Quote this publication Share Print

TAGRISSO (osimertinib) - Cancer bronchique non à petites cellules (CBNPC)

Opinions on drugs - Posted on May 30 2022

Reason for request

New indication

Key points

Favourable opinion for reimbursement only in the adjuvant treatment after complete tumour resection and after adjuvant chemotherapy if indicated in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

Unfavourable opinion for reimbursement in other adjuvant situations.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

The treatment of patients with resectable stage IB-IIIA disease is based on French Auvergne Rhône-Alpes (AURA) and international (ESMO, NCCN) guidelines. No targeted therapies are currently available in routine clinical practice, as adjuvant treatment, for patients with a EGFR mutation at these stages of the disease.

For resectable stages I and II:

  • Complete anatomical resection surgery, including complete lymphadenectomy, is recommended. Neoadjuvant chemotherapy may be proposed in some patients following the opinion of a multidisciplinary team. For stage II disease, adjuvant chemotherapy (cisplatin and vinorelbine) is recommended in all patients in good enough physical and physiological condition to receive it. Adjuvant chemotherapy is not recommended for postoperative stage I disease.

For resectable stage IIIA disease in medically operable patients, there are two treatment options:

  • resection surgery, preceded by 2 to 4 cycles of cisplatin-based chemotherapy, if the patient’s general condition allows such treatment and in the absence of contraindications,
  • resection surgery followed by 4 cycles of adjuvant platinum-based chemotherapy.

In the event of incomplete resection, postoperative chemoradiotherapy may be discussed.

Role of the medicinal product in the care pathway

TAGRISSO (osimertinib) is an adjuvant treatment after complete tumour resection followed by adjuvant chemotherapy if indicated in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. The Committee highlights the fact that, in adjuvant situations, patients should be treated until a recurrence of the disease or the development of unacceptable toxicity and that a treatment duration of more than 3 years has not been studied.

To date, the superiority of TAGRISSO (osimertinib) compared to placebo has only been demonstrated in terms of disease-free survival. The Committee is awaiting overall survival data from the ADAURA study (provisional date for availability of results: 2023).


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of TAGRISSO (osimertinib) is Substantial only as monotherapy in the adjuvant treatment after complete tumour resection and after adjuvant chemotherapy if indicated in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

 

Insufficient

The Committee deems that the clinical benefit of TAGRISSO (osimertinib) is Insufficient to justify public funding cover in all other adjuvant situations.

 


Clinical Added Value

minor

Considering:

  • demonstration of the superiority of osimertinib compared to placebo in a double-blind phase III study in terms of disease-free survival with a significant reduction:
    • in stage II-IIIA patients (primary endpoint), HR=0.17; CI99.06% [0.11; 0.26]; p < 0.0001) and
    • in stage IB-IIIA patients (total population, ranked secondary endpoint), HR=0.20; CI99.12% [0.14; 0.30]; p < 0.0001),

and despite:

  • the immaturity of the overall survival data, preventing a conclusion being reached with respect to a benefit of TAGRISSO (osimertinib) compared to placebo for this endpoint 
  • the additional toxicity compared to placebo with, in particular, more grade ≥ 3 adverse events (20.2% versus 13.4%) or adverse events having led to treatment discontinuation (11% versus 2.9%),
  • the absence of any demonstrative data on quality-of-life,

The Committee considers that TAGRISSO (osimertinib), as adjuvant treatment, provides a minor clinical added value (CAV IV) compared to the current care pathway for patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumour resection and adjuvant chemotherapy if indicated. 


Contact Us

Évaluation des médicaments