480 0 Kommentare European Commission approves Roche's Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer - Seite 2

About the IMpower150 study
IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. A total of 1,202 people were enrolled and were randomised (1:1:1) to receive:

Tecentriq plus carboplatin and paclitaxel (Arm A), or
Tecentriq and Avastin plus carboplatin and paclitaxel (Arm B), or

Avastin plus carboplatin and paclitaxel (Arm C, control arm)

The co-primary endpoints comparing Arms B and C were OS and progression-free survival (PFS), as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) and assessed in the ITT-WT subpopulation. Key secondary endpoints included investigator-assessed PFS, OS and safety in the ITT population.

A summary of the ITT data from the IMpower150 study that supported this approval is included below:^[1]

Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer, compared with Avastin and chemotherapy (median OS=19.8 versus 14.9 months; HR=0.76; 95% CI: 0.63-0.93; p=0.006).
In addition, Tecentriq in combination with Avastin and chemotherapy reduced the risk of disease worsening or death (PFS) by 41%, compared with Avastin and chemotherapy (HR=0.59; 95% CI: 0.50-0.69, p<0.0001).
Tecentriq in combination with Avastin and chemotherapy shrank tumours (overall response rate [ORR]) in 56.4% of people (95% CI: 51.4-61.4) compared with 40.2% of people (95% CI: 35.3-45.2) on Avastin and chemotherapy.
- 2.8% of people receiving Tecentriq in combination with Avastin and chemotherapy experienced a complete response (CR), and 53.7% of people experienced a partial response (PR).
The median duration of response (DoR) for people receiving Tecentriq in combination with Avastin and chemotherapy was 11.5 months (95% CI: 8.9-15.7) compared with 6.0 months (95% CI: 5.5-6.9) for people on Avastin and chemotherapy.
The most common adverse reactions (>=20%) in people receiving Tecentriq in combination with Avastin and chemotherapy were fatigue and lack of energy (asthenia; 50%), hair loss (alopecia; 48%), nausea (39%), diarrhoea (32%), constipation (30%), decreased appetite (29%), joint pain (arthralgia; 26%), hypertension (25%), and pain from nerve damage (peripheral neuropathy; 24%).