Roche yesterday presented new data from the phase-III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%. Data from the IMpower010 trial were published simultaneously in The Lancet, said a company statement.
In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34 per cent (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with stage II-IIIA NSCLC whose tumours express PD-L1≥1%, compared with the best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.
“Today, more than half of all people with early-stage NSCLC experience recurrence following surgery,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche. “IMpower010 shows how, for the first time, a cancer immunotherapy may help many of these patients live longer without their disease returning. The data presented at ESMO and WCLC further contribute to our understanding of Tecentriq in this treatment setting.”
The statement also said at the 2021 ESMO Virtual Congress, new real-world data show that almost three-quarters of patients with early-stage NSCLC in the US did not receive adjuvant treatment, despite guideline recommendations. Data presented from IMpower010 show that adjuvant Tecentriq offers a DFS benefit in the stage II-IIIA patient population, irrespective of the stage of disease and across the main prior therapies. Specifically, time to relapse appeared to be improved with Tecentriq, compared with BSC, among people with stage II-IIIA NSCLC whose tumours express PD-L1 TC ≥1%, for both locoregional and distant sites. There was no clear difference in patterns of relapse. An extended analysis of PD-L1 subgroups in the stage II-IIIA population shows there is a higher magnitude of benefit from adjuvant Tecentriq in people with PD-L1 expression ≥50%, compared with those with 1-49% PD-L1 expression. The exploratory nature of the analysis in patients with one to 49 per cent PD-L1 expression prevents any firm conclusions, and these data will be further analysed and shared at a future medical congress.
Additional IMpower010 data, recently presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (WCLC) Presidential Symposium, showed that treatment with Tecentriq improved DFS in the PD-L1≥1% stage II-IIIA NSCLC population, compared with BSC, regardless of most surgery types and adjuvant chemotherapy regimens.
Based on the IMpower010 data, the US Food and Drug Administration (FDA) recently granted Priority Review to Tecentriq as an adjuvant treatment for certain people with early NSCLC and is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The FDA is expected to make a decision on approval by 1st December, 2021.
Tecentriq has previously shown clinically meaningful benefits in various types of lung cancer, with five currently approved indications in markets around the world. It was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.
Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned phase-III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.