ISA Pharmaceuticals Announces Start of Phase 2 Combination Trial of ISA101b and Regeneron’s Cemiplimab in Oropharyngeal Cancer
- ISA101b and Cemiplimab studied in patients with platinum refractory HPV16-positive oropharyngeal cancer (OPC)
(firmenpresse) - Leiden, The Netherlands, January 21, 2019 REGN2810).
This double blind, placebo-controlled, randomized, phase 2 study (NCT03669718) will enroll approximately 164 patients with HPV16-positive oropharyngeal cancer (OPC), who have failed first-line chemotherapy. Patients will be randomly allocated on a 1:1 basis to the combination of cemiplimab/ISA101b or cemiplimab/placebo. In both study arms, patients will receive treatment in cycles of 3 weeks for up to 24 months. The primary efficacy objective of this trial is to assess whether the addition of ISA101b to cemiplimab will elicit a higher Overall Response Rate (ORR, as per RECIST 1.1 criteria) compared to cemiplimab plus placebo. Secondary endpoints include Progression Free Survival (PFS), Overall Survival (OS), as well as safety and tolerability of cemiplimab plus ISA101b (as compared to cemiplimab plus placebo). The study will be conducted at approximately 50 investigative sites in the USA and Europe.
ISA Pharmaceuticals for the treatment of various cancers.
Oropharyngeal cancer, a subtype of head-and-neck cancer, affects tissues of the throat (oropharynx), e.g. the base of the tongue, the tonsils, the soft palate, and the walls of the pharynx. Oropharyngeal cancers can be divided into two types: HPV-positive, which are related to human papillomavirus infection, and HPV-negative cancers, which are usually linked to alcohol or tobacco use.
___________________
1Massarelli et al. 2018 JAMA Oncology doi:10.1001/jamaoncol.2018.4051
###
Themen in dieser Pressemitteilung:
cancer
cancer-immunotherapy
cancer-vaccines
clinical-trial
oropharyngeal-cancer
regeneron
isa-pharmaceuticals
Unternehmensinformation / Kurzprofil:
About ISA Pharmaceuticals
ISA Pharmaceuticals B.V. is an immunotherapy company developing rationally designed, fully synthetic immunotherapeutics against cancer and persistent viral infections. The Company has built a proprietary immunotherapy platform based on the Synthetic Long Peptide (SLP®) concept and AMPLIVANT® technology and its next-generation manufacturing technology. SLP® immunotherapies are designed to fully harness and direct the body''s own defenses towards fighting the disease. In December 2017, ISA Pharmaceuticals closed a clinical immuno-oncology collaboration with Regeneron to advance its SLP® lead compound ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab / Libtayo® (REGN2810), a PD-1 (programmed cell death protein 1) antibody. In addition, ISA develops SLP® immunotherapies to advance novel treatment options for orphan indications.
For more information, please visit www.isa-pharma.com.
SLP® and AMPLIVANT® are registered trademarks in Europe.
Miranda Molenaar
ISA Pharmaceuticals B.V.
J.H. Oortweg 19
NL-2333 CH Leiden
The Netherlands
T: +31 71 33 22 310
F: +31 71 33 22 311
E: info(at)isa-pharma.com
Contact & Media Inquiries:
akampion
Dr. Ludger Wess Ines-Regina Buth
Managing Partner Managing Partner
Tel. +49 40 88 16 59 64 Tel. +49 30 23 63 27 68
info(at)akampion.com
Datum: 21.01.2019 - 04:13 Uhr
Sprache: Deutsch
News-ID 1545921
Anzahl Zeichen: 3685
contact information:
Contact person: Ines-Regina Buth
Town:
Berlin
Phone: +493023632768
Kategorie:
Pharmaceuticals & Biotech
Typ of Press Release: Success
type of sending: send
Date of sending: 21.01.2019
Anmerkungen:
Diese Pressemitteilung wurde bisher 612 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"ISA Pharmaceuticals Announces Start of Phase 2 Combination Trial of ISA101b and Regeneron’s Cemiplimab in Oropharyngeal Cancer
"
steht unter der journalistisch-redaktionellen Verantwortung von
akampion (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
