1. Scrip
  2. >>Therapy Areas
  3. >>Anticancer
  4. >>Immuno-oncology

FDA Flags Lower Efficacy For Merck's Keytruda, Roche's Tecentriq In Frontline Bladder Cancer Trials

 
• By Emily Hayes

In patients with previously untreated metastatic bladder cancer with low PD-L1 expression, PD-1 drugs alone don't work as well as chemo.

Render illustration of Clinical Trial title on medical documents

The US FDA issued an alert on May 18 that said first-line monotherapy treatment with Merck & Co. Inc.'s Keytruda and Roche's Tecentriq in metastatic urothelial cancer (mUC) trials was linked with decreased survival in patients with low expression of the PD-L1 biomarker compared with chemotherapy, though this was not due to adverse events.

Keytruda (pembrolizumab), a PD-1 inhibitor, and Tecentriq (atezolizumab), a PD-L1 inhibitor, both were cleared under FDA's accelerated approval process for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Immuno-oncology

BMS’s Breyanzi Stands To Further Expand Broad Lymphoma Coverage

 
• By Alaric DeArment

The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.

Henlius CEO Details PD-L1 ADC’s Path To 1L Mono/Combo Therapy

 
• By Dexter Jie Yan

Henlius is investigating the optimum dose for its PD-L1-targeting antibody-drug conjugate HLX43 to support potential first-line use, its CEO explains to Scrip.

Is Zydus’s Agenus Deal Opportunistic Or Strategic?

 
• By Vibha Ravi

Will Zydus’s acquisition and licensing deal with Agenus turn out to be a strategic move towards building an oncology portfolio or an opportunistic one driven by a venture capital mindset?

ASCO: Kite’s Glioblastoma CAR-T Highlights Solid Tumor Progress

 
• By Alaric DeArment

The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.

More from Anticancer

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

In Brief: Starton Moves Low-Dose Lenalidomide To Phase IIa For Multiple Myeloma

 
• By Sushmita Panda

Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.