Merck's KEYTRUDA Receives Approval in Canada for Adjuvant Treatment of Stage IIB or IIC Melanoma

Strategic Insights -

KEYTRUDA, an anti-PD-1 therapy developed by Merck, has been approved in Canada for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. This approval is based on the results from the Phase 3 KEYNOTE-716 trial, which demonstrated a statistically significant improvement in recurrence-free survival (RFS) for patients randomized to receive KEYTRUDA compared with patients randomized to placebo. With this new indication, KEYTRUDA is the first checkpoint inhibitor approved in Canada in the adjuvant space in Stage IIB or IIC melanoma.

Key Takeaways:

  • KEYTRUDA has been approved in Canada for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.
  • The approval is based on the results from the Phase 3 KEYNOTE-716 trial, which demonstrated a statistically significant improvement in recurrence-free survival (RFS) for patients randomized to receive KEYTRUDA compared with patients randomized to placebo.
  • The KEYNOTE-716 trial included 976 patients with completely resected stage IIB or IIC melanoma, and the primary efficacy outcome was investigator-assessed recurrence-free survival (RFS).
  • At the time of median follow-up (14.3 months), 11% (n=54/487) of patients who received KEYTRUDA had a recurrence or died compared to 17% (n=82/489) of patients who received placebo.
  • The most common treatment-related adverse events (reported in at least 15% of patients) were pruritis, fatigue, diarrhea, and rash.
  • KEYTRUDA was discontinued for treatment-related adverse events in 15% of patients in KEYNOTE-716.
  • This approval expands the indication for KEYTRUDA in Canada, making it the first checkpoint inhibitor approved in the adjuvant space in Stage IIB or IIC melanoma.
  • Merck's President and Managing Director, Marwan Akar, stated, "This approval is important for people living with melanoma and for all of us at Merck. With this new indication, KEYTRUDA is the first checkpoint inhibitor approved in Canada in the adjuvant space in Stage IIB or IIC melanoma, meaning it can be considered for patients earlier in their journey."

Statistics:

  • 976 patients were enrolled in the KEYNOTE-716 trial, with 487 receiving KEYTRUDA and 489 receiving placebo.
  • At the time of median follow-up (14.3 months), 11% (n=54/487) of patients who received KEYTRUDA had a recurrence or died compared to 17% (n=82/489) of patients who received placebo.
  • 15% of patients in KEYNOTE-716 had treatment-related adverse events severe enough to discontinue KEYTRUDA.

Sources:

  • KEYTRUDA Product Monograph. Merck Canada Inc. Updated August 18, 2022. Available at: https://www.merck.ca/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf
  • Canadian Skin Cancer Foundation. Malignant Melanoma. Taken from: https://www.canadianskincancerfoundation.com/skin-cancer/malignant-melanoma/.
  • Canadian Cancer Society. Melanoma Skin Cancer Statistics. Taken from: https://cancer.ca/en/cancer-information/cancer-types/skin-melanoma/statistics.
  • Government of Canada . Melanoma Skin Cancer. Taken from: https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/melanoma-skin-cancer.html.