TECENTRIQ - ES-SCLC

Lung cancer - New indication

Opinions on drugs - Posted on May 20 2020

Reason for request

New indication

New indication.

Favourable opinion for reimbursement in the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with carboplatin and etoposide.

What therapeutic improvement?

Therapeutic improvement compared to carboplatin + etoposide chemotherapy.

Role in the care pathway?

The treatment of extensive-stage small cell lung cancer (ES-SCLC) is based on a combination of chemotherapies, with several protocols having demonstrated similar efficacy.

The first-line treatment is the cisplatin + etoposide protocol for 4 to 6 cycles. For elderly, frail patients (ECOG ≥ 2) or in whom the use of cisplatin is contraindicated, the use of carboplatin is recommended.

Other protocols may also be used, particularly in the event of a contraindication to etoposide (cisplatin or carboplatin + irinotecan, gemcitabine + carboplatin, cisplatin + topotecan etc.).

Prophylactic cranial irradiation is recommended for patients in good general condition (ECOG 0 to 2) who have responded to a first treatment line and in whom brain imaging is negative.

Role of the medicinal product in the care pathway

TECENTRIQ (atezolizumab), used in combination with carboplatin + etoposide chemotherapy, then alone as a maintenance therapy, is a first-line treatment in adult patients with extensive-stage small cell lung cancer (ES-SCLC).

The Committee nevertheless highlights that:

a subpopulation of “good responder” patients appears to benefit from long-term treatment, without it being possible to identify these patients,
no data are available in patients with an ECOG performance score > 1,
and that data are limited in patients with brain metastases.

Clinical Benefit

Substantial

The clinical benefit of TECENTRIQ is substantial in the MA indication.

Clinical Added Value

minor

Considering:

demonstration of the superiority of atezolizumab combined with carboplatin + etoposide chemotherapy compared to chemotherapy alone, in a randomised, double-blind study, in terms of progression-free survival and overall survival (primary endpoints),
the effect size, deemed to be modest but clinically relevant in view of the disease (increases of 0.9 months in PFS; HR = 0.77; CI_95%[0.62; 0.96] and 2 months in OS; HR = 0.70; CI_95%[0.54; 0.91]),

and despite:

the exploratory nature of the quality of life data,
the safety profile of the atezolizumab + carboplatin/etoposide combination, marked by a comparable frequency of grade ≥ 3 AEs and SAEs but a higher frequency of immunological AEs (32.3% vs 18.4%) and treatment discontinuations due to an AE (11.1% vs 3.1%),
uncertainty concerning the effect of atezolizumab given the difficulty in differentiating between the proportion attributable to the induction therapy in combination with chemotherapy and that attributable to maintenance therapy with atezolizumab alone,
and the impossibility of identifying “good responder” patients who appear to benefit from long-term treatment,

the Committee considers that TECENTRIQ (atezolizumab), in combination with carboplatin and etoposide, provides a minor clinical added value (CAV IV) compared to chemotherapy alone, in the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Documents

Economic analysis

TECENTRIQ CBPC 11032020 AVIS EFFICIENCE

English version

TECENTRIQ_ES-SCLC_13052020_SUMMARY_CT18159

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