Approval based on the Phase III IMpower130 study showing the Tecentriq plus chemotherapy combination demonstrated a significant overall survival and progression-free survival benefit
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[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Basel, 4 December 2019 ? Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) approved Tecentriq? (atezolizumab) in combination with chemotherapy (Abraxane? [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.
?We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer,? said Levi Garraway, M.D., Ph.D., Roche?s Chief Medical Officer and Head of Global Product Development. ?Today?s approval offers another opportunity to help prolong the lives of people with this type of the disease.?
This approval is based on results from the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months; hazard ratio [HR]=0.80; 95% CI: 0.64?0.99; p=0.0384) in the intention-to-treat wild-type (ITT-WT) population.1?The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months; HR=0.75; 95% CI: 0.63?0.91; p=0.0024) in the ITT-WT population.1
Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared with 60.3% of people receiving chemotherapy alone.
In lung cancer, Tecentriq is also approved in the US in combination with Avastin? (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for NSCLC harbouring these aberrations prior to receiving Tecentriq. Tecentriq is also approved in the US in combination with carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Roche has an extensive development programme for Tecentriq, including nine Phase III studies underway across different types of lung cancer, and multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMpower130 study
IMpower130 is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with nab-paclitaxel and carboplatin versus chemotherapy (nab-paclitaxel and carboplatin) alone for chemotherapy-na?ve patients with stage IV non-squamous NSCLC. The study enrolled 724 people, of whom 681 were in the ITT-WT population and were randomised (2:1) to receive:
- Tecentriq plus nab-paclitaxel and carboplatin (Arm A), or
- Nab-paclitaxel and carboplatin (Arm B, control arm)
- PFS, as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations (the ITT-WT population)
- OS in the ITT-WT population
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