RAHWAY - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the non-registrational Phase 2 KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA), Merck's anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy.

These results are being presented today during a poster session at the 2023 European Society of Medical Oncology (ESMO) Immuno-Oncology (I-O) Annual Congress (abstract #121P).

Data presented at ESMO I-O showed that vibostolimab/pembrolizumab plus docetaxel extended median progression-free survival (PFS) by 2.4 months compared to those treated with docetaxel alone, though the results did not reach statistical significance (5.6 months vs. 3.2 months; HR=0.77 [95% CI, 0.53-1.13]; p=0.0910). Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).

'This study was designed to evaluate a coformulation of vibostolimab and pembrolizumab in a population of patients who are heavily pre-treated and have progressed following treatment with standard of care therapies, often leaving them with limited treatment options and a poor prognosis,' said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. 'We will leverage our evolving understanding of novel combinations and coformulations to help inform our comprehensive research program evaluating this coformulation across a wide range of tumor types.'

Data from key secondary endpoints, including overall survival (OS), overall response rate (ORR) and duration of response (DOR) were also presented. Vibostolimab/pembrolizumab plus docetaxel improved OS compared with docetaxel alone, though these results did not reach statistical significance (HR=0.76 [95% CI, 0.50-1.15]). Vibostolimab/pembrolizumab alone did not show an improvement in OS compared to docetaxel alone (HR=1.05 [95% CI, 0.70-1.58). The median OS for vibostolimab/pembrolizumab plus docetaxel was 10.2 months (95% CI, 8.6-14.9), 7.5 months (95% CI, 5.2-13.4) for vibostolimab/pembrolizumab alone and 8.8 months (95% CI, 6.4-11.1) for docetaxel. The ORR for patients receiving vibostolimab/pembrolizumab plus docetaxel was 29.9% (95% CI, 20.5-40.6), 6.0% (95% CI, 2.0-13.5) for vibostolimab/pembrolizumab alone and 15.3% (95% CI, 8.4-24.7) for docetaxel. Median DOR was 6.5 months (range, 2.1+ to 15.4+ months) for the vibostolimab/pembrolizumab plus docetaxel arm. Median DOR was not reached for the vibostolimab/pembrolizumab arm (range, 2.6+ to 6.2+ months) and for the docetaxel arm (range, 1.6 to 11.1+ months).

The safety profile of vibostolimab/pembrolizumab was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals observed. Immune-mediated adverse events and infusion reactions occurred in 29.4% of patients who received vibostolimab/pembrolizumab plus docetaxel, 20.5% of those who received vibostolimab/pembrolizumab alone and 12% of those who received docetaxel alone. There were four treatment-related deaths in the vibostolimab/pembrolizumab plus docetaxel arm of the study, and one in each of the vibostolimab/pembrolizumab and docetaxel only arms. In the vibostolimab/pembrolizumab only arm of the study, there was a lower incidence of treatment-related adverse events (TRAEs) of any grade compared to the docetaxel only arm (60.2% vs. 89.2%), and 96.5% of patients in the vibostolimab/pembrolizumab plus docetaxel arm had TRAEs. The most common severe (grade 3-5) TRAEs in the study were neutropenia (16.5%), anemia (7.1%) and asthenia (4.7%) for treatment with vibostolimab/pembrolizumab plus docetaxel; asthenia (2.4%) and diarrhea (2.4%) for vibostolimab/pembrolizumab alone and neutropenia (14.5%) and anemia (6.0%) for docetaxel alone.

Vibostolimab is Merck's investigational anti-TIGIT antibody that restores antitumor activity by blocking the TIGIT receptor from binding to its ligands (CD112 and CD155), thereby activating T lymphocytes that help destroy tumor cells. Merck has an extensive clinical development program evaluating the safety and efficacy of the vibostolimab/pembrolizumab coformulation alone and in combination with other agents in over 4,000 patients. Ongoing Phase 3 studies in lung cancer include KeyVibe-003, KeyVibe-006, KeyVibe-007 and KeyVibe-008, as well as KeyVibe-010 in melanoma.

About KeyVibe-002

KeyVibe-002 is a randomized, partially blind Phase 2 trial (ClinicalTrials.gov, NCT04725188) evaluating vibostolimab/pembrolizumab, a coformulation of vibostolimab and pembrolizumab, with or without docetaxel versus placebo plus docetaxel in patients with metastatic NSCLC with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. The trial's primary endpoint is PFS, as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key secondary endpoints include OS and ORR, as assessed by BICR per RECIST v1.1. The study enrolled 255 patients who were randomly assigned in three separate study arms (1:1:1) to receive either: Arm 1 (Blinded): Vibostolimab/pembrolizumab (pembrolizumab 200 mg plus vibostolimab 200 mg/20 mL intravenously [IV] every 3 three weeks [Q3W] until a discontinuation criterion is met or completion of 35 cycles) plus docetaxel (75 mg/m2 IV Q3W until a discontinuation criterion is met or as per approved local label); or Arm 2 (Open-label): Vibostolimab/pembrolizumab (pembrolizumab 200 mg plus vibostolimab 200 mg/20 mL IV Q3W until a discontinuation criterion is met or completion of 35 cycles); or Arm 3 (Placebo-blinded): Placebo (saline IV Q3W) plus docetaxel (75 mg/m2 IV Q3W until a discontinuation criterion is met or as per approved local label).

KeyVibe-002, a non-registrational study, was designed with two primary objectives: 1) to evaluate the efficacy of vibostolimab/pembrolizumab alone compared with docetaxel, a standard of care and 2) in a blinded assessment, evaluate the efficacy of adding vibostolimab/pembrolizumab to docetaxel, compared with docetaxel alone.

About lung cancer

Lung cancer is the leading cause of cancer death worldwide. In 2020 alone, there were more than 2.2 million new cases and approximately 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 81% of all cases. In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 26.2%, which is a 22% improvement over the last five years. Improved survival rates are due, in part, to advances in diagnostic and surgical procedures, as well as the introduction of new therapies. However, screening, early detection and improving treatment rates remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced. Only 4.5% of people in the U.S. who are eligible were screened for lung cancer in 2022.

About Merck's research in lung cancer

Merck is advancing research aimed at transforming the way lung cancer is treated, with a goal of improving outcomes for patients affected by this deadly disease. Through nearly 200 clinical trials evaluating more than 36,000 patients around the world, Merck is at the forefront of lung cancer research. In NSCLC, KEYTRUDA has six approved U.S. indications and is approved for advanced disease in more than 95 countries. Among Merck's research efforts are trials focused on evaluating KEYTRUDA in earlier stages of lung cancer as well as identifying new combinations and coformulations with KEYTRUDA.

About vibostolimab

Vibostolimab is an investigational humanized anti-TIGIT antibody discovered and developed by Merck. Vibostolimab restores antitumor activity by blocking the TIGIT receptor from binding to its ligands (CD112 and CD155), thereby activating T lymphocytes that help destroy tumor cells. Vibostolimab/pembrolizumab is a coformulation of both vibostolimab and pembrolizumab and is being evaluated in a wide range of cancers, including lung, other solid tumors and blood cancers.

About KEYTRUDA (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (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 1,600 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 benefitting 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 Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

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