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Merck & Co.’s Keytruda/Inlyta Combo Invades Kidney Cancer Territory

 
• By Alexandra Shimmings

Merck & Co.’s IO powerhouse Keytruda has trumped Bavencio’s recent Inlyta combo PFS win in kidney cancer, with a OS and PFS combo hit of its own. But the field is getting increasingly crowded. 

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Merck & Co. Is Marching On Another New Indication

PD-1/L1 competition is heating up in the new battleground of kidney cancer, as Merck & Co. Inc. announced its Keytruda (pembrolizumab) in combination with Pfizer Inc.’s tyrosine kinase inhibitor Inlyta (axitinib) has hit both overall and progression-free survival endpoints in the Phase III KEYNOTE-426 study in first-line advanced/metastatic renal cell carcinoma.

An interim analysis has revealed statistically significant and clinically meaningful improvements in OS and PFS, compared to sunitinib monotherapy, with...

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Summit Fails To Reassure On Ivonescimab’s US Approvability

 
• By Andrew McConaghie

The global HARMONi study has failed to hit its overall survival endpoint, and discrepancies between China and Western results persist, raising doubts over its efficacy in the broader population.

Chinese Drug Makers Progress HER2 ADCs Amid Enhertu Dominance

 
• By Dexter Jie Yan

A total of seven Chinese fast-followers of Enhertu are chasing the global blockbuster for a share of China’s market for HER2-targeting antibody-drug conjugates.

Genmab/AbbVie’s Epkinly Could Get Competitive Edge With Outpatient Option

 
• By Alaric DeArment

Phase II data showed it is feasible to give the CD20xCD3-targeting bispecific in the outpatient setting of DLBCL, while its current label calls for hospitalization.

DualityBio Eyes 1L Use For ADC Combos With BioNTech’s Bispecific

 
• By Dexter Jie Yan

Duality is fast-tracking the development of three of its ADC candidates in combination with partner BioNTech's BNT327, an anti-PD-L1/VEGF-A bispecific antibody, in four studies, with certain cohorts evaluating first-line use in various cancers.

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Revolution’s Daraxonrasib Data Bolster Phase III Case Amid RAS Cancer Push

 
• By Alaric DeArment

The company announced positive monotherapy and chemotherapy-combination data for the RAS(ON) inhibitor in first-line pancreatic ductal adenocarcinoma.

For PMV Pharma, Ovarian Cancer Is First Big Stop On Rezatapopt’s Regulatory Journey

 
• By Alaric DeArment

PMV announced positive data from its Phase II trial in multiple TP53 Y220C-mutant solid tumors, with the second-line ovarian cancer opportunity worth up to $630m.

BioNTech/BMS Novel Bispecific Global Study Consistent With China-Only Results

 
• By Sushmita Panda

Interim Phase II data showed a 76% response rate with pumitamig plus chemo in first-line extensive-stage small-cell lung cancer, largely in line with data from an earlier China-only trial. Analysts say more mature outcomes data will be key as a Phase III trial advances.