Trailing far behind Merck $MRK and Bristol-Myers Squibb $BMY, the leaders in the heated showdown for market supremacy in the PD-1/L1 commercial race, Roche is making its move in the key lung cancer market with a set of promising, progression-free survival data for a combination using Tecentriq.
Their closely watched Phase III IMpower150 study of a triple combo of Tecentriq, Avastin and chemo demonstrated a doubling in 12-month progression-free survival rates among a broad group of frontline lung cancer patients, setting the stage for a quick regulatory OK on both sides of the Atlantic.
“We have a real chance to be at the forefront here,” Roche CEO Severin Schwan told Reuters ahead of the data release. “Our ambition is to become a clear leader in the field of cancer immunotherapies.”
Comparing the triple against Avastin and chemo alone, researchers tracked a 38% reduction in the risk of disease progression, with the progression-free survival rate hitting 8.3 months for the triple against 6.8 months for the double. The hazard ratio (HR) was 0.62. In a subgroup of people defined by a biomarker (T-effector “Teff” gene signature expression Teff WT), the PFS hit an impressive 11.3 months for the triple.
Roche’s bottom line:
Importantly, a doubling of the 12-month landmark PFS rate was observed with the combination of Tecentriq and Avastin plus chemotherapy (37 percent) compared to Avastin plus chemotherapy (18 percent). The rate of tumor shrinkage (overall response rate, ORR), a secondary endpoint in the study, was higher in people treated with Tecentriq and Avastin plus chemotherapy compared with Avastin plus chemotherapy (64 percent vs. 48 percent).
“Doubling PFS (progression-free survival) at one year is something we have not seen with any targeted therapy in unselected patients to date,” Solange Peters, the head of Medical Oncology at the Centre Hospitalier Universitaire Vaudois in Lausanne, told the wire service.
To put the Roche data in perspective:
In a note from yesterday, UBS said a HR of .7 would be acceptable and anything close to or lower than .6 would be very good.
The HR was .62.
— Brad Loncar (@bradloncar) December 7, 2017
Not everyone was ready to call the play as entirely in Roche’s favor, though. EvercoreISI’s Uber Raffat rushed to Merck’s defense this morning. And Leerink’s Seamus Fernandez sees Merck remaining in the lead for lung cancer.
On the neutral to negative side, the benefit appears to be driven largely by biomarker positive patients – allowing for a wide range of questions including comparisons to MRK’s Keytruda as monotherapy in PDL1 high patients. However, the unique benefit of Tecentriq + Avastin in EGFR/ALK mutation positive patients may secure a place for this combination in 15-20% of patients globally as a second or third line treatment option.
Roche faces a big challenge on the checkpoint front. Top execs believe that Tecentriq is key to the company’s ability to replace revenue lost as its big three franchise drugs see generic competition build up and carve away revenue. But the pharma giant has also had its own setbacks with their PD-L1 therapy, with a stinging failure on bladder cancer that spurred fresh debate over the relative value of a PD-1 versus a PD-L1.
Today, they successfully countered that discussion, though this debate is far from over.
“This Tecentriq study is the first positive Phase III combination trial that showed a cancer immunotherapy reduced the risk of the disease getting worse when used as an initial treatment in a broad group of people with advanced non-squamous NSCLC,” said Sandra Horning, Roche’s chief medical officer. “The IMpower150 study represents an important advance in lung cancer treatment, and we will submit these results to regulatory authorities around the world to potentially bring a new standard of care to people living with this disease as soon as possible.”
Image: Roche CEO Severin Schwan Ap Images
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,500+ biopharma pros who read Endpoints News by email every day.Free Subscription