MERCK SERONO | MedPath

Dual Biopsy Approach Significantly Improves Survival in Advanced Cancer Patients

24 days ago

• Patients with advanced solid tumors showed 26% reduced risk of death when receiving tailored therapy based on concordant genomic alterations found in both tissue and liquid biopsies. • The phase II ROME trial demonstrated median overall survival of 11.05 months for patients with concordant biopsy results receiving targeted treatment versus 7.7 months with standard care. • Researchers found only 49% concordance between tissue and liquid biopsies, highlighting the complementary nature of both approaches and the need for integrated testing strategies in precision oncology.

Merck's Subcutaneous Pembrolizumab Shows Comparable Efficacy to IV KEYTRUDA with Significantly Reduced Administration Time

2 months ago

• Merck's subcutaneous pembrolizumab with berahyaluronidase alfa demonstrated noninferior pharmacokinetics compared to intravenous KEYTRUDA in a pivotal Phase 3 trial for metastatic non-small cell lung cancer treatment. • The subcutaneous formulation, administered in approximately two minutes versus standard IV infusion, reduced patient chair time by nearly 50% and healthcare professional active time by 45.7%, potentially improving treatment efficiency. • FDA review of the subcutaneous pembrolizumab application is underway with a target action date of September 23, 2025, which could make it the first subcutaneous checkpoint inhibitor available across all KEYTRUDA's approved solid tumor indications.

PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial

3 months ago

• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months. • The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk. • Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.

Global Biosimilars Market Set to Triple to $114 Billion by 2031, Driven by Patent Expirations and Cost Advantages

5 months ago

• The global biosimilars market is projected to grow from $36.01 billion in 2024 to $114.02 billion by 2031, representing a robust CAGR of 17.9%, fueled by increasing demand for cost-effective biologics. • Oncology biosimilars are emerging as a particularly strong segment, expected to reach $35.79 billion by 2034 with an 18.6% CAGR, as patent expirations of blockbuster cancer drugs create new market opportunities. • Regulatory support from agencies like FDA and EMA is accelerating biosimilar adoption, with recombinant human growth hormone and granulocyte colony-stimulating factor segments leading market growth across therapeutic areas.

FDA Approves Zolbetuximab for CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA approved zolbetuximab in combination with chemotherapy for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma on October 18, 2024. • Approval was based on the SPOTLIGHT and GLOW phase 3 trials, which demonstrated improved progression-free and overall survival with zolbetuximab plus chemotherapy. • Zolbetuximab targets CLDN18.2, a protein overexpressed in 50-80% of gastric cancers, offering a new targeted therapy option for previously non-targetable disease. • Routine CLDN18.2 testing is now crucial to identify patients who can benefit from zolbetuximab, establishing it as a standard of care in the first-line setting.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

6 months ago

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

Early Atezolizumab Switch After Vemurafenib/Cobimetinib Shows OS Improvement in BRAF V600-Positive Melanoma

8 months ago

• Switching to atezolizumab after a vemurafenib/cobimetinib run-in showed improved overall survival (OS) in BRAF V600-positive melanoma, though not statistically significant. • Median OS was 49.6 months with the early switch to atezolizumab, compared to 40.2 months with continuous targeted therapy. • Progression-free survival (PFS1) was longer with continuous targeted therapy, indicating better early tumor control with this approach. • No specific subgroups were identified that benefited from the targeted therapy run-in, suggesting limited predictive value.

Nivolumab Plus Chemotherapy Shows QOL Benefits and High Response in Urothelial Cancer Subsets

8 months ago

• The CheckMate 901 trial showed nivolumab plus chemotherapy maintained quality of life (QOL) compared to chemotherapy alone in urothelial carcinoma patients. • A subset analysis of CheckMate 901 revealed a high complete response rate (63%) in patients with lymph node-only metastatic urothelial cancer treated with nivolumab plus chemotherapy. • Early data on sacituzumab govitecan plus ipilimumab and nivolumab showed promising response rates but was halted due to unexpected immune myocarditis. • The combination of antibody-drug conjugates and immune checkpoint inhibitors remains a promising strategy but requires careful management of toxicities.

Nivolumab Plus Ipilimumab Demonstrates Superiority Over Chemotherapy in MSI-H/dMMR Metastatic Colorectal Cancer

a year ago

• The CheckMate 8HW trial demonstrated that nivolumab plus ipilimumab significantly improved progression-free survival compared to chemotherapy in previously untreated patients with MSI-H/dMMR metastatic colorectal cancer. • The immunotherapy combination reduced the risk of disease progression or death by 79% compared to chemotherapy, with a hazard ratio of 0.21 (P < .0001). • At 24 months, the progression-free survival rate was 72% with nivolumab/ipilimumab versus 14% with chemotherapy, indicating a substantial and sustained benefit. • The safety profile of nivolumab plus ipilimumab was distinct from chemotherapy, with fewer grade 3/4 treatment-related adverse events.

Merck Serono and Quintiles Forge Groundbreaking 5-Year Clinical Development Partnership

12 years ago

• Merck Serono and Quintiles establish an innovative five-year clinical development agreement, marking the first strategic collaboration of its kind between a biopharma company and services provider. • The partnership aims to accelerate therapeutic development across neurology, oncology, immuno-oncology, and immunology, with Quintiles becoming Merck's exclusive clinical development services provider. • Under the agreement, Merck Serono will lead strategic direction while Quintiles manages clinical trial execution, spanning from phase 1 through post-marketing studies.