Health Canada has approved Tecentriq (atezolizumab) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) if they have not responded to platinum-based chemotherapy.
Lung cancer accounts for 24% of all cancer deaths. Each year, over 28,000 Canadians are diagnosed with lung cancer and over 21,000 dies from the disease. NSCLC accounts for 80-85% of lung cancer cases with a 5-year survival rate for patients with metastatic NSCLC of 2-13%.
Tecentriq is an anti-programmed death-ligand-1 (PD-L1) cancer immunotherapy administered intravenously infusied every 3 weeks. In a news release, Jeffrey Rothenstein, M.D., oncologist at R.S. McLaughlin Durham Regional Cancer Centre in Oshawa said, “The approval of Tecentriq for lung cancer is an important step forward as it’s the first and only treatment in Canada that specifically targets the PD-L1 ligand to boost patients’ immune systems to fight tumours. The clinical data show that Tecentriq is a good option for people with locally advanced or metastatic non-small cell lung cancer in their fight against this devastating disease.”
Shem Singh, Executive Director at Lung Cancer Canada added, “This new approval is an option that can help Canadians living with lung cancer fight the disease and perhaps gain more quality time with those they love.”
The approval of Tecetriq was largely based on results from the Phase 3 OAK study as well as the Phase 2 POPLAR study.
The OAK study was an open-label, multi-center, international, randomized study, that compared the efficacy and safety of Tecetriq (1200 mg by IV infusion every 3 weeks) to docetaxel (75 mg/m2 by IV infusion on day 1 of each 21-day cycle until disease progression.) in patients with advanced or metastatic NSCLC who have progressed during or following a platinum therapy (N=1225).
The primary efficacy endpoint was overall survival (OS) and the study found that patients taking Tecetriq had an OS time of 13.8 months compared 9.6 months for those taking docetaxel.
Similar trends were observed in the Phase 2 POPLAR study.
The most common adverse events are fatigue (26.8%), asthenia (19.0%), pyrexia (17.7%), nausea (17.7%), diarrhea (15.4%), constipation (17.6%), vomiting (12.2%), cough (23.2%), dyspnea (19.4%), arthralgia (12.0%), decreased appetite (23.5%), anemia (11.5%), musculoskeletal pain (10.5%) and back pain (11.0%).
Tecetriq is developed by Roche Canada. The approval of the drug by Health Canada means the drug will likely be available soon for patients with private health insurance but it will still be some time before it is available in the public provincial plans since those plans require additional reviews by each province’s and territory’s Ministry as well as by Canadian Agency for Drugs Technology and Health’s (CADTH) pan-Canadian Oncology Drug Review (pCODR).