After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa.
Alecensa, compared with chemotherapy, reduced the risk of tumor recurrence or death when used after surgery in certain non-small cell lung cancer patients, Roche said Friday. The patients had ALK-positive, stage 1b to 3a tumors that were completely resected before taking Alecensa.
The positive readout, from the ALINA trial, makes Alecensa the first ALK inhibitor to show a benefit in early-stage NSCLC in a phase 3 trial, Roche noted.
Data on patient survival remain immature. But the Swiss pharma said it’ll submit the results to the FDA and the European Medicines Agency for a potential label expansion.
“If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Roche’s chief medical officer Levi Garraway, M.D. Ph.D., said in a statement Friday.
Before Alecensa’s readout in the adjuvant treatment setting, Roche’s Tecentriq, used alongside chemo, became the first medicine in the PD-1/L1 class to win FDA approval to treat NSCLC after surgery. That 2021 nod was limited to PD-L1-positive, stage 2 to 3a NSCLC.
Merck & Co.’s Keytruda in January followed with a broader approval covering stage 1b to 3a disease regardless of the tumor’s PD-L1 expression status.
In metastatic NSCLC, doctors typically use targeted therapies—rather than immunotherapy—when the tumor bears an addressable biomarker such as ALK or EGFR abnormalities.
In December 2020, AstraZeneca’s Tagrisso earned the FDA’s blessing to treat early-stage, EGFR-mutated NSCLC after surgery. Updated results from the phase 3 ADAURA trial, presented in June, showed that adjuvant Tagrisso lowered the risk of death by 51% compared with placebo.
Compared with EGFR-mutant cases, ALK-positive patients represent a much smaller NSCLC subgroup, accounting for about 5% of the total. Meanwhile, several ALK inhibitors are on the market. These include Pfizer’s first-generation med Xalkori and third-generation Lorbrena.
Alecensa, Novartis’ Zykadia and Takeda’s Alunbrig are the second-generation options. Last year, Xalkori’s sales dropped 6% to $465 million, as Lorbrena’s sales climbed 29% to $343 million. For Roche, Alecensa generated CHF 1.5 billion ($1.7 billion) last year, up 15% at constant currencies from 2021. At Takeda, Alunbrig generated JPY 20.6 billion ($142 million) for the 12 months ended in March, a 51% jump year over year.
A search in clinicaltrials.gov showed that Roche is the only company among the group that’s testing its ALK inhibitor in the adjuvant setting.

https://www.fiercepharma.com/pharma/following-tecentriqs-footsteps-alecensa-gives-roche-another-win-early-stage-lung-cancer