MISSISSAUGA, ON,?Sept. 14, 2021?/CNW/ - Amgen today announced that Health Canada has approved LUMAKRAS^TM?(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 LUMAKRAS^TM?(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? About CodeBreaK 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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Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. References

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5. 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.
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7. Aggarwal S, et al. Poster presentation at ESMO Virtual Congress 2020,?Sep. 19-21, 2020. Poster 1339P.

SOURCE Amgen Canada