* Tecentriq works in all patients in second-line lung cancer
* Study shows 4.2 months survival benefit vs chemotherapy
* Drug may win U.S. approval in lung cancer this month
By Ben Hirschler
COPENHAGEN, Oct 9 Lung cancer patients on
Roche's immune system-boosting drug Tecentriq lived on
average 4.2 months longer than those taking chemotherapy in a
pivotal study, pressuring Bristol-Myers Squibb's
dominant position in the field.
The trial involved second-line patients, who have already
used chemotherapy, and it found the Roche drug worked even in
people with low or no levels of a protein called PD-L1, which is
often used to test suitability for immunotherapy.
The study results were presented at the annual European
Society of Medical Oncology congress on Sunday.
Bristol's Opdivo is currently the only immunotherapy drug
approved without a PD-L1 test for non-small cell lung cancer
(NSCLC), the most common form of the disease. Merck & Co's
Keytruda requires a test.
That has favoured Opdivo and fuelled its sales, but the
arrival of a rival with the same broad effectiveness now
promises increased competition.
U.S. regulators are due to decide whether to approve
Tecentriq in lung cancer by Oct. 19. The Roche drug is already
cleared for use in bladder cancer.
Tecentriq, Opdivo and Keytruda are the first of a highly
promising class of immunotherapy drugs that are revolutionising
cancer treatment and are tipped to generate huge sales. Lung
cancer, the biggest cancer killer globally, is the top
Analysts believe Tecentriq sales across all cancers will
reach $4 billion in 2021, according to consensus figures
compiled by Thomson Reuters.
In the 1,225-patient Roche study, the mean survival for
patients on Tecentriq was 13.8 months, which was 27 percent
better than the 9.6 months seen among those on docetaxel
The benefit of the new drug was greatest in patients with
high levels of PD-L1 but even in people with no PD-L1 expression
there was still a significant improvement.
Martin Reck of Germany's Lung Clinic Grosshansdorf said the
findings suggested doctors had a problem if they planned to use
a negative PD-L1 reading as a reason to exclude second-line
NSCLC patients from treatment.
Companies are also racing to prove that immunotherapy can
help in first-line NSCLC, where it would replace chemotherapy as
the initial drug given. Here, however, the idea of giving
immunotherapy to all patients has proved problematic, as
evidenced by the failure of a recent Bristol trial.
Roche has eight late-stage Phase III lung studies under way
evaluating Tecentriq alone or in combination with other
treatments in patients with early and advanced stages of lung
(Reporting by Ben Hirschler; Editing by Stephen Powell)