Roche announces positive phase 3 results for Alecensa in early-stage lung cancer
19 Oct 2023
Phase 3License out/inClinical Result
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Source: PMLiVE
Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer.
The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC).
A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting.
Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “By reducing the risk of recurrence or death of ALK-positive early-stage NSCLC by an unprecedented 76%, Alecensa can potentially alter the course of this disease as we aim to provide the best chance for cure.
Garraway added that the company is working with health authorities, including the European Medicines Agency and the US Food and Drug Administration, to "bring Alecensa to patients in this setting as soon as possible”.
Lung cancer is one of the leading causes of cancer death globally and NSCLC represents up to 85% of all lung cancer cases.
Approximately half of all patients with early-stage lung cancer still experience disease recurrence following surgery, despite adjuvant chemotherapy, and new treatments are needed to prevent the disease from returning and provide the best chance for cure, according to Roche.
Alecensa is already approved in over 100 countries as a first-line treatment for ALK-positive, metastatic NSCLC.
“This potentially practice-changing data reinforces the potential of Alecensa as a new standard of care in the ALK-positive early lung cancer setting where treatment options are currently extremely limited,” said professor Benjamin Solomon, medical oncologist at the Peter MacCallum Cancer CentreCancer Centre in Australia.
“The magnitude of disease-free survival observed in this study could represent a paradigm shift in the way we manage early-stage ALK-positive lung cancer,” he added.
The readout comes just a day after it was announced that Roche had entered into a $2bn collaboration and licensing agreement with Monte Rosa Therapeutics aimed at discovering and developing molecular glue degraders against targets in cancer and neurological diseases.
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