Phase 3 KEYNOTE-522 study data-based approval
Kirkland, Quebec, April 18, 2022 / CNW /-Merck (NYSE: MRK), known as External MSD united states of america When CanadaToday, Health Canada announces that it has granted KEYTRUDA approval.® (Pembrolizumab), Merck’s anti-PD-1 therapy for the treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) combined with chemotherapy as preoperative adjuvant therapy, followed by simple postoperative adjuvant therapy Continued as drug therapy.1 This approval is based on the results of the Phase 3 KEYNOTE-522 trial, demonstrating a statistically significant improvement in patient event-free survival (EFS) and pathological complete response (pCR) rates.1
“We welcome this approval from Health Canada as an important milestone for high-risk patients with early-stage triple-negative breast cancer,” said Dr. Jean-François. BoileauProfessor of Surgery, McGill University Surgical oncologist at Jewish General Hospital, Montreal. “Having new treatment options to treat this challenging subset of cancers is a valuable advance in this area of disease.”
In 2021, it was estimated that more than 28,000 Canadians were diagnosed with breast cancer.2 One of the most common cancers among Canadian women,2 TNBC is an aggressive subtype of breast cancer that tends to grow and spread rapidly.3 TNBC is also characterized by a high recurrence rate within the first 5 years after diagnosis.3 Many breast cancers have receptors for common therapeutic targets such as estrogen, progesterone, and HER2, but triple-negative breast cancer is negative in all three.3 This type of cancer is difficult to treat because there are few treatment options.Four
“We are proud that Keytruda has been approved for this indication in Canadian patients with triple-negative breast cancer.” Marwan Akar, President, and Managing Director, Merck Canada. “This is another step towards strengthening our unwavering commitment to research, science and innovation to support our patients.”
About the KEYNOTE-522 trial
health Canada’s Approval is based on the results of KEYNOTE-522, a phase 3 randomized, double-blind clinical trial that enrolled 1,174 patients.1 Eligibility criteria for this study are tumor-independent, previously untreated, high-risk early-stage TNBC (tumor size> 1 cm but with lymph node metastases less than 2 cm in diameter or tumor size> diameter regardless of lymph node metastases. Expression of PD-L1 newly diagnosed as 2 cm).1
The primary efficacy outcome measures were pathological complete response (pCR) and event-free survival (EFS). pCR was defined as the absence of invasive cancer in the breast and lymph nodes and was evaluated by local pathologists who were blinded during radical surgery. EFS was defined as the time from randomization to the first occurrence of any of the following events: disease progression that interferes with radical surgery, local or distant recurrence, secondary primary malignancies, or something. Death due to cause.1 The KEYNOTE-522 results showed a statistically significant improvement in pCR and EFS in patients randomized to receive KEYTRUDA.® Chemotherapy followed by adjuvant KEYTRUDA® As a monotherapy compared to patients randomized to placebo in combination with chemotherapy followed by placebo alone.1
About Triple Negative Breast Cancer
TNBC is an aggressive subtype of breast cancer that lacks estrogen receptors, progesterone receptors, and HER2 amplification, making therapeutic targeting difficult.Five TNBC has the highest incidence of metastatic disease and has the shortest overall survival of all breast cancer subtypes.Five Characteristically, the recurrence rate is high within the first 5 years after diagnosis and tends to be more common in women under the age of 40.3
About KEYTRUDA®
KEYTRUDA® Is an anti-PD-1 therapy that works by helping boost the body’s immune system to help detect and fight tumor cells.1 KEYTRUDA® Activates T lymphocytes that block the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby affecting both tumor and healthy cells. It is a humanized monoclonal antibody.1
KEYTRUDA® First approved by Canada In 2015, now several including advanced renal cell cancer, bladder cancer, non-small cell lung cancer, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial cancer, esophageal cancer, triple negative There are indications in the disease area of bladder cancer, melanoma, and squamous cell carcinoma of the head and neck.1
Focus on cancer
Our goal is to transform progressive science into innovative oncology drugs to help cancer patients around the world. At Merck Canada, it is our passion to help people fight cancer and our commitment to support accessibility to our cancer treatments. Our focus is on pursuing oncology research, which can accelerate every step of the journey from the lab to the clinic and bring new hope to cancer patients.
About Merck
For over 130 years, Merck has been known outside of MSD united states of america When CanadaHas provided medicines and vaccines to many of the world’s most difficult illnesses and invented them for life in pursuit of our mission to save and improve life. We demonstrate our commitment to patient and population health by increasing access to health care through a wide range of policies, programs and partnerships. Today, Merck remains at the forefront of research to prevent and treat human and animal-threatening diseases (cancer, infectious diseases such as HIV and Ebola, new animal diseases, etc.) and is research-intensive. We aim to be the best biopharmaceutical company. in the world.For more information on our business at CanadaVisit www.merck.ca, connect with us on YouTube, twitter @MerckCanada
Merck & Co. Inc.’s future outlook Kenilworth, NJ,usa
Merck & Co. , Inc.’s news release Kenilworth, NJ, United States (“Company”) contains “forward-looking statements” within the meaning of the Safe Harbor clause of the Private Securities Litigation Reform Act of 1995. These statements are based on the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. With respect to pipeline products, we cannot guarantee that the product will be approved by the required regulatory agencies or that the product will be commercially successful. If the underlying assumptions are found to be inaccurate, or if risks or uncertainties become apparent, the actual results may differ materially from those stated in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition. Common economic factors, including interest rate and exchange rate fluctuations. Impact of the worldwide outbreak of new coronavirus disease (COVID-19).Pharmaceutical industry regulations and the impact of medical law united states of america And internationally; a global trend towards curbing medical costs. Technological advances, new products and patents acquired by competitors. Challenges specific to new product development, such as obtaining regulatory approval. The company’s ability to accurately predict future market conditions. Manufacturing difficulties or delays; financial instability and sovereign risk in the international economy. Reliance on the effectiveness of company patents and other protections for innovative products. And exposure to proceedings, including patent proceedings, and / or regulatory measures.
We undertake no obligation to publicly update any forward-looking statement as a result of new information, future events, etc. Other factors that may cause results to differ materially from those stated in the forward-looking statements include the Company’s 2021 Annual Report on Form 10-K, and the Securities and Exchange Commission available at the SEC (SEC). It can be found in other company filings with the SEC). Internet site (www.sec.gov).
For the KEYTRUDA® product monograph, please visit https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf.
References
Source Merck Canada
For more information: Media Contact: Merck Canada Media Relations, 1-833-906-3725; Kelly Wyton, (647) 245-7625
..
