ALECENSA (alectinib) - Non-small cell lung cancer (NSCLC)

The Committee deems that the clinical benefit of ALECENSA (alectinib) is substantial as monotherapy in the adjuvant treatment after complete tumour resection of adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence.

Considering:

• demonstration of the superiority of ALECENSA (alectinib) compared to chemotherapy as an adjuvant treatment, in a randomised, open-label study on the risk of disease recurrence or death, a clinically relevant endpoint;
• with a substantial size effect, with a risk reduction of 76% (HR = 0.24; 95% CI [0.13; 0.45]), p<0.0001) in stage II-IIIA patients and in the stage IB-IIIA population (HR = 0.24; 95% CI [0.13; 0.43], p<0.0001);
• its acceptable safety profile, without any new safety signals in this indication;
• the inadequately met medical need in patients with ALK+ NSCLC at high risk of recurrence, after complete resection;

but in view of:

• an open-label study;
• a primary efficacy endpoint of disease-free survival as determined by the investigator (but 94% of the results were reviewed by an independent review committee);
• a lower effect reported when disease-free survival was assessed by the independent review committee than when it was assessed by the investigator, whereas the primary endpoint was assessment by the investigator;
• the lack of data relative to:
  • overall survival;
  • any recurrence after 2 years of treatment with alectinib;
  • the efficacy and safety of alectinib treatment in combination with chemotherapy;
  • quality of life, which are sufficiently robust;
  • resistance to alectinib;
  • concerning the optimal duration of adjuvant treatment with alectinib;
• a predominantly Asian study population (55.6%); no interaction test is available for this criterion, therefore a risk of heterogeneity of effect cannot be excluded;

an unknown heterogeneity of the effect depending on stage, with only 26 stage Ib patients having been included.

the Committee deems that ALECENSA (alectinib) provides a minor clinical added value (CAV IV) in the care pathway in the adjuvant treatment after complete tumour resection of adult patients with ALK+ non-small cell lung cancer (NSCLC) at high risk of recurrence.