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

Dispatch Uses ‘Flare’ To Send CAR-Ts To Solid Tumors

 
• By Alaric DeArment

With $216m in initial funding, the newly launched company is aiming to develop a cell therapy-based universal immuno-oncology option for solid tumor indications.

Chinese Biotechs Sweep ADC Plus PD-(L)1/VEGF Bispecific Combos Into Phase II

 
• By Dexter Jie Yan

Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.

Sino Biopharm Scoops LaNova In Chinese Pharma’s Biggest Biotech Buyout So Far

 
• By Dexter Jie Yan

Sino Biopharm will pay almost $1bn to acquire what target LaNova’s CEO described as an “exploding” pipeline, which includes six clinical-stage candidates in the oncology area.

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 
• By Anju Ghangurde

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.

More from Anticancer

Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By Joseph Haas

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 
• By Alaric DeArment

The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms including Insilico, big pharmas J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?