February 1st, 2021

// Amgen Presents Results From Phase 2 Cohort of CodeBreaK 100 Clinical Study Evaluating Investigational Sotorasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC)

Amgen Presents Results From Phase 2 Cohort of CodeBreaK 100 Clinical Study Evaluating Investigational Sotorasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC)

The results are the first from a completed pivotal Phase 2 study in NSCLC 
with a median follow-up of more than one year

MISSISSAUGA, ON, Feb. 1, 2021 /CNW/ - Amgen has announced results from the Phase 2 cohort of the CodeBreaK 100 clinical study evaluating investigational sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) and are the first from a completed pivotal Phase 2 study in NSCLC with a median follow-up of more than one year. Please note the safety and efficacy of sotorasib is still under investigation and market authorization has not been obtained.

Sotorasib demonstrated a confirmed objective response rate (ORR) and disease control rate (DCR) in previously treated patients with KRAS G12C-mutated advanced NSCLC. The results were also consistent with earlier Phase 1 results. Patients were treated with sotorasib 960 mg once daily orally, Prior to the trial, 81 % of patients had progressed on platinum-based chemotherapy and PD1/L1 inhibitors, with the remainder progressing after having received one of these therapies.

"There remains a significant unmet need for new therapeutic options to help support patients with advanced non-small cell lung cancer who have failed first-line treatment," said Suna Avcil, executive medical director, Amgen Canada. "Scientists and researchers around the world have invested four decades of research into trying to find these answers. We are encouraged by the results of this Phase 2 study and believe they offer important clinical insights."  

"I am pleased to see continued progress in the development of potential therapies for patients with advanced NSCLC harbouring a KRAS G12-C mutation," said Dr. Adrian G. Sacher, M.D., M.M.Sc., F.R.C.P.C., Division of Medical Oncology & Hematology Princess Margaret Cancer Centre.  "This research is critical to better understanding the disease and, more importantly, moving toward better patient care."

Most treatment-related adverse events (TRAEs) associated with sotorasib were mild to moderate (grade 1 or 2) and no treatment-related deaths. Grade 3 TRAEs were reported in 25 (19.8%) patients and 1 patient (0.8%) reported a Grade 4 TRAE. The most frequently reported TRAEs (any grade) were diarrhea (31.0%), nausea (19.0%), increased alanine aminotransferase (15.1%) and increased aspartate aminotransferase (15.1%). TRAEs led to treatment discontinuation in 7.1% of patients. 

NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at initial diagnosis.1,2 KRAS G12C is one of the most common driver mutations in NSCLC3 and there is a high unmet need and poor outcomes associated in the second-line treatment of KRAS G12C driven NSCLC.4 Approximately 13 per cent of patients with NSCLC harbour the KRAS G12C mutation.5,6

Following recent regulatory submissions in the U.S., European Union, Australia, Brazil, Canada and UK, Amgen is working with regulatory agencies across the globe to bring sotorasib to NSCLC patients as quickly as possible. Amgen's request for sotorasib to be considered for accelerated review under the Notice of Compliance with conditions (NOC/c) pathway in Canada was recently determined to be acceptable.

About Sotorasib

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.7 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents. In just over two years, the sotorasib clinical program has established the largest clinical data set with more than 700 patients studied across 13 tumour types to date.

About CodeBreaK

The CodeBreaK clinical development program for Amgen's investigational drug sotorasib is designed to study patients with an advanced solid tumour with the KRAS G12C mutation. 

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 in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumours (CodeBreaK 101) open for enrollment.

For information, please visit www.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.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

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References

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1 American Cancer Society. https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed January  2021. 
2 Ahmadzada T, et al. J Clin Med. 2018;7:153.
3 Liu P, et al. Acta Pharmaceutica Sinica B. 2019;9(5):871–879.
4 Pakkala S, et al. JCI Insights. 2018;3:3120858
5 Biernacka A, et al. Cancer Genet. 2016;209:195-198.
6 Cox AD, et al. Nat Rev Drug Discov. 2014;13:828-851.
7 Canon J, et al. Nature. 2019;575:217-223.

SOURCE Amgen Canada

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