Phase 3 Trial of Adjuvant Atezolizumab in Resectable NSCLC Meets DFS End Point

Patients with stage IB to IIIA non–small cell lung cancer (NSCLC) who were treated with atezolizumab (Tecentriq) as adjuvant therapy following surgery had better rates of disease-free survival (DFS) when compared against those receiving best supportive care, according to data from the phase 3 IMpower010 trial (NCT02486718).

Roche, the company responsible for developing the agent, reported a statistically significant improvement in the DFS primary end point with the experimental regimen, with the magnitude of benefit most pronounced in those with PD-L1 positivity.

“With these landmark results, [atezolizumab] has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a press release. “We’re excited by the clinical benefit adjuvant [atezolizumab may bring to patients with lung cancer], particularly in the PD-L1–positive population. We will submit these data to regulatory authorities as soon as possible.”

The trial will continue to assess DFS in the intention-to-treat population (ITT), which had not yet crossed the threshold for significance at the current analysis. The primary outcome measure includes assessing DFS in patients with high PD-L1 expression, in all randomized patients with stage II to IIIA disease and in the ITT population.

Overall survival, a key secondary end point in the ITT population, will also need to be examined at a later time as these data are currently immature. Other secondary end points include percentage of patients who are disease free at 3 and 5 years, DFS in selected populations, and safety.

The investigators reported that the safety profile is consistent with the know toxicities associated with the agent, with no new apparent safety signals emerging. Full results of the trial are expected at an upcoming medical meeting.

Patients who are included in the trial population are those with an ECOG performance status of 1 or 0, histologically or cytologically diagnosis of stage II to IIIA disease, complete resection between 4 and 12 weeks prior to enrollment who are recovered from surgery, cisplatin eligibility, and adequate hematologic and end-organ function. Participants receive up to 4 21-day cycles of cisplatin-based chemotherapy and are randomized in a 1:1 fashion to intravenous atezolizumab 1200 mg every 3 weeks for 16 21-day cycles or best supportive care.

Currently, atezolizumab is approved for 5 indications in the treatment of lung cancer, 4 of which are for the NSCLC. Of note, atezolizumab was the first immunotherapy to receive approval for the treatment of patients with extensive-stage small cell lung cancer. Other applications of the PD-L1 inhibitor include urothelial cancer, triple-negative breast cancer, hepatocellular carcinoma, and melanoma. The agent is being explored across multiple indications—including genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers—both as monotherapy and in combination with other anticancer therapies.

The company plans a full readout of available data from IMpower010 for presentation at an upcoming medical meeting. Results will also be submitted to health authorities globally, including the FDA.

References

Pivotal Phase III study shows Roche’s Tecentriq helped people with early lung cancer live longer without their disease returning. News release. Roche. March 22, 2021. Accessed March 22, 2021. https://www.roche.com/media/releases/med-cor-2021-03-22.htm