- A combination of Roche AG's immunotherapy Tecentriq with two older cancer drugs bested chemotherapy in extending progression-free survival (PFS) among previously untreated patients with squamous non-small cell lung cancer (NSCLC), the Swiss pharma announced March 20.
- Results from the Phase 3 study, known as IMpower 131, could position Tecentriq as the first checkpoint inhibitor to market for first-line treatment of squamous NSCLC, a subset that accounts for 25% to 30% of all NSCLC cases.
- Roche only disclosed topline results for the combination regimen's effect on PFS. At this point, no benefit in overall survival (OS) between the treatment and control groups was reported, but the study will continue to allow for further observation.
Tecentriq's success in IMpower 131 bolsters Roche's efforts to pair the checkpoint inhibitor with chemotherapy across the treatment landscape for lung cancer.
Currently a distant third in immuno-oncology behind rivals Merck & Co and Bristol-Myers Squibb Co., the Swiss pharma aims to make up ground by testing the ability of Tecentriq combinations to improve on current standards of care.
Positive results from an earlier study known as IMpower 150 were an important milestone in that strategy, proving the addition of Tecentriq to a regimen of three older cancer drugs cut the risk of disease progression or death by nearly two fifths in previously untreated NSCLC patients.
That study focused on the more common and less complicated non-squamous form of NSCLC, while IMpower 131 tested Tecentriq in squamous NSCLC. Squamous cells line the inside of airways within the lung. Cancers that develop from these cells are more commonly found in patients with a history of smoking, according to the American Cancer Society.
Merck & Co. has already established a formidable advantage in first-line treatment of non-squamous NSCLC. In the squamous subtype, however, Roche could secure an advantage.
"Roche has the potential to be first to market in this [first-line] squamous NSCLC setting," wrote Jefferies analyst Ian Hilliker in a March 20 note, indicating an approval in this setting might add between 1% and 3% to Roche's earnings per share over time.
In IMpower 131, Roche tested Tecentriq together with carboplatin and Abraxane (nab-paclitaxel) versus treatment with the two chemotherapies alone. The study, which enrolled 1,021 patients, is designed to assess the combination's effect on both PFS and OS.
Roche will share detailed trial results at an upcoming medical conference and plans to discuss the data with regulators.
Tecentriq currently holds approvals in metastatic bladder cancer and as a second-line treatment of advanced NSCLC.
Yet the drug widely trails Merck's Keytruda (pembrolizumab) and Bristol-Myers Opdivo (nivolumab), which have secured OKs from the Food and Drug Administration in a broader range of cancers.
Sales of Opdivo totaled nearly $5 billion in 2017, compared to $3.8 billion for Keytruda and about $500 million for Tecentriq.