DTMT Network

The USbased pharmaceutical giant, Merck has announced recently that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection.

In a statement, Merck said that the CHMP has also recommended expanding the indications for Keytruda in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.

If approved, the drug would be the first anti-PD-1 immunotherapy treatment option for patients 12 years and older in the EU across stage IIB, IIC and III melanoma following complete resection, Merck said.

 “Based on the results of the KEYNOTE-716 trial, Keytruda has shown a significant improvement in recurrence-free survival and distant metastasis-free survival for these patients with resected stage IIB or IIC melanoma,” D. Scot Ebbinghaus, vice president of global clinical development at Merck Research Laboratories said.

“The CHMP’s positive recommendation brings us one step closer to providing patients 12 years and older in the European Union with a new option for resected stage IIB or IIC melanoma that can reduce the risk of their cancer returning” he added.

The company informed that during the trial, the drug demonstrated a statistically significant improvement in recurrence-free survival with KEYTRUDA compared to placebo (HR=0.65 [95% CI, 0.46-0.92]; p=0. 0.00658) in patients 12 years and older with stage IIB and IIC melanoma following complete resection.

It may be recalled that earlier in 2022, Merck reported that the trial had also met its key secondary endpoint of distant metastasis-free survival.

These results will be featured in a late-breaking oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5, Merck said.

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorisation in the European Union, and a final decision is expected in the second or third quarter of 2022, the statement added.