Regulatory Index News: 08/02/2018

Welcome to your Regulatory Index News update today. Take a read here for your update on the recent regulatory developments.

Bristol-Myers' Opdivo-Yervoy combination beats chemo on PFS in lung cancer

BMS have succeeded in a Phase 3 trial (Checkmate-227) at proving a combination of their PD-1 checkpoint inhibitor Opdivo and their CTLA4 drug Yervoy, decreases the disease progression in previously untreated lung cancer patients with a high tumor mutation burden. On top of this, the trial has allowed the identification of the tumor mutation burden (TMB) biomarker which potentially predicts the response to immunotherapy drugs. The trial is still however continuing to determine the effect of the combination treatment to patient survival and this finding of increased progression free survival (PFS) has raised confidence of a positive result. There are however reservations regarding safety profile as in previous trials, safety issues somewhat negated the increased PFS benefit when analysing the overall survival of the patients. Please click here to read more from a FiercePharma article.

FDA approval for Gilead’s Biktarvy

The combination treatment, Biktarvy, has been approved in the US for treatment of HIV as a once-daily tablet that combines the investigational integrase strand transfer inhibitor bictegravir with the marketed Descovy. This approval was driven from the results of four Phase 3 trails which showed non-inferiority to ViiV healthcare’s dolutegravir at 48 weeks, with high rates of virologic suppression and no treatment-emergent resistance over 48 weeks. Three of these ongoing studies are analysing the efficacy and safety of the treatment compared to triple-therapy regimens containing dolutegravir. The other is studying whether switching virologically suppressed patients to Biktarvy against continuing a suppressive regimen. Whilst this is a big win for Gilead, ViiV healthcare, have filed a patent infringement suit against Gilead over bictegravir in the US and Canada. Please click here for further details from a PharmTimes article.

Allergan’s Phase 3 success for its anti-CGRP migraine drug

The first of two pivotal Phase 3 trials for Allergan’s ubrogepant migraine drug has met its key goal where both doses have shown a statistically significant greater percentage of pain freedom at two hours after initial dose versus placebo patients. The trial also found that the most bothersome migraine-associated symptoms are statistically significantly reduced after two hours, compared with placebo. Additionally, the treatment was found well-tolerated with a safety profile similar to that of placebo, and the most common side effects reported in less than 5% of cases. The full results of this trial are to be displayed at scientific meetings throughout 2018. Allergan have stated that they anticipate a 2019 filing for a New Drug Application (NDA). If you would like to read more, please click here for a PharmaTimes article.



Max Lymbery

Date Published

08th February 2018

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