Headline:
Merck’s investigational treatment, zilovertamab vedotin, in conjunction with the standard R-CHP therapy, delivers a complete response rate (CRR) of 100% at a 1.75 mg/kg dose in a Phase 2 trial targeting previously untreated diffuse large B-cell lymphoma (DLBCL).
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Merck, operating as MSD outside North America, has revealed initial findings from its Phase 2 waveLINE-007 clinical trial. This trial evaluates zilovertamab vedotin, Merck’s in-development antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in tandem with cyclophosphamide, doxorubicin, prednisone, and rituximab (R-CHP) for those newly diagnosed with diffuse large B-cell lymphoma (DLBCL).
At a predetermined analysis, the combination of zilovertamab vedotin with R-CHP recorded a 100% complete response (CR) rate among patients administered a 1.75 mg/kg dosage. This has prompted the study to recommend 1.75 mg/kg as the suggested dose for Phase 3 assessments. These findings were unveiled today in an oral presentation at the 66th Annual Meeting of the American Society of Hematology (ASH).
“New options for front-line treatment are necessary to aid DLBCL patients, as approximately 40% unfortunately face relapse or refractory conditions after their initial standard care treatment,” remarked Dr. Muhit Ozcan, the study’s chief investigator from Ankara University School of Medicine. “The phase 2 waveLINE-007 trial presents encouraging data, supporting further investigation into first-line treatments for a broader patient demographic, addressing a critical unmet patient need.”
“We are thrilled with the preliminary, affirmative outcomes from the waveLINE-007 trial, showcasing zilovertamab vedotin’s outstanding response rate and safety when combined with the standard treatment,” noted Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories. “We are eager to expand our exploration of this ROR1-directed ADC, which promises efficacy across numerous blood cancers.
At the 66th ASH congress, Merck is presenting findings from over 20 abstracts related to various blood cancers, showcasing a diverse array of investigational assets from its hematology pipeline.
WaveLINE-007 is a non-randomized, open-label phase 2 trial investigating zilovertamab vedotin (MK-2140) along with R-CHP in untreated DLBCL patients. It evaluates safety and complete response rates using the Lugano Response Criteria. Secondary goals include measuring objective response rate (ORR) and response duration. With data cut-off, 36 patients were enrolled for intravenous 21-day cycle treatment up to eight cycles, spread across three dosage groups. The 1.75 mg/kg group (n=15) completed the trial; all 15 finished treatment. Among the other groups, the 2.0 mg/kg group had 14 of 15 complete, while the 2.25 mg/kg group saw 5 of 6 complete.
Efficacy results indicated that a complete response was attained in all patients receiving 1.75 mg/kg and 2.25 mg/kg doses, and 93.3% of patients on the 2.0 mg/kg dose in combination with R-CHP.
Adverse events related to treatment appeared in 11% of patients, with serious Grade 3-4 events including neutropenia, nausea, anemia, and diarrhea occurring in 58% of participants.
Lymphoma begins in the body’s immune system, with DLBCL being the most prevalent non-Hodgkin lymphoma variant. It tends to grow rapidly, leading to swollen lymph nodes and potential spread. Worldwide, DLBCL accounts for roughly 25-30% of non-Hodgkin lymphomas, with approximately 25,000 new cases annually in the U.S. The survival rates for DLBCL range from 60-70% over five years.
Zilovertamab vedotin, by targeting ROR1, aims to treat multiple blood malignancies effectively. Merck dedicates itself to exploring this through an extensive waveLINE clinical trial series across different B-cell cancers. This comprehensive program searches for innovative cancer solutions, with the potential to modify patient care landscapes and meet unmet needs efficiently.
Merck’s ongoing mission in oncology is rooted in extensive research initiatives examining diverse investigational therapies across various cancer types. Their dedication fuels efforts to surge forward in treating and understanding diverse cancers, aspiring for a future where patients benefit from groundbreaking scientific advancements. The company’s efforts are geared towards ensuring equitable access to high-quality oncology care and embracing novel mechanisms to address longstanding gaps in patient treatment.