Merck, recognized as MSD outside the US and Canada, has unveiled significant progress with its phase 3 KEYLYNK-001 clinical trial. This study examined the efficacy of Keytruda (pembrolizumab) combined with chemotherapy, succeeded by maintenance therapy with Lynparza (olaparib), with or without bevacizumab, as an initial treatment strategy for individuals diagnosed with advanced epithelial ovarian cancer without BRCA mutations. The trial successfully reached its primary goal of Progression-Free Survival (PFS).
The conclusive analysis, overseen by an independent Data Monitoring Committee, revealed that the Keytruda plus Lynparza treatment arm exhibited a major statistical and clinical improvement in PFS compared to stand-alone chemotherapy.
While the trial didn’t achieve its secondary goal of Overall Survival (OS), the implications of Keytruda’s role within the intention-to-treat cohort remain undetermined. The observed safety profile aligns with findings from previous studies of these therapies individually. These findings will be showcased at a forthcoming medical conference and will undergo evaluation by regulatory bodies.
“An ongoing need exists for innovative treatment alternatives that can offer better outcomes for ovarian cancer patients,” stated Dr. Gursel Aktan, Merck Research Laboratories’ vice president in global clinical development. “KEYLYNK-001 marks the initial successful phase 3 trial of Keytruda combined with Lynparza, underscoring our commitment to research aimed at tackling the worldwide burden of women’s cancers.”
In the United States, Lynparza has received approval for three indications regarding ovarian cancer. These include maintenance for adult patients with detected or suspected harmful BRCA mutations in advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer showcasing a full or partial response to first-line platinum-based chemotherapy. Moreover, it is approved for use with bevacizumab in HRD-positive advanced epithelial ovarian cancer patients and for certain relapses treated with platinum-based chemotherapy, all contingent on FDA-approved diagnostic tools.
It’s important to note that Keytruda is not granted approval for ovarian cancer treatment.
The KEYLYNK-001 trial was a randomized, double-blind phase 3 study assessing Keytruda’s efficacy together with chemotherapy (paclitaxel and carboplatin) succeeded by Keytruda combined with Lynparza, possibly accompanied by bevacizumab, as a frontline therapy for BRCA non-mutated advanced epithelial ovarian cancer. Focused on PFS among patients whose tumors showcased PD-L1 involvement and the entire intention-to-treat demographic, secondary measures included OS alongside safety assessments. The trial enrolled 1,367 participants, randomized into groups receiving varying cycles of treatments, with options to switch medications in the case of significant adverse reactions or hypersensitivity.
Ovarian cancer originates often from the fallopian tubes or ovary’s outer surface. Globally recognized as the second most common gynecological malignancy, and the seventh most prevalent cancer among women, it affected roughly 324,603 individuals, leading to about 206,956 deaths in 2022. Projections suggest approximately 19,680 ovarian cancer diagnoses and roughly 12,740 related deaths in the US by 2024. Key treatment objectives aim to delay disease progression with aspirations for long-term remission.
Merck is broadening its research endeavors to enhance treatment choices for specific cancers affecting breast and gynecological regions to improve patient outcomes. With breast cancer topping the list of cancers among women globally and gynecological cancers trailing closely, Merck strives to offer more solutions to those battling these severe diseases. Engaging in more than 20 clinical trials impacting over 18,000 patients worldwide, Merck is at the forefront of pioneering research in the domain of women’s cancers, focusing on advancing care standards. Merck’s research spans trials for earlier-stage treatments and the exploration of novel methods and combinations for these therapies, as they work to create a comprehensive approach for the global challenge presented by women’s cancers.
Keytruda operates as an anti-programmed death receptor-1 (PD-1) therapy, enhancing the body’s immune system’s capacity to identify and combat tumour cells. As a humanized monoclonal antibody, Keytruda blocks PD-1 interactions, thereby activating vital T cells to target both cancerous and healthy cells.
Holding the industry’s most expansive immuno-oncology research framework, Merck is involved in over 1,600 Keytruda trials across numerous cancer types and treatment stages. Their extensive program aims to decode the role of Keytruda in various cancers and the predictive elements for treatment success, which includes the exploration of multiple biomarkers.
Lynparza stands as a pioneering PARP inhibitor, offering targeted interventions that leverage DNA repair pathway deficiencies to eliminate cancer cells more selectively. Its application includes broad clinical trials across diverse cancer types, with Merck striving to comprehend its impacts as both a standalone and combination treatment. Their independent collaboration has focused significantly on pairing Lynparza with Keytruda for optimized outcomes.