Tecentriq Combination Shows Positive Interim Results for Untreated Advanced Lung Cancer in Phase 3 Trial

Tecentriq Combination Shows Positive Interim Results for Untreated Advanced Lung Cancer in Phase 3 Trial

Tecentriq (atezolizumab) in combination with chemotherapy reduces the risk of disease progression or death in people with previously untreated advanced squamous non-small cell lung cancer (NSCLC), according to interim data from Roche‘s Phase 3 clinical trial.

Non-small cell lung cancer is an aggressive and difficult-to-treat cancer. It is the most commonly diagnosed type of lung cancer, and the squamous form accounts for about 25 to 30 percent of all NSCLC cases.

“Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades,” Sandra Horning, MD, Roche’s chief medical officer and head of global product development, said in a press release.

Tecentriq, developed by Genentech — a member of the Roche Group — is a monoclonal antibody designed to identify and block PD-L1, a molecule found in high levels on the surface of cancer cells. PD-L1 interacts with its receptor PD-1 located in immune cells, suppressing their immune activity. Blocking PD-L1 helps boost the immune response against cancer cells.

Tecentriq immunotherapy has been approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC in patients whose disease progressed during or after platinum-based chemotherapy. Roche believes it can also be used as a first-line treatment for advanced NSCLC, in combination with chemotherapy.

To explore that hypothesis, the company developed a Phase 3 clinical trial investigating the effectiveness and safety of Tecentriq added on to chemotherapy, compared with chemotherapy alone, in people with previously untreated advanced squamous non-small cell lung cancer.

The ongoing open-label, multicenter, randomized study, called IMpower131 (NCT02367794), enrolled 1,021 adults with stage IV squamous NSCLC. Participants were randomized to receive Tecentriq plus Paraplatin (carboplatin) and Abraxane (albumin-bound paclitaxel; nab-paclitaxel); Tecentriq plus Paraplatin and Taxol (paclitaxel); or Paraplatin and Abraxane (chemotherapy alone).

After induction treatment, patients receiving chemotherapy alone got best supportive care, while the rest of the participants received maintenance therapy with Tecentriq every three weeks until their disease worsened or for as long as clinical benefit was observed.

The study’s primary goals were to observe an increase in progression-free survival (PFS) — the length of time in which there is no disease progression — and overall survival in patients receiving the combination of Terentriq plus chemotherapy, compared with chemotherapy alone.

Interim results showed that the PFS endpoint was met, as Tecentriq plus Paraplatin and Abraxane reduced the risk of the disease worsening or death, compared with chemotherapy alone. However, so far, those patients have not shown a significant increase in overall survival.

By design, the clinical trial requires that overall survival reach statistical significance between these two groups of patients before PFS and overall survival can be analyzed between patients receiving Tecentriq along with Paraplatin and Taxol, and chemotherapy alone.

The safety profile of the combination therapy was similar to the individual treatments, with no new concerns reported.

The study will go on as planned, and further data and analysis are expected to clarify the clinical benefits of the combination therapy in untreated advanced squamous non-small cell lung cancer.

According to Roche, the interim results will be presented at a future cancer congress.