June 18, 2019 Merck known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This accelerated approval is based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first indication for Keytruda in SCLC.

"Keytruda is already an established treatment option for non-small cell lung cancer, and today’s approval in small cell lung cancer demonstrates our commitment to bringing forward new treatment options for patients with advanced, difficult-to-treat cancers," said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. "We look forward to continuing to advance important clinical research in small cell lung cancer."

Immune-mediated adverse reactions, which may be severe or fatal, can occur with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered, if appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman. For more information, see "Selected Important Safety Information" below.

"Small cell lung cancer, which accounts for 10 to 15% of all lung cancers, is often diagnosed at an advanced stage where the prognosis is very poor and there have historically been limited treatment options," said Dr. Patrick Ott, MD, PhD, clinical director, Center for Immuno-Oncology, Dana-Farber Cancer Institute. "The approval of Keytruda in small cell lung cancer provides an additional treatment option for patients based on the clinical response rates from KEYNOTE-158 and KEYNOTE-028."

About KEYNOTE-158 and KEYNOTE-028

The approval was based on pooled data from KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohort C1), two multicenter, multi-cohort, non-randomized, open-label trials evaluating Keytruda in patients with SCLC who had disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The trials excluded patients with autoimmune disease or a medical condition that required immunosuppression. Among the 83 patients enrolled in the trials and who were evaluated for efficacy, 64% received two prior lines of therapy and 36% received three or more lines of therapy; 60% received prior thoracic radiation therapy; 51% received prior radiation therapy to the brain.

Patients evaluated for efficacy received either Keytruda 200 mg intravenously every three weeks (n=64) or 10 mg/kg intravenously every two weeks (n=19). Treatment with Keytruda continued until documented disease progression, unacceptable toxicity or a maximum of 24 months. Patients with initial radiographic disease progression could receive additional doses of Keytruda during confirmation of progression unless disease progression was symptomatic, was rapidly progressive, required urgent intervention or occurred with a decline in performance status. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by BICR according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

Keytruda demonstrated an ORR of 19% (95% CI, 11-29), with a complete response rate of 2% and a partial response rate of 17%. Among the 16 responding patients, 94% had a DOR of six months or longer, 63% had a DOR of 12 months or longer and 56% had a DOR of 18 months or longer. Responses ranged from 4.1 to 35.8+ months.

Among the patients with SCLC enrolled in KEYNOTE-158 (cohort G) (n=107) and KEYNOTE-028 (cohort C1) (n=24) who were included in the safety analysis, the adverse reactions that occurred were similar to those occurring in patients with other solid tumors who received Keytruda as a single agent.

About Keytruda (pembrolizumab) Injection, 100mg

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient’s likelihood of benefiting from treatment with Keytruda, including exploring several different biomarkers.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.

About the Merck Access Program for Keytruda

At Merck, we are committed to supporting accessibility to our cancer medicines. Merck provides multiple programs to help appropriate patients who are prescribed Keytruda have access to our anti-PD-1 therapy. The Merck Access Program provides reimbursement support for patients receiving Keytruda, including information to help with out-of-pocket costs and co-pay assistance for eligible patients.

About Merck’s Patient Support Program for Keytruda

Merck is committed to helping provide patients and their caregivers support throughout their treatment with Keytruda. The KEY+YOU Patient Support Program provides a range of resources and support.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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