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Incyte Eyes Big Phase III IDO Expansion, NewLink Plans First Pivotal Trial

 
• By Emily Hayes

NewLink is hoping FDA will accept its plans to run one Phase III registrational study of its IDO pathway inhibitor indoximod with an anti-PD-1 agent in frontline melanoma; Incyte updates its Phase III plans for epacadostat.

First-quarter earnings calls on May 4provided an opportunity forIncyte Corp. to highlight the breadth of the multi-tumor registrational program for its leading IDO inhibitor epacadostat and for NewLink Genetics Corp.to share its plans to test its IDO pathway inhibitor indoximod in a pivotal melanoma study, which is set to kick off by the end of the year.

Incyte Corp.'s epacadostat is the most advanced candidate for one of the hottest new immunotherapy targets in development: indoleamine 2,3-dioxygenase 1 (IDO1). After early data were reported for the drug in combination with Merck & Co. Inc.'s PD-1 inhibitor Keytruda (pembrolizumab) in melanoma, the combination jumped straight to Phase III for that indication

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BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 
• By Alaric DeArment

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

Merck Set To Add Perioperative Head-And-Neck Cancer To Keytruda Label

 
• By Joseph Haas

With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.

Akeso Explains Ivonescimab Prelim OS Data After Investors’ Negative Reactions

 
• By Dexter Jie Yan

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Gilead Pipeline Progress Offsets Oncology Sales Slowdown

 
• By Alaric DeArment

Sales of the company’s approved cancer therapies were weaker or down, but Trodelvy is likely to see a label expansion and cell therapies are making progress.

More from Anticancer

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 
• By Alaric DeArment

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

 
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Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 
• By Jessica Merrill

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.