MADRID, 20 May. (EUROPA PRESS) –
Roche has announced the initial results of the phase III study ‘IMpower010’, which show for the first time that treatment with ‘Tecentriq’ (atezolizumab) after surgery and chemotherapy reduces the risk of disease relapse or death by 34 percent in patients with stage II-IIIA non-small cell lung cancer (NSCLC), whose tumors express PD-L1, compared with best supportive therapy. In this population, mean DFS was not reached for ‘Tecentriq’ compared to 35.3 months for best supportive treatment.
In a larger population that included all randomized participants in the stage II-IIIA study, ‘Tecentriq’ reduced the risk of disease recurrence or death by 21 percent after a mean follow-up of 32.2 months. In this population, ‘Tecentriq’ increased DFS by a median of seven months (42.3 months versus 35.3 months). The safety data for ‘Tecentriq’ were consistent with those already known and no new findings were detected. The full results of ‘IMpower010’ will be presented at the Lung Cancer Oral Session on Sunday June 6 at the 2021 ASCO Annual Meeting.
“These landmark data from this phase III study demonstrate for the first time that cancer immunotherapy can bring a clinically significant improvement to selected people with early stage lung cancer as adjuvant therapy. These results lay the foundation for a new approach to treatment of early stage lung cancer and bring us closer to our goal of offering an effective therapeutic option tailored to each person diagnosed with this disease “, explained Roche’s medical director and head of Global Product Development, Dr. Levi Garraway.
The goal of adjuvant treatment is to reduce the risk of relapse and offer the best chance of cure. However, approximately half of patients with stage I-III NSCLC develop a recurrence of the disease after treatment with curative intent. Platinum adjuvant chemotherapy is the current standard treatment for patients with completely resected early-stage NSCLC (stage IB-IIIA) who are at high risk of disease relapse or recurrence. This treatment provides a modest 4-5 percent improvement in five-year survival compared to observation.
Follow-up will continue with the assessment of DFS in the global intention-to-treat (ITT) population, including stage IB patients, who at the time of analysis did not exceed the necessary statistical threshold, and also with (assessment of) the immature overall survival (OS) data at the time of interim analysis.
‘Tecentriq’ has previously shown a clinically significant benefit in various types of lung cancer, and has five indications currently approved in countries around the world. It was the first cancer immunotherapy approved for the first-line treatment of adults with advanced stage small cell lung cancer (SCLC), in combination with carboplatin and etoposide (chemotherapy). It is also approved for four indications against NSCLC as a single agent or in combination with targeted therapies and / or chemotherapy. ‘Tecentriq’ is available in three dosing options, offering the flexibility to choose dosing every two, three, or four weeks.
Roche has an extensive ‘Tecentriq’ clinical development program, which includes multiple Phase III studies currently underway and in different settings in lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancer. This includes studies evaluating ‘Tecentriq’ both in monotherapy and in combination with other drugs, as well as studies in metastatic, adjuvant and neoadjuvant stages in various types of tumors.
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