- Roche on Friday said one of its medicines succeeded in a Phase 3 trial of people whose lung tumors were driven by a well-known cancer gene, positioning its therapy to become the first available in that specific setting.
- Upon an interim analysis, study investigators found the drug, Alecensa, held disease in check longer than standard chemotherapy in patients whose non-small cell lung cancer was positive for a gene called ALK. Trial participants had Stage IB to IIIA tumors that were surgically removed.
- Roche said survival results were “immature” at the time of the evaluation, and didn’t provide further details. It plans to submit the results to regulators in the U.S., Europe and elsewhere, and present them at a future medical meeting.
Treatment for non-small cell lung cancer, one of the most common tumor types, has changed substantially in recent years.
Drugs that spur on the immune system have become standard for many patients with metastatic disease, extending survival in ways other drugs previously hadn’t. They’ve proved beneficial earlier in disease, too, becoming available for patients in the so-called neoadjuvant or adjuvant settings, before or after a tumor is removed surgically.
Medicines targeting genetic drivers of certain lung tumors, like EGFR and ALK, have emerged alongside. Treatments aimed at another lung cancer target, TROP2, are in late-stage testing for advanced disease. At a major medical meeting this year, AstraZeneca showed its drug Tagrisso cut the relative risk of death in half as an adjuvant therapy for patients whose tumors have EGFR mutations. Drugs are also available for patients with so-called RET fusions or whose tumors are ROS1-positive.
Roche is now claiming an advance for the estimated 5% of patients with ALK mutations, another well-known tumor type. Those with metastatic disease have a number of targeted medicines available, from Alecensa to Pfizer’s Xalkori and Takeda’s Alunbrig. But none are approved for earlier use, before a tumor has spread elsewhere and is easier to eliminate. Cancer recurs in about half of patients whose lung tumors are surgically removed, according to Roche.
The study Roche conducted involved 257 patients who were randomly assigned to receive Alecensa or chemotherapy after surgery. Roche said its drug met one of the study’s two main goals, delaying cancer recurrence in a result the company referred to, without specifics, as “unprecedented.”
“These strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” said Roche’s Chief Medical Officer and head of product development, Levi Garraway, in a statement.
Garraway added that the results would be shared with regulators “as quickly as possible.”
No “unexpected” safety findings were observed, the company said.