FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

KEYTRUDA Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions

KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC

Merck known as MSD outside the United States and Canada, moment blazoned that theU.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’santi-PD-1 remedy, for the adjuvant treatment of cases with renal cell melanoma (RCC) at intermediate-high or high threat of rush following nephrectomy, or following nephrectomy and resection of metastatic lesions. The blessing is grounded on data from the vital Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant enhancement in complaint-free survival (DFS), reducing the threat of complaint rush or death by 32 (HR = 0.68 (95 CI,0.53-0.87); p = 0.0010) compared to placebo. Median DFS has not been reached for either group.

“ Despite decades of exploration, limited adjuvant treatment options have been available for before- stage renal cell melanoma cases who are frequently at threat for rush. In KEYNOTE-564, pembrolizumab reduced the threat of complaint rush or death by 32, furnishing a promising new treatment option for certain cases at intermediate-high or high threat of rush,” saidDr. ToniK. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of drug, Harvard Medical School. “ With this FDA blessing, pembrolizumab may address a critical unmet treatment need and has the implicit to come a new standard of care in the adjuvant setting for meetly named cases.”

In RCC, Merck has a broad clinical development program exploring KEYTRUDA, as monotherapy or in combination, as well as other investigational products across multiple settings and stages of RCC, including adjuvant and advanced or metastatic complaint.

Data Supporting the Blessing

KEYTRUDA demonstrated a statistically significant enhancement in DFS in cases with RCC at intermediate-high or high threat of rush following nephrectomy, or following nephrectomy and resection of metastatic lesions compared with placebo (HR = 0.68 (95 CI,0.53-0.87); p = 0.0010). The trial will continue to assess overall survival ( Zilches) as a secondary outgrowth measure.
About Renal Cell Melanoma (RCC)

Renal cell melanoma is by far the most common type of order cancer; about nine out of 10 order cancer judgments are RCCs. Renal cell melanoma is about doubly as common in men than in women. Utmost cases of RCC are discovered apropos during imaging tests for other abdominal conditions. Worldwide, it’s estimated there were further than new cases of order cancer diagnosed and further than deaths from the complaint in 2020. In theU.S., it’s estimated there will be further than new cases of order cancer diagnosed and nearly deaths from the complaint in 2021.
About Merck’s Beforehand-Stage Cancer Clinical Program

Chancing cancer at an earlier stage may give cases a lesser chance of long- term survival. Numerous cancers are considered most treatable and potentially curable in their foremost stage of complaint. Structure on the strong understanding of the part of KEYTRUDA in latterly- stage cancers, Merck is studying KEYTRUDA in earlier complaint countries, with roughly 20 ongoing registrational studies across multiple types of cancer.
About KEYTRUDA ® (pembrolizumab) Injection, 100 mg
KEYTRUDA is ananti-programmed death receptor-1 (PD-1) remedy that works by adding the capability of the body’s vulnerable system to help descry and fight excrescence cells. KEYTRUDA is a humanized monoclonal antibody that blocks the commerce between PD-1 and its ligands, PD-L1 and PD-L2, thereby cranking T lymphocytes which may affect both excrescence cells and healthy cells.
Merck has the assiduity’s largest immuno-oncology clinical exploration program. There are presently further than trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the part of KEYTRUDA across cancers and the factors that may prognosticate a case’s liability of serving from treatment with KEYTRUDA, including exploring several different biomarkers.
About the Merck Access Program for KEYTRYDA

At Merck, we’re committed to supporting availability to our cancer drugs. Merck provides multiple programs to help applicable cases who are specified KEYTRUDA have access to ouranti-PD-1 remedy. The Merck Access Program provides payment support for cases entering KEYTRUDA, including information to help with out-of- fund costs andco-pay backing for eligible cases.
About Merck’s Case Support Program for KEYTRUDA

Merck is committed to helping give cases and their caregivers support throughout their treatment with KEYTRUDA. The KEY YOU Case Support Program provides a range of coffers and support.
Merck’s Focus on Cancer

Our thing is to restate advance wisdom into innovative oncology drugs to help people with cancer worldwide. At Merck, the eventuality to bring new stopgap to people with cancer drives our purpose and supporting availability to our cancer drugs is our commitment. As part of our focus on cancer, Merck is committed to exploring the eventuality of immuno-oncology with one of the largest development programs in the assiduity across further than 30 excrescence types. We also continue to strengthen our portfolio through strategic accessions and are prioritizing the development of several promising oncology campaigners with the eventuality to ameliorate the treatment of advanced cancers. For further information about our oncology clinical trials, visitwww.merck.com/clinicaltrials.
About Merck

For over 130 times, Merck, known as MSD outside the United States and Canada, has been contriving for life, bringing forward drugs and vaccines for numerous of the world’s most grueling conditions in pursuit of our charge to save and ameliorate lives. We demonstrate our commitment to cases and population health by adding access to health care through far- reaching programs, programs and hookups. Moment, Merck continues to be at the van of exploration to help and treat conditions that hang people and creatures – including cancer, contagious conditions similar as HIV and Ebola, and arising beast conditions – as we aspire to be the premier exploration-ferocious biopharmaceutical company in the world.

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