Health Canada approves LUMAKRAS™ (sotorasib), the first and only targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
Once daily dosing option now available to address KRAS G12C, a driver of tumour growth found in an estimated 10% - 15% of patients with non-small cell lung cancer1
MISSISSAUGA, ON, Sept. 14, 2021 /CNW/ - Amgen today announced that Health Canada has approved LUMAKRASTM (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. LUMAKRAS was granted a Notice of Compliance with Conditions (NOC/c) based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
"KRAS is a puzzle cancer researchers have been trying to solve for four decades," said Suna Avcil, executive medical director, Amgen Canada. "The first and only targeted therapy for patients with NSCLC who carry the KRAS G12C mutation, LUMAKRAS is a new option for these patients whose cancer has progressed beyond first-line therapy."
Health Canada based its approval of LUMAKRAS on results from a subset of patients in the phase 2 CodeBreaK 100 trial, the largest clinical trial conducted to date exclusively for patients with the KRAS G12C mutation.
The trial investigated efficacy and tolerability in 126 patients with KRAS G12C mutation-positive advanced NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy. The most common adverse reactions (? 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough. Adverse reactions resulting in permanent discontinuation of LUMAKRAS occurred in 9% of patients.
"Facing a difficult condition and an often-poor prognosis, patients with KRAS G12C-mutated non-small cell lung cancer have been in dire need of additional treatment options," says Dr. Mark Vincent, MB, ChB, MRCP(UK), FRCPC, medical oncologist, London Health Sciences Centre, London Regional Cancer Program. "Innovative treatments like LUMAKRAS (sotorasib) offer physicians and patients a new and important therapeutic option for these patients."
"Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined," says Shem Singh, Executive Director, Lung Cancer Canada. "We are pleased to see continued innovation, like this one in the area of KRAS G12C-mutated non-small cell lung cancer, that offers patients a treatment new choice as they and their physicians work together to manage their condition."
NSCLC accounts for approximately 84% of the 2.2 million new lung cancer diagnoses each year worldwide.2,3 KRAS G12C is one of the most prevalent driver mutations in NSCLC, with approximately 10% - 15% of patients with non-squamous NSCLC having the KRAS G12C mutation.1
About LUMAKRASTM (sotorasib)
LUMAKRAS was the first KRAS G12C inhibitor to enter the clinic and is being studied in the largest clinical trial conducted to date exclusively for patients with the KRAS G12C mutation.
LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced and metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.
As part of the evaluation for the conditional approval of LUMAKRAS in Canada as a second line therapy for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, Health Canada requires verification and description of clinical benefit in confirmatory trials.
LUMAKRAS is also being studied in multiple other solid tumours.4
Amgen submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia, Brazil, Canada and the United Kingdom in January 2021 to participate in the FDA's Project Orbis initiative – a pilot program that aims to explore a more efficient review process that ensures treatments are made available to patients as early as possible.
Consult the LUMAKRAS Product Monograph for more information.
About Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Overall survival rates for non-small cell lung cancer are improving, but remain poor for patients with advanced disease.5
KRAS G12C is the most common KRAS mutation in NSCLC.6 Approximately 10% - 15% of patients with non-squamous NSCLC harbor the KRAS G12C mutation.1 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with current therapies are suboptimal with a median progression-free survival of approximately 4 months following second-line treatment of KRAS G12C-mutated NSCLC.7
The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to treat patients with an advanced solid tumour with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumour types since its inception.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumours. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumour type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected later in 2021.
A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumours (CodeBreaK 101) open for enrollment.
For information, please visit www.hcp.codebreaktrials.com.
About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca and follow us on www.twitter.com/amgencanadagm.
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- Amgen. Data on File. 2020.
- American Cancer Society. Key Statistics for Lung Cancer. 2021. https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed May 20, 2021.
- Sung H, et al. CA Cancer J Clin. 2021;71(3):209-249.
- Hong DS, et al. N Engl J Med. 2020;383:1207-1217.
- American Cancer Society. Lung Cancer Survival Rates. 2021. https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 20, 2021.
- Arbour KC, et al. Clin Cancer Res. 2018;24(2):334-340.
- Aggarwal S, et al. Poster presentation at ESMO Virtual Congress 2020, Sep. 19-21, 2020. Poster 1339P.
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