Sector News

Phase 3 trial of Transgene’s oncolytic virus halted for futility

August 5, 2019
Life sciences

A phase 3 liver cancer trial of Transgene and SillaJen’s oncolytic virus has been stopped early for futility. The setback sent the share prices of the companies downward and added to doubts about the effectiveness of oncolytic viruses.

Transgene’s partner, SillaJen, moved Pexa-Vec into phase 3 on the strength of data from a 30-patient study that linked the higher dose of the oncolytic virus to a median overall survival of 14.1 months. That is longer than the 10.7 months on the U.S. label of Bayer’s Nexavar, raising hopes that Pexa-Vec could improve on current treatment options.

The latest update quashes those hopes. Neither SillaJen nor Transgene have shared data from the trial, but whatever the independent data committee saw at the interim review was bad enough to prompt a recommendation that the study is stopped for futility.

SillaJen designed the 600-subject trial to show whether giving Pexa-Vec to first-line liver cancer patients before starting them on Nexavar could improve overall survival over the Bayer drug alone. The data committee decided that, on the basis of interim data, Pexa-Vec was unlikely to drive the desired improvement in overall survival.

There were signs ahead of the update that Pexa-Vec may struggle to beat Nexavar in a larger clinical trial. While the Nexavar label carries a median overall survival of 10.7 months, the drug recorded a figure of 12.3 months in a more recent head-to-head against Merck’s Lenvima. Given the chance Pexa-Vec may struggle to achieve a 14.1-month overall survival when tested in more patients, the data on Nexavar suggested the oncolytic virus may fail to beat Bayer’s drug.

Shares in Transgene fell about 19% in the immediate aftermath of the news. The failure is a bigger deal for SillaJen, which had gained a $3 billion market cap largely on the potential of Pexa-Vec. Shares in SillaJen fell 30% following the news.

The failure could have implications beyond Transgene and SillaJen. Leading drug developers such as Merck and Johnson & Johnson have piled into the oncolytic virus market over the past two years, in part because of the potential for the modality to turn cold tumors hot. But there are limited clinical data to support the use of oncolytic viruses.

By: Nick Paul Taylor

Source: Fierce Biotech

comments closed

Related News

January 29, 2023

Colorcon, Inc. signs Put agreement with intent to acquire controlled atmosphere packaging specialist Airnov Healthcare Packaging

Life sciences

Airnov provides critical healthcare industries with high-quality, controlled atmosphere packaging, to protect their products from moisture and oxygen. The business has manufacturing facilities in the USA, France, China and India and employs around 700 people.

January 29, 2023

Takeda pledges up to $1.13B for rights to Hutchmed’s cancer drug fruquintinib outside of China

Life sciences

Takeda of Japan has partnered with Hong Kong-based Hutchmed, gaining the commercial rights to colorectal cancer drug fruquintinib outside of China for $400 million up front, plus $730 million in potential milestone payments. Takeda also will help develop fruquintinib, which can be applied to subtypes of refractory metastatic colorectal cancer, regardless of biomarker status, the companies said.

January 29, 2023

Vir taps Bayer dealmaker Marianne De Backer as its next CEO

Life sciences

On April 3, Scangos, who’s been chief executive officer at Vir since the start of 2017, will hand over the reins to Marianne De Backer, Ph.D. De Backer comes over from Bayer, where she currently heads up pharmaceutical strategy, business development and licensing. Alongside her CEO appointment, De Backer is set to join Vir’s board of directors, the company said Wednesday.

How can we help you?

We're easy to reach