Expert Interview
Examining Coherus' Toripalimab in Nasopharyngeal Carcinoma before the April 29th PDUFA
Ticker(s): CHRSInstitution: UC Davis
- Medical Director of Thoracic Oncology at University of California, Davis
- Clinical interests include lung cancer and other thoracic cancers (mesothelioma and thymoma) as well as head and neck cancers
- Manages 4 patients with nasopharyngeal carcinoma
Please describe your clinical practice. Roughly how many patients with recurrent or metastatic nasopharyngeal carcinoma do you currently manage?
Added By: dami_adminWhat are your initial thoughts on the clinical trial data and scientific literature to date for toripalimab?
Added By: dami_adminOn a scale from 1-10 (10 being extremely excited), how would you rate your level of excitement for toripalimab?
Added By: dami_adminThoughts on whether Topiralimab will receive FDA Approval?
What factors may separate this from the recent LLY Sintilimab situation which resulted in a CRL in a different indication based on a trial exclusively in China?
Or do you see it as analogous?
Are you using Pembro or other PD-1's in this setting off-label currently? Either for NPC in combo with Chemo as frontline treatment, or reserving PD-1 in the second line?
If Topiralimab is approved, do you intend to use it for NPC, or continue using other PD-1s?
Do you see Topiralimab as a me-too PD-1 antibody and therefore would you use it off-label in other indications once it is approved for NPC?
Will having FDA approval make it easier to use Topiralimab for NPC than using Pembro off label? Or is Pembro already easily reimbursed and accessible for NPC?
In terms of market size, does company estimate of 2000-3000 new cases per year line up with your perception?
Added By: user1ae2bf5fDo you see this situation as analogous with Libtayo in CSCC - It was approved in a unique indication a few years ago after Opdivo and Pembro were already on the market for years for other indications, but it quickly got into the NCCN guidelines as the only approved agent, and it became the market leader /std of care in CSCC -
Can Topiralimab similarly achieve this in NPC despite the existence of these other agents?
If Coherus undercuts PD-1 pricing, will that change your view and how much you would anticipate using Topi in NPC? And for other indications?
Added By: user1ae2bf5fAre You Interested In These Questions?
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