Health Canada approves TECENTRIQ® (atezolizumab) for the treatment of patients with metastatic non-small cell lung cancer Français
TECENTRIQ provides a new cancer immunotherapy option for Canadians living with the difficult disease
MISSISSAUGA, ON, Apr. 9, 2018 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved TECENTRIQ® (atezolizumab) as a monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (aNSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving TECENTRIQ.1
TECENTRIQ is the first and only anti-programmed death-ligand-1 (PD-L1) cancer immunotherapy approved in Canada for lung cancer.2 It is administered by intravenous infusion every three weeks, which allows patients to attend fewer treatment sessions and spend more time doing what matters most to them.3
"The burden of lung cancer is significant and takes the lives of too many Canadians, so we continue to need new treatments to offer patients," says Dr. Jeffrey Rothenstein, Medical Oncologist, R.S. McLaughlin Durham Regional Cancer Centre. "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.4 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."
Lung cancer is the leading cause of cancer death among Canadians.5 In particular, non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 80-85% of cases in Canada.6 The estimated five-year survival rate for patients with highly advanced metastatic NSCLC is 2-13%.7
"Almost half of all lung cancer diagnoses in Canada are made when the cancer is already at its most aggressive and advanced stage.8 Immunotherapies are exciting new developments that offer lung cancer patients hope," says Shem Singh, Executive Director at Lung Cancer Canada. "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 TECENTRIQ approval is based on results from the Phase III OAK study and the Phase II POPLAR study.
About the OAK Study9
A phase III, open-label, multi-center, international, randomized study, GO28915 (OAK), was conducted to evaluate the efficacy and safety of TECENTRIQ compared with docetaxel in patients with aNSCLC who have progressed during or following a platinum-containing regimen.
A total of 1,225 patients were enrolled with both squamous and non-squamous disease, regardless of the PD-L1 status of their tumours. Participants were randomized (1:1) to receive either TECENTRIQ as a fixed dose of 1200 mg by IV infusion every 3 weeks until loss of clinical benefit, or docetaxel administered 75 mg/m2 by IV infusion on day 1 of each 21-day cycle until disease progression. The primary efficacy endpoint was overall survival (OS).
Results from the study showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (overall survival [OS]: 13.8 vs. 9.6 months; hazard ratio [HR] = 0.73, 95% confidence interval [CI]: 0.62, 0.87). An improvement in OS was observed with TECENTRIQ compared to docetaxel in both squamous and non-squamous patients and across levels of PD-L1 expression.
The safety of TECENTRIQ is based on use in 1,187 patients in the OAK study with aNSCLC who had progressed during or following a platinum-containing regimen. The most common adverse events in patients treated with TECENTRIQ (reported by ≥10% patients) were: 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%). The most common adverse events in patients treated with TECENTRIQ leading to dose interruption were pneumonia (2.1%), respiratory tract infection (1.0%), fatigue (1.1%), pyrexia (1.0%), dyspnea (1.6%), and back pain (1.3%).
About the POPLAR study10
A phase II, multi-center, international, randomized, open-label, controlled study GO28753 (POPLAR), was conducted in patients with aNSCLC.
A total of 287 patients were randomized (1:1) to receive either TECENTRIQ or docetaxel. Randomization was stratified by PD-L1 expression status in IC, by the number of prior chemotherapy regimens and by histology. The primary efficacy outcome was overall survival.
An updated analysis with a total of 200 deaths observed and a median survival follow-up of 22 months showed a median OS of 12.6 months in patients treated with TECENTRIQ, vs. 9.7 months in patients treated with docetaxel (HR of 0.69, 95% CI: 0.52, 0.92).
About TECENTRIQ
TECENTRIQ is the first and only anti-PD-L1 cancer immunotherapy approved in Canada and works by reactivating a patient's immune system to fight tumours. It is a monoclonal antibody designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells. This blocks the interactions of PD-L1 with both PD-1 and B7.1 cell-surface receptors which regulate the activation or suppression of T cells, a type of white blood cell that protects the body from infection and disease, including cancer. 11, 12, 13, 14
TECENTRIQ is currently being investigated globally in more than 200 clinical studies in a broad spectrum of cancer types, with one of the largest cancer immunotherapy programs in lung cancer, including several TECENTRIQ combination studies for which we anticipate data in 2018.
About Roche in Immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we're investing more than ever in our effort to bring innovative treatment options that help a person's own immune system fight cancer.
By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development program takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
About Roche in Lung Cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with the disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.
About Roche
Headquartered in Basel, Switzerland, Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Roche Canada was founded in 1931. The company employs over 1,000 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.
All trade-marks mentioned are the property of their respective owners.
© Copyright 2018; Hoffmann-La Roche Limited
REFERENCES
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| 7 Canadian Cancer Society. Survival for non-small cell lung cancer. http://www.cancer.ca/en/cancer-information/cancer-type/lung/prognosis-and-survival/non-small-cell-lung-cancer-survival-statistics/?region=on. Lat accessed February 5, 2018. |
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| 9 TECENTRIQ (atezolizumab) Product Monograph; April 6, 2018 |
| 10 TECENTRIQ (atezolizumab) Product Monograph; April 6, 2018 |
| 11 TECENTRIQ (atezolizumab) Product Monograph; April 6, 2018 |
| 12 Butte, M.J. et al. PD-L1 interacts specifically with B7-1 to inhibit T cell proliferation. 2007. Immunity, 27(1): 111-122. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2707944/. Last accessed February 5, 2018. |
| 13 National Cancer Institute. T-Lymphocytes. https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0022044/. Last accessed February 5, 2018 |
| 14 Jin, H.T. et al. Role of PD-1 in regulating T-cell immunity. 2011. Current Topics in Microbiology and Immunology, 350:17-37. https://www.ncbi.nlm.nih.gov/pubmed/21061197. Last accessed February 5, 2018. |
SOURCE Hoffmann-La Roche Limited (Roche Canada)
Claire Cockburn, Roche Canada, T: 905-542-4648, E: [email protected]; Tiffany Limgenco, Agnostic, T: 416-969-2843, E: [email protected]
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