The European Commission has approved alectinib as monotherapy as adjuvant treatment after tumor resection in adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence. The marketing authorization application – specifies a note released today by Roche – is supported by data from the phase 3 Alina study, in which alectinib demonstrated a significant reduction in the risk of disease recurrence or death equal to 76% in patients with resected Alk-positive Nsclc.
“For the first time in Europe, people with Alk-positive NSCLC undergoing surgical resection have the possibility of being treated with an Alk inhibitor capable of significantly reducing the risk of disease recurrence or death – says Levi Garraway, MD , PhD, Chief Medical Officer and Head of Global Product Development Roche – This approval represents an important breakthrough for people at high risk of their cancer returning after surgery. With this new indication, the breakthrough benefits of alectinib can be extended to even more patients with Alk-positive lung cancer.”
Lung cancer is one of the leading causes of cancer death worldwide. More than 4,900 deaths are estimated per day on a global scale. Lung cancer can be classified into two types: non-small cell lung cancer (NSCLC) and small cell lung cancer. Nsclc accounts for approximately 85% of all cases. Currently, about half of all people with early-stage lung cancer (45-76%, depending on the stage of the disease) experience tumor recurrence after surgery, despite adjuvant chemotherapy. Treating lung cancer early, before it spreads, could help prevent the disease from coming back and give patients the best chance of a cure. “In the case of Nsclc Alk positive lung cancer in the initial stage – clarifies Filippo de Marinis, director of the Thoracic Oncology division of the European Institute of Oncology (IEO) in Milan and President of AIOT (Italian Association of Thoracic Oncology) – surgery is not always it is fully curative, as a high risk of recurrence persists, which can give patients strong worries about their future. The magnitude of the disease-free survival benefit observed in the Alina study is unprecedented and remains unchanged across all stages of the disease. Carrying out the test for the Alk biomarker promptly – he adds – becomes more of a priority than ever, to identify all patients who could benefit from this new and important therapeutic option”.
In the Alina study – published in the New England Journal of Medicine in April 2024 – alectinib reduced the risk of disease recurrence or death by 76% (hazard ratio = 0.24, 95% confidence interval: 0.13-0. 43, p < 0.0001) compared to platinum-based chemotherapy in stage Ib Nsclc Alk positive subjects [≥ 4 cm] a IIIA[accordingtotheUnionforInternationalCancerControl/AmericanJointCommitteeonCancer-Uicc/AjccstagingsystemVIIedition)completelyresectedAnimprovementinCNSdisease-freesurvivalwasobservedinanexploratoryanalysis(Hr=022;95%CI:008-058)ThisaspectisparticularlyimportantforsubjectswithAlk-positiveNSCLCwhoareatgreaterriskofdevelopingbrainmetastasesthanthosewithothertypesofNSCLCThesafetyandtolerabilityofalectinibintheAlinastudyweregenerallyconsistentwiththoseofpreviousstudiesinthemetastaticsettingandtherewerenounexpectedsafetyfindings[secondoilsistemadistadiazionedellaUnionforInternationalCancerControl/AmericanJointCommitteeonCancer-Uicc/AjccVIIedizione)completamenteresecatoInun’analisiesplorativaèstatoosservatounmiglioramentodellasopravvivenzaliberadamalattiaalivellodelsistemanervosocentrale(Hr=022;Ical95%:008-058)QuestoaspettoèparticolarmenteimportanteperisoggetticonNsclcAlk-positivochesonomaggiormenteespostialrischiodisvilupparemetastasicerebralirispettoaquelliconaltritipidiNsclcLasicurezzaelatollerabilitàdialectinibnellostudioAlinasonorisultategeneralmentecoerenticonquelledistudiprecedentinelsettingmetastaticoenonsonoemersielementiimprevistirelativiallasicurezza
Alectinib is the optimal therapeutic option for patients with advanced Alk-positive NSCLC and has significantly improved the outcomes, therefore the clinical results, of people affected by this disease. Approved in more than 100 countries as a first- and second-line drug, it has been used to treat over 94,000 patients with advanced disease. Following its approval in the adjuvant treatment setting, alectinib could play, for the first time, a fundamental role in resectable Alk-positive disease, where there is a significant unmet clinical need. Today’s approval in Europe – we read in the note – follows that of the US Food and Drug Administration (FDA) in April 2024, which authorized alectinib as an adjuvant treatment after tumor resection in patients with Alk-positive Nsclc (tumors ≥ 4 cm or with positive lymph nodes) identified by an FDA-approved test. Submissions to other health authorities around the world are currently underway, with the aim of making this new therapeutic option available to as many patients as possible.
To support physicians’ decision-making, international guidelines, including those for clinical practice in oncology of the National Comprehensive Cancer Network (NCCN Guidelines), recommend systematically testing biopsy or tissue specimens obtained from surgical resection for the biomarkers Alk, Egfr and Pd-L1 in patients with stage IB to IIIA Nsclc and with some forms of stage IIIB Nsclc (according to the Uicc/Ajcc staging system, VIII edition), as well as in the advanced setting.
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