Roche Alecensa gets USFDA nod for ALK-positive early-stage lung cancer

“With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At Roche, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission.”

“The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy,” said Ken Culver, Director of Research and Clinical Affairs at ALK Positive, Inc. "These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC. Now, with this significant advance, it is more important than ever that all people diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them.”

The approval is based on positive results from the Phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.001) compared with platinum-based chemotherapy in people with completely resected IB (tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. In an exploratory analysis, an improvement of central nervous system (CNS) disease-free survival was observed (HR=0.22; 95% CI: 0.08-0.58). The safety and tolerability of Alecensa in this trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed. These data were presented as a late-breaking oral at the European Society of Medical Oncology Congress 2023 Presidential Symposium in October 2023 and were also recently published in the New England Journal of Medicine in April 2024.

Alecensa is a kinase inhibitor currently approved as first- and second-line treatment for ALK-positive metastatic NSCLC. It has demonstrated significant efficacy in patients, including those with CNS metastases, and now with this approval, these benefits could extend to people with early-stage disease. Routine testing of resected surgical tissue or biopsy for ALK, EGFR and PD-L1 biomarkers in patients with stage IB to IIIA and select IIIB (UICC/AJCC 8th edition) NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines), to support clinicians’ decision-making. About 5% of people with NSCLC are ALK-positive, equating to approximately 90,000 people worldwide diagnosed each year.

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. For this review, FDA collaborated with the Australian Therapeutics Goods Administration (TGA), Health Canada (HC), Israel’s Ministry of Health (IMoH) Pharmaceutical Administration, Switzerland’s Swissmedic, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (UK MHRA). Brazil's National Health Surveillance Agency (ANVISA) and Singapore’s Health Sciences Authority (HSA) will also be participating as Type C Project Orbis Partners.

Additionally, the FDA reviewed and approved the supplemental application under its Real-Time Oncology Review pilot programme. Data from the Phase III ALINA study will also be used for filing submissions to additional global health authorities, including the European Medicines Agency.

Lung cancer is one of the leading causes of cancer death globally. Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day. Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small-cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases. Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

Read also: CDSCO Panel Approves Roche's Protocol Amendment Proposal For Anti-cancer Drug Atezolizumab, Lenvatinib, and Sorafenib Study