ImmunoGen Needs Another Phase III For Its ADC In Ovarian Cancer

The biotech’s hopes for an accelerated approval on subgroup data were dashed by the US FDA, but it will work with the agency to design a Phase III focused on highly FRα-positive patients.

business, education and office people concept - businessman or teacher with marker writing or drawing something on white blank board over concrete wall background from back - Image
ImmunoGen is back to the drawing board, needing a new Phase III for its ADC in ovarian cancer

After a disappointing data readout from the Phase III FORWARD 1 study of its antibody-drug conjugate (ADC) mirvetuximab soravtansine in ovarian cancer, ImmunoGen Inc. tried to placate investors with plans to seek an accelerated approval based on overall survival data in a patient subgroup. The company’s stock rebounded somewhat on that strategy, but fell again on 15 May when the Boston-area firm said the FDA declined to consider an accelerated approval.

ImmunoGen shares finished the trading day down 32% at $2.14 apiece, slightly below the stock’s $2.38 price on 1 March,...

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

More from Clinical Trials

Scholar Rock Shows Muscle-Building PoC In Obesity

 

The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.

Spyre Takes Aim At Roche And J&J In Inflammatory Diseases

 

The US firm was already looking to compete in ulcerative colitis, but now expands its ambitions by moving into rheumatoid arthritis as well.

Ireland’s Got Biopharma Talent To Keep Leading The Pack

 
• By 

The country’s life sciences investment head tells Scrip that it is business as usual for the sector despite the rumblings from across the Atlantic.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By 

Wales-based group launches with $140m series A.

More from R&D

Immuneering Could Partner Atebimetinib Or Go It Alone After Phase IIa Success

 

CEO Ben Zeskind said all options are on the table after atebimetinib showed impressive results in pancreatic cancer.

Enliven Raises $230m To Fund Scemblix Leukemia Challenger

 

The company believes its drug could eventually displace Novartis’s Scemblix in first-line chronic myeloid leukemia treatment, but for now is preparing for a second-/third-line pivotal study.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By 

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges