-immunotherapy-to-treat-patients-with-advanced-bcc

https://www.pharmacytimes.com/news/fda-approves-first-immunotherapy-for-patients-with-advanced-basal-cell-carcinoma

https://www.sanofi.com/en/media-room/press-releases/2021/2021-02-09-23-15-00

Cemiplimab is also approved in order to treat patients with the metastatic CSCC (Cutaneous Squamous Cell Carcinoma) or locally advanced Cutaneous Squamous Cell Carcinoma who are not suitable for the curative surgery/curative radiation. This PD-1 inhibitor is also under investigation for an indication in NSCLC, with relevant outcomes expected to come by this last month (February 2021).