Health Canada has approved MSD’s anti-programmed cell death protein 1 (PD-1) therapy Keytruda for treating adults with resectable stage II, IIIA or IIIB non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy.
It is intended for use as a neoadjuvant treatment, followed by continued monotherapy as adjuvant treatment post-surgery.
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The decision by Health Canada is underpinned by the multicentre, double-blind Phase III KEYNOTE-671 trial outcomes, which showed a “statistically significant” improvement in event-free survival and overall survival when compared to the placebo plus chemotherapy regimen followed by only adjuvant placebo.
MSD Canada oncology business unit vice-president and executive director André Galarneau stated: “Today, we’ve made a significant step forward with the approval of the first anti-PD-1 therapy in Canada for the perioperative treatment of resectable non-small cell lung cancer.
“This approval highlights our commitment to expanding treatment options for lung cancer patients. We’re excited to continue this progress and collaborate with community partners to help patients affected by this disease.”
The randomised placebo-controlled trial evaluated the therapy in combination with chemotherapy, followed by surgery and adjuvant monotherapy.
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By GlobalDataEligible subjects for this trial included those with previously untreated and resectable Stage II, IIIA or IIIB (N2) NSCLC, as determined by the eighth edition of the American Joint Committee on Cancer.
The trial did not select subjects based on tumour PD-L1 expression levels. However, those with certain medical conditions, such as active autoimmune disease requiring systemic therapy within two years of treatment, or a history of interstitial lung disease/pneumonitis requiring steroid treatment, were excluded.
Keytruda functions by enhancing the immune system’s ability to identify and combat tumour cells. It first gained approval in Canada in 2015.
MSD previously received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sotatercept, branded as Winrevair, for the treatment of pulmonary arterial hypertension in adults.
