- A flurry of Phase 3 data this year from Roche's immmunotherapy Tecentriq has so far proved insufficient to erase the lead of Merck & Co.'s rival Keytruda in first-line lung cancer, with the latest missed opportunity coming Thursday.
- In a study called IMpower 132, Tecentriq combined with Alimta and platinum chemotherapy extended progression-free survival compared to chemotherapy alone in patients with non-squamous non-small cell lung cancer (NSCLC). But the difference in overall survival between the two groups was not yet statistically significant, delaying Roche's shot at proving a survival benefit until sometime next year.
- That's important, because IMpower 132 most closely resembles Merck's Keynote-189 study, which in April demonstrated Keytruda plus Alimta and platinum chemotherapy cut the risk of death by a dramatic 51% versus chemo.
Although PD-1/PD-L1 inhibitors like Tecentriq (atezolizumab) have proven effective in a range of cancer types, competition has been fiercest in the large — and lucrative — lung cancer market.
There, Merck's Keytruda (pembrolizumab) has established a leading position in the first-line setting that's fueled the drug's run to the top of the immuno-oncology field.
Among patients with non-squamous forms of NSCLC, Keytruda remains the only checkpoint inhibitor approved as an initial treatment. Results from Keynote-189 and Keynote-042 have demonstrated the drug's survival benefit in all comers when combined, and in patients with high PD-L1 expression when given alone.
And Keynote-407 has shown Keytruda can help patients with squamous forms of NSCLC live longer, too.
Efforts by Bristol-Myers Squibb and Roche, Merck's closest competitors, to draw even have so far fallen short this year. Roche, in particular, has read out results from four studies in NSCLC, three of which tested the drug in patients with non-squamous disease.
Tecentriq trials in first-line non-small cell lung cancer (NSCLC)
|IMpower 150||1L non squamous NSCLC||Tecentriq + Avastin + carbo/tax||Avastin + carbo/tax||Positive PFS, OS|
|IMpower 131||1L squamous NSCLC||Tecentriq + Abraxane + carbo||Abraxane + carbo||Positive PFS|
|IMpower 130||1L non squamous NSCLC||Tecentriq + Abraxane + carbo||Abraxane + carbo||Positive PFS, OS|
|IMpower 132||1L non squamous NSCLC||Tecentriq + Alimta + cis or carbo||Alimta + cis or carbo||Positive PFS|
NOTE: Carbo = carboplatin; tax = paclitaxel; cis = cisiplatin. SOURCE: Roche, clinicaltrials.gov
But in IMpower 131, and now IMpower 132, combinations involving Tecentriq failed to show an overall survival OS benefit at the first interim readout. These trials could still eventually meet their OS goal, but the delay gives Merck a chance to extend its lead further.
"The competitor readouts have continued to solidify [Merck]'s leadership in [first-line] lung," wrote Evercore ISI analyst Umer Raffat in a July 19 note to clients.
Roche's results seemed to disappoint investors, as American Depositary Receipts of Roche common stock fell more than 1% in value Thursday morning.
The Swiss pharma isn't out of the running, though. Tecentriq's OS success in IMpower 150 and IMpower 130 should give investors some confidence. But in a competition against Merck, delays might cost as much as misses.