Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Faster FDA Review A Possibility For Celldex’s Rintega After Phase II

This article was originally published in The Pink Sheet Daily

Executive Summary

Celldex presented positive data from a Phase II study testing the therapeutic cancer vaccine Rintega in patients with EGFRvIII-positive recurrent glioblastoma, including a survival advantage, at ASCO.

You may also be interested in...



Celldex At A Loss To Explain Why Brain Cancer Vaccine Rintega Failed Phase III

Rintega performed as usual in Phase III ACT IV study, but comparator arm Temodar was much better than in prior trials, for unknown reasons.

Celldex Couldn’t Sway FDA On Rintega

Although it yielded impressive survival data compared to standard of care, the Phase II ReACT study was not powered for efficacy, so FDA is requiring Phase III data as well despite the need in glioblastoma.

Opdivo/Yervoy Data Show Role For Checkpoint Combos; ASCO Debates Biomarkers

In Bristol’s CheckMate 067, PD-1 monotherapy performs as well as the PD-1/CTLA-4 combination in melanoma patients with higher expression of the PD-L1 biomarker, a finding that implies a personalized immunotherapy approach in the future.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS078556

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel