Clinical Research and Research Laboratories

Keytruda/Lenvima combo shows promise in hard-to-treat cancers

The Pharma Data

SEPTEMBER 21, 2020

“These new data from our LEAP clinical program show encouraging activity across several aggressive cancer types and expand our knowledge about the potential of KEYTRUDA plus LENVIMA to help a range of patients with these cancers,” said Scot Ebbinghaus, vice president, Clinical Research, Merck Research Laboratories.

Research Laboratories

Research Laboratories Laboratories Trials Therapies

Could Keytruda/Lenvima Combo Help Treat Advanced Renal Cell Carcinoma?

The Pharma Data

NOVEMBER 9, 2020

It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.”. “We

Research Laboratories

Research Laboratories Laboratories Treatment Therapies

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

AUGUST 31, 2021

“While the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We

FDA Approval

FDA Approval Treatment FDA Research Laboratories

BioSpace Movers & Shakers, Nov. 20

The Pharma Data

NOVEMBER 19, 2020

Previously, Baffa was Therapeutic Area Head of Oncology, Global Clinical Development for Shire. The company also announced the addition of Robin Patel to its clinical and scientific advisory board. HotSpot Therapeutics – Eva Jack was named COO of Boston-based HotSpot.

Laboratories

Laboratories Research Laboratories Science Organic Chemistry

Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab)

The Pharma Data

MARCH 30, 2021

“KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We

FDA Approval

FDA Approval Treatment FDA Therapies

BioSpace Movers & Shakers, Dec. 18

The Pharma Data

DECEMBER 17, 2020

Martin Carter Professor in Clinical Investigation and Head of the Laboratory of Investigative Dermatology at The Rockefeller University and Weinblatt is the co-director of Clinical Rheumatology at the Brigham and Women’s Hospital. He spent 27 years at Merck & Co. Immune Regulation – U.K.-based based Immune Regulation Ltd.

Small Molecule

Small Molecule Clinical Development Engineering Pharmaceuticals

Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type.

Laboratories

Laboratories Clinical Trials Protein Expression Pharmacokinetics

Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

The Pharma Data

AUGUST 15, 2021

“WELIREG is the first and only approved systemic therapy for patients with certain types of VHL-associated tumors, representing an important new treatment option for patients affected by this rare condition,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

Treatment

Treatment Disease Clinical Trials Therapies

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me

Alta Sciences

APRIL 4, 2025

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me pmjackson Fri, 04/04/2025 - 18:01 By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services. How Clinical Research Saved My Life I was born in 2000.

Clinical Research

Clinical Research Science Research Research Laboratories

KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery

The Pharma Data

APRIL 8, 2021

“Since its first approval in renal cell carcinoma nearly two years ago, KEYTRUDA has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Therapies

Therapies Disease Research Laboratories Treatment

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) as Single Agent for Certain Patients With MSI-H/dMMR Advanced Endometrial Carcinoma

The Pharma Data

AUGUST 10, 2021

“The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. Merck has the industry’s largest immuno-oncology clinical research program.

FDA

FDA Therapies Treatment Clinical Research

Merck Provides Update on KEYTRUDA® (pembrolizumab) Indication in Third-Line Gastric Cancer in the US

The Pharma Data

JULY 6, 2021

“While there remains an unmet need for heavily pre-treated patients with advanced gastric cancer, we recognize that the treatment landscape has evolved and we respect the FDA’s efforts to continually evaluate accelerated approvals,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

FDA Approval

FDA Approval FDA Treatment Therapies

Merck Receives Priority Review From FDA for New Drug Application for HIF-2? Inhibitor Belzutifan (MK-6482)

The Pharma Data

MARCH 16, 2021

In fact, up to 70% of patients with VHL develop renal cell carcinoma during their lifetime,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

FDA

FDA Disease Trials Drugs

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

The Pharma Data

JULY 8, 2021

KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

FDA Approval

FDA Approval FDA Treatment Therapies

Merck’s KEYTRUDA® (pembrolizumab) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

The Pharma Data

MARCH 17, 2021

“The European Commission’s approval of an expanded use of KEYTRUDA provides another option for adult and pediatric patients with classical Hodgkin lymphoma who have disease progression after earlier lines of therapy or relapse after transplantation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “We

Therapies

Therapies Treatment Disease Trials

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma

The Pharma Data

JUNE 29, 2021

“KEYTRUDA plus chemotherapy is the first anti-PD1 therapy approved in Europe in this first-line setting, allowing these patients to be treated with immunotherapy earlier in the course of their treatment,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

Therapies

Therapies Treatment Disease Clinical Research

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

The Pharma Data

JULY 15, 2021

“These highly anticipated event-free survival results in this TNBC population build upon earlier findings from the KEYNOTE-522 trial and further support the potential use of KEYTRUDA in these patients,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

Therapies

Therapies Treatment Trials FDA

Merck’s KEYTRUDA® (pembrolizumab) Given After Surgery Reduced the Risk of Disease Recurrence or Death by 32% Versus Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC)

The Pharma Data

JUNE 25, 2021

Merck has the industry’s largest immuno-oncology clinical research program. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Disease

Disease Therapies Treatment Medical Schools

Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy.

The Pharma Data

SEPTEMBER 7, 2021

“In China, esophageal and gastroesophageal junction cancers are leading causes of death, and there have been few treatment advances for patients over the past several decades,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

Treatment

Treatment Research Laboratories Packaging Laboratories

LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

The Pharma Data

JULY 22, 2021

“When compared to the chemotherapies used in this trial, this combination treatment regimen was proven to extend the lives of certain patients diagnosed with previously treated, advanced endometrial cancer,” said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories.

Therapies

Therapies Treatment Disease Trials

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

The Pharma Data

MARCH 23, 2021

“There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We

Treatment

Treatment FDA Approval FDA Therapies

Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3.

The Pharma Data

SEPTEMBER 1, 2021

If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”.

Laboratories

Laboratories Clinical Trials Virus Trials

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

Organoids and similar systems are incomplete models, which means they lack immune systems—often an essential part of what is being researched in biomedicine as pain and the immune system modulate each other in important ways. Work towards improving animal welfare is ongoing and certainly not limited to research laboratories.

Research

Research Engineering Disease Science

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) together With Chemotherapy surely Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative carcinoma Whose Tumors Express PD-L1 (CPS ?10)

The Pharma Data

SEPTEMBER 28, 2021

“Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. Merck has the industry’s largest immuno-oncology clinical research program.

Research Laboratories

Research Laboratories Clinical Research Treatment Disease

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

Merck has the industry’s largest immuno-oncology clinical research program. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Treatment

Treatment FDA Approval FDA Therapies

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.

Trials

Trials Clinical Trials International Production

Q&A: How a partnership between physicians and researchers aims to make cancer drugs safer

Broad Institute

NOVEMBER 6, 2024

When we launched the SIC service, Chloé had just joined MGH and the Broad to start her independent research laboratory, and when our department heads heard about our shared interest, they connected us on a “scientific blind date.”

Research

Research Immune Response Hospitals Therapies

Drug Discovery Digest

Keytruda/Lenvima combo shows promise in hard-to-treat cancers

Could Keytruda/Lenvima Combo Help Treat Advanced Renal Cell Carcinoma?

Trending Sources

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

BioSpace Movers & Shakers, Nov. 20

Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab)

BioSpace Movers & Shakers, Dec. 18

Informed Design of Bioanalytical PCR Assay Testing Parameters

Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me

KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) as Single Agent for Certain Patients With MSI-H/dMMR Advanced Endometrial Carcinoma

Merck Provides Update on KEYTRUDA® (pembrolizumab) Indication in Third-Line Gastric Cancer in the US

Merck Receives Priority Review From FDA for New Drug Application for HIF-2? Inhibitor Belzutifan (MK-6482)

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

Merck’s KEYTRUDA® (pembrolizumab) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

Merck’s KEYTRUDA® (pembrolizumab) Given After Surgery Reduced the Risk of Disease Recurrence or Death by 32% Versus Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC)

Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy.

LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3.

Raising Welfare for Lab Rodents

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) together With Chemotherapy surely Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative carcinoma Whose Tumors Express PD-L1 (CPS ?10)

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

Q&A: How a partnership between physicians and researchers aims to make cancer drugs safer

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