Dive Brief:
- A combination drug regimen pairing Roche's checkpoint inhibitor Tecentriq with three older cancer therapies cut the risk of disease progression or death by nearly two fifths in previously untreated patients with a type of advanced lung cancer, when compared to the other drugs alone.
- Treatment with the novel drug cocktail doubled the percentage of patients whose cancers had not progressed after one year, a result that one physician called "very promising." Notably, study participants who received the Tecentriq combo saw a benefit regardless of PD-L1 expression.
- The positive study results boost the profile of Roche's Tecentriq, which currently trails rival immunotherapies from Merck & Co. and Bristol-Myers Squibb Co. in the lucrative lung cancer market. The Swiss pharma said it would submit the data to regulators for potential approval of the combo regimen as a frontline therapy.
Dive Insight:
Roche, along with other drugmakers in the immuno-oncology field, has bet on combination treatment as a way to expand the number of people who benefit from cancer immunotherapy.
The IMpower150 study, which tested the Tecentriq (atezolizumab) combo in frontline non-small cell lung cancer (NSCLC), is a key component of that strategy. Its success to date gives Roche a chance at eventually challenging the formidable position currently held by Merck's Keytruda (pembrolizumab) in previously untreated patients.
Roche had previously disclosed the trial met its primary endpoint of progression-free survival (PFS), but waited until the European Society of Medical Oncology's (ESMO) Immuno-Oncology Congress to reveal the more detailed findings.
According to the study results, patients who received Tecentriq and Roche's older drug Avastin (bevacizumab) plus chemotherapy had a 38% lower risk of disease worsening or death versus those who only were treated with Avastin and chemo.
At one year, 37% of patients on Tecentriq treatment had not experienced cancer progression compared to only 18% for those in the control arm.
"This is very, very promising," said Solange Peters, head of medical oncology at the Centre Hospitalier Universitaire Vaudois in Switzerland, in a Dec. 7 statement released by ESMO. "Doubling PFS at one year is something we have not seen with any targeted therapy in unselected patients to date."
Roche noted that early results on the study's co-primary endpoint of overall survival looked encouraging, but are not yet mature. Preliminary data will be presented later on Thursday at the Immuno Oncology Congress and further data is expected in the first half of next year.
IMpower150 was also designed to look at two different patient populations: an intention-to-treat analysis of randomized participants without an ALK or EGFR genetic mutation, and a subgroup of patients with a specific gene signature expression known as T-effector.
In that subgroup of patients, the Tecentriq combo extended PFS even further, reducing the relative risk of disease progression by 49%.
Both Roche and Merck's approach to combination treatment has looked first at pairing immmunotherapy with chemotherapy, based on a hypothesis that chemo's cytotoxic effect could enhance the effect of checkpoint inhibitors. Others, most notably Bristol-Myers and AstraZeneca plc, have focused on pairing immunotherapies together.
The rush to invest in combination therapies, however, masks a still-developing understanding of how immunotherapy works, and why only certain patients benefit. Results like Roche's suggest a way to improve response rates, but it's far from clear how different combinations might compare.
"In the next year, other trials will report results in frontline treatment-naive NSCLC patients using the combination of chemotherapy and immunotherapy or the combination of two immunotherapy drugs," said Peters. "The challenge will then be to judge which strategy is the best."