- Adding Roche's Tecentriq to a chemotherapy regimen helped reduce the risk of disease progression or death for patients with an advanced type of lung cancer, according to data presented Saturday at the American Society of Clinical Oncology's annual meeting.
- In the IMpower131 trial, which enrolled participants with stage four squamous non-small cell lung cancer, the risk was 29% lower for those treated with Tecentriq plus carboplatin and nab-paclitaxel compared to those receiving just chemo. A third arm in the study paired Roche's medicine with a different kind of chemo — carboplatin and paclitaxel — but data there "are not yet available," according to an ASCO release.
- Of the two arms for which researchers did present data, median progression free survival was 6.3 months for patients treated with Tecentriq and chemo versus 5.6 months for patients treated with chemo alone. Median overall survival wasn't significantly different between the groups in this interim analysis.
As immuno-oncology drugmakers continue jostling for larger shares of the highly competitive NSCLC market, they've found major inroads can be made by having clinical data that shows their drugs are superior for a specific subpopulation. Merck has achieved enormous success, for instance, with its decision to first get Keytruda (pembrolizumab) approved for lung cancer patients with higher levels of a biomarker called PD-L1.
For Roche, such a strategy may prove vital for closing the gap between Tecentriq (atezolizumab) and market leaders Keytruda and Bristol-Myers Squibb's Opdivo (nivolumab). Last year, Opdivo raked in nearly $5 billion while Keytruda fetched $3.8 billion.
Merck's drug holds an important edge over Bristol-Myers' and Roche's, in that it already has two approvals in the first-line NSCLC setting. However, in previously untreated patients who don't express high-levels of PD-L1, Keytruda currently only carries an indication to treat non-squamous patients in combination with chemo.
About 25% to 30% of all NSCLC cases are characterized as squamous, meaning tumors develop from a type of cell that lines the inside of airways in the lungs. It's generally considered to be tougher to treat, and has seen fewer advances in treatment options, according a statement from lead study author Robert Jotte.
Squamous NSCLC could represent an opportunity for Roche, but it'll have to deliver. Merck has in-hand results from its KEYNOTE-407 study, which found Keytruda plus chemo resulted in significantly longer OS and PFS than chemo alone in squamous NSCLC.
Fresh data presented Sunday showed the Keytruda combo cut the risk of dying by 36% over chemotherapy. Notably, the survival benefit held up across PD-L1 expression.
While IMpower-131 could still eventually show an OS advantage, that Merck already holds this kinda of data likely means tough competition for Tecentriq.
The ASCO statement noted that IMpower-131's OS data "are not yet mature," and that researchers anticipate another analysis to come sometime in 2018.
IMpower131 enrolled just north of 1,000 patients, with 343 in the Tecentriq plus carboplatin and nab-paclitaxel arm and 340 in the carboplatin and nab-paclitaxel arm. While investigators did test patients' tumors for PD-L1 expression, they didn't exclude anyone based on expression level. Patients with EGFR or ALK gene mutations were given targeted therapies before beginning treatment in the trial.
At 12 months, cancer in nearly a quarter of Tecentriq-treated patients hadn't worsened compared to 12% of those receiving chemo alone.
"Although the difference between treatment groups is modest, a statistically significant improvement shows that, overall, people with advanced squamous lung cancer can benefit when immunotherapy is added to standard treatment, according to the authors," ASCO said in its June 2 statement.
IMpower-131 is the third study in which Tecentriq has demonstrated a benefit in NSCLC on either PFS or OS when paired with chemo. Taken together with Merck's success combining Keytruda with chemo agents, it's further evidence that chemotherapy can help make immunotherapy more effective.
Editor's note: This article has been updated to reflect the data Merck presented June 3 from Keynote-407.