Merck's Keytruda Demonstrates Strong Efficacy Across All Stages of Melanoma, Reinforcing Leadership in Immuno-Oncology

November 7, 2021 /BioonBIOON/ -- Merck & Co. recently announced at the Society for Melanoma Research (SMR) 2021 Congress new data evaluating the anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of melanoma, including: (1) exploratory 7-year follow-up data from the KEYNOTE-006 trial (NCT01866319), the pivotal trial supporting the indication of Keytruda for advanced melanoma; (2) the latest findings from the KEYNOTE-716 trial (NCT03553836), which evaluated Keytruda as adjuvant therapy for stage IIB or IICMelanomaAdult and pediatric (12 years of age and older) patients following complete resection.

Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at MSD Research Laboratories, stated: “The 7-year data for Keytruda in advanced melanoma represent a significant milestone in melanoma research. Just a decade ago, the median survival for patients with metastatic melanoma was less than one year, with only 10% of patients expected to survive beyond five years. We are honored to present these new long-term survival data for advanced disease, as well as stages IIB and IIC, at this year’s SMR 2021 Congress.”MelanomaLatest findings on adjuvant therapy.”

KEYNOTE-006 is an open-label, randomized, phase 3 study,compared Keytruda with Bristol Myers SquibbTumorImmunotherapy CTLA-4 inhibitor Yervoy (Chinese trade name: Yiwo, generic name: ipilimumab, ipilimumab/Yipilimuma) for the treatment of advancedMelanomaEfficacy and safety in patients.

Following completion of the KEYNOTE-006 trial, patients were eligible to transition to the KEYNOTE-587 trial for extended follow-up. A 7-year follow-up assessment was conducted for 210 patients from the KEYNOTE-006 trial (158 patients treated with Keytruda and 52 patients treated with Yervoy).

Long-term follow-up results showed,The median overall survival (OS) was 32.7 months in the Keytruda group and 15.9 months in the Yervoy group.（HR=0.70；[95%CI:0.58-0.83]）。The 7-year survival rates for the Keytruda and Yervoy groups were 37.8% and 25.3%, respectively.. The results of this exploratory analysis indicate that noOn BRAF Status, Prior BRAF Inhibitor (BRAFi) Treatment, and Adverse Prognostic Features (e.g., Elevated LDH Levels,TumorRegardless of factors such as large tumor size or the presence of brain metastases, Keytruda is associated with improved clinical outcomes.

These results representTo date, anti-PD-1/L1 therapy for advancedMelanomathe longest follow-up duration of the Phase 3 trial. No formal statistical testing of the data is planned.

KEYNOTE-716 is a multicenter, randomized, double-blind Phase IIIClinical Trial, currentlyComparison of Keytruda vs. PlaceboAdjuvant therapy for Stage IIB or IICMelanomaAdults and pediatric patients (12 years of age and older) following complete resectionEfficacy and safety in patients. The primary endpoint of this trial is recurrence-free survival (RFS).

as specified in the protocolIn the second interim analysis (IA2), adjuvant Keytruda continued to demonstrate a clinically meaningful improvement in RFS compared with placebo, with a 39% reduction in the risk of disease recurrence or death.(HR=0.61 [95% CI: 0.45-0.82]). As previously stated, the KEYNOTE-716 trial had already met the RFS primary endpoint at the first interim analysis (HR=0.65 [95% CI: 0.46-0.92]; p=0.00658); therefore, no statistical testing was performed at IA2. No new safety signals were observed.

At IA2, 14.8% (n=72/487) of patients receiving Keytruda experienced recurrence or death, compared with 23.5% (n=115/489) of patients receiving placebo.At the time of this analysis, the median RFS was not reached in either group.The distant recurrence rate among patients in the placebo group (12.3% [n=60/489]) was twice that among patients in the Keytruda group (6.4% [n=31/487]).

At IA2, the safety profile of Keytruda was consistent with previous reports. Treatment-related adverse events occurred in 82.8% (n=400/483) and 63.4% (n=308/486) of patients in the Keytruda and placebo groups, respectively. Grade 3–4 adverse events occurred in 17.0% (n=82/483) and 4.3% (n=21/486) of patients, respectively. Grade 3–4 immune-mediated adverse events and infusion reactions occurred in 10.1% (n=49/483) and 1.2% (n=6/486) of patients, respectively.

Based on data from the Phase 3 KEYNOTE-716 trial, the United StatesFDAIn early August this year, a supplemental Biologics License Application (sBLA) for Keytruda was accepted for the adjuvant treatment of Stage IIB or IIC.MelanomaAdult and pediatric (12 years of age and older) patients following complete resection.FDAPriority review was granted for this sBLA, and a Prescription Drug User Fee Act (PDUFA) target date has been set for December 4, 2021.

Many patients with stage II melanoma are at a high risk of recurrence after surgery.KEYNOTE-716 is the first Phase 3 study specifically evaluating adjuvant therapy for stage IIB and IIC melanoma., this is a field with a high unmet medical need.By advancing Keytruda immunotherapy intoMelanomaIn the early stage, following complete surgical resection, compared with observation alone, Keytruda has the potential to reduce the risk of recurrence in high-risk stage II patients.

Melanoma is the most serious type of skin cancer, characterized by the uncontrolled growth of pigment-producing cells. Over the past few decades, the incidence of melanoma has been rising, with nearly 325,000 newly diagnosed cases reported worldwide in 2020. In the United States, skin cancer is one of the most commonly diagnosed cancers, and melanoma accounts for the vast majority of skin cancer deaths. It is estimated that in 2021, the United States will have more than 106,000 newDiagnosisofMelanomacases, more than 7,000 people will die from the disease.

Keytruda belongs to the class of anti-PD-(L)1 tumor immunotherapies, which help detect and combat tumor cells by enhancing the capacity of the human immune system. Keytruda is an anti-PD-1 therapy that works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating what may affectTumorT lymphocytes of cells and healthy cells. Currently, Keytruda has become a cornerstone therapy for multiple types of cancer.

In the treatment of melanoma, based on the results of the EORTC132/KEYNOTE-054 trial, Keytruda has been approved in more than 90 countries worldwide and has been established as an important treatment option for the adjuvant therapy of patients with resected high-risk stage III melanoma. Additionally, Keytruda has also been approved for the treatment of unresectable or metastaticMelanomaPatient.

MSD has an extensive clinical development program evaluating Keytruda for early-stage disease. Currently, the company is conducting approximately 20 registrational studies. The KEYNOTE-716 study builds on prior data in fourTumorType(Melanoma, renal cell carcinoma, triple-negativeBreast cancer、Non-muscle-invasive bladder cancer) early-stage research results on the disease. (Bioon.com)

Original Source:New Research for KEYTRUDA (pembrolizumab) at Society for Melanoma Research (SMR) 2021 Congress Reinforces Merck’s Commitment to Patients With Melanoma Across Stages of Disease