FDA approves Roche’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer

Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the US Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapyBasel, 19 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.Tecentriq monotherapy, until disease progression (or loss of clinical benefit, as assessed by the investigator), unacceptable toxicity or death; orCisplatin or carboplatin (per investigator discretion) combined with either pemetrexed
(non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint was OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints included investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR). AttachmentRoche_mediarelease_Impower110_FDA approval_19052020