Atezolizumab Extends Disease-Free Survival in Patients with PD-L1 Positive Early NSCLC

Pharmaceutical maker Roche says its monoclonal antibody (atezolizumab) Tencentriq has been shown to be successful at reducing the risk of recurrence or death in a subset of patients with non-small-cell lung cancer (NSCLC) whose tumors express at least 1% programmed death-ligand 1 (PD-L1).

The findings come from new interim results from the phase III IMpower010 study. Roche announced the results ahead of the American Society of Clinical Oncology’s 2021 annual meeting, which takes place next month.

About half of people with stage I-III lung cancer will experience recurrence following surgery. The IMpower010 study is a global, open-label, randomized trial comparing atezolizumab with best supportive care in patients with Stage IB-IIIA NSCLC who have undergone surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy.

The 1,005 people randomized into the trial were split in half, with one arm receiving up to 16 cycles of atezolizumab or best supportive care. The primary endpoint was disease-free survival in PD-L1-positive patients in stages II-IIIA, all randomized patients in stages II-IIIA, and stage IB-IIIA patients in an intent-to-treat group.

The new interim data specifically deal with patients in the PD-L1-positive group. Among those patients, Roche said, atezolizumab following chemotherapy and surgery improved DFS by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88). The median DFS was 35.3 months for the best-supportive-care arm, but median DFS had not yet been reached in the atezolizumab arm.

“These landmark phase III data demonstrate for the first time that cancer immunotherapy can bring a clinically meaningful improvement to certain people with early lung cancer in the adjuvant setting,” said Roche’s chief medical officer, Levi Garraway, MD, PhD, in a press release. Garraway added that the data could lead to a new approach to the treatment of early-stage lung cancer.

The company also released results from the larger study population. They showed that, in all randomized stage II-IIIA participants, the drug improved DFS by 21% (HR=0.79, 95% CI: 0.64-0.94). Overall, that translated to a median DFS of 42.3 months for patients in the atezolizumab group versus 35.3 months in the best supportive care group.

Follow-up will continue in the overall intent-to-treat population, the company said.

Julia R. Gralow, MD, chief medical officer at ASCO, said the data mark the first time an immunotherapy has been shown to be effective in early-stage lung cancer.

“The IMpower010 trial demonstrates that, for certain patients, atezolizumab can delay progression to advanced disease, and perhaps even the need for more aggressive therapy,” she said, in a press release. “This could be an important advance in our understanding of immunotherapy and a step forward for many patients with lung cancer.”

The therapy led to adverse events in 92.7% of patients, versus 70.7% in the best supportive care group. About 1 in 5 patients in the therapy group (21.8%) had grade 3-4 adverse events, versus 11.5% in the control group. Adverse events led to treatment withdrawal for 18.2% of patients in the atezolizumab group, but no such withdrawals were noted in the best supportive care group.

Atezolizumab already has 4 indications in NSCLC in addition to indications in extensive-stage small cell lung cancer, among other indications. In addition to the IMpower010 study, the drug is also being studied across a variety of cancer types and settings.

Jared Kaltwasser is a healthcare writer in Iowa.