FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Locally Advanced Cutaneous Squamous Cell Carcinoma
Jul 07, 2021 03:34
CST Updated
03:34
MSD
Pharmaceutical R&D and Manufacturer
FDA
U.S. Food and Drug Administration
Cutaneous squamous cell carcinoma (cSCC, Image source: dovemed.com)
July 06, 2021 /BioonBIOON/ -- MSD (Merck & Co.) recently announced that the U.S. Food and Drug Administration (FDA）has approved an expanded indication for the anti-PD-1 therapy Keytruda (trade name: Keytruda; generic name: pembrolizumab): as a monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation therapy.
This latest approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, which showed:In the cohort of patients with locally advanced disease (n=54), Keytruda monotherapyThe objective response rate (ORR) was 50% (95% CI: 36-64), the complete response (CR) rate was 17%, and the partial response (PR) rate was 33%.. Among the 27 patients with a treatment response, 81% had a duration of response (DOR) ≥ 6 months, and 37% had a DOR ≥ 12 months.
In June 2020, Keytruda received its first indication for cSCC: as a monotherapy for the treatment of patients with recurrent or metastatic disease that cannot be cured by surgery or radiation therapy. Data from the KEYNOTE-629 trial show:Among patients with recurrent or metastatic cSCC (n=105), Keytruda monotherapyORR was 35%, CR was 11%, PR was 25%Among the 37 patients with a treatment response, 76% had a DOR ≥6 months and 68% had a DOR ≥12 months.
Dr. Vicki Goodman, Vice President of Clinical Research at MSD Research Laboratories, stated: "This approval is welcome news for these patients and further demonstrates MSD's commitment to the skin cancer community. Keytruda demonstrated meaningful efficacy in patients with locally advanced, recurrent, or metastatic cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation therapy. cSCC is the second most common non-MelanomaSkin cancer. This indication expansion strengthens the role of Keytruda in this type of cancer."
KEYNOTE-629 Clinical Data
KEYNOTE-629 (NCT03284424) is a multicenter, multicohort, nonrandomized, open-label phase 2 trial that enrolled patients with recurrent or metastatic cSCC or locally advanced cSCC. The trial excluded patients withAutoimmunitypatients with autoimmune diseases or patients with conditions requiring immunosuppressive therapy. In the trial, patients received Keytruda (200 mg intravenously every 3 weeks) until disease progression, unacceptable toxicity, or for a maximum of 24 months. Patients with disease progression after initial radiotherapy may receive additional doses of Keytruda during the confirmation of progression, unless disease progression is symptomatic, rapidly progressive, requires emergency intervention, or is associated with a decline in performance status.
Among 54 patients with locally advanced cSCC, the characteristics of the study population were: median age of 76 years (range: 35–95 years), 80% of patients aged ≥65 years; 41% of patients EasternTumorThe Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0, and 59% of patients had an ECOG-PS of 1. 22% of patients had received one or more prior therapies, and 63% had received prior radiotherapy.
The results showed that in patients receiving Keytruda monotherapy, the ORR was 50% (95% CI: 36–64), the CR was 17%, and the PR was 33%. After a median follow-up of 13.4 months, the median DOR was not reached (range: 1.0+ to 17.2+ months). Among the 27 responding patients, 81% had a DOR ≥ 6 months and 37% had a DOR ≥ 12 months.
Among the 159 patients with advanced cSCC (recurrent or metastatic or locally advanced disease) enrolled in this trial, the median duration of KEYTRUDA treatment was 6.9 months (range: 1 day to 28.9 months). Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC, compared with those in the 2,799 patients receiving Keytruda monotherapyMelanomaor in patients with non-small cell lung cancerAdverse ReactionsSimilar. The more frequent laboratory abnormalities (Grade 3–4) included lymphopenia (10%) and decreased blood sodium levels (10%).
Keytruda is a PD-(L)1 cancer immunotherapy that works by enhancing the ability of the human immune system to detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T cells that may affect`Tumor`T lymphocytes of cells and healthy cells.
To date, globally, there are already more than 10 PD-(L)1TumorImmunotherapy has been granted marketing approval, Keytruda is the leader in this field, and has been approved for multiple therapeutic indications,Global sales reached $14.38 billion in 2020.，representing a 30% increase compared to the previous year.
MSD has the largest immuno-oncology clinical development program in the industry, currently with over 1,500Clinical Trial`Investigating Keytruda in multiple types of`Tumor...and its role in the treatment context. The Keytruda clinical program aims to evaluate the drug's role in cancer and identify factors that may predict which patients will benefit from Keytruda treatment, including exploring several differentBiomarker. (Bioon.com)