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July 23, 2018

Roche reports positive interim data from Mpower132 trial

Roche has reported a positive outcome from the IMpower132 study after an interim analysis showed that the trial met one of its co-primary endpoints of progression-free survival (PFS).

Roche has reported a positive outcome from the IMpower132 study after an interim analysis showed that the trial met one of its co-primary endpoints of progression-free survival (PFS).

IMpower132 is a Phase III, open-label, randomised trial designed to analyse the efficacy and safety of Tecentriq (atezolizumab) in combination with chemotherapy, including cisplatin or carboplatin and pemetrexed versus chemotherapy alone for the treatment of advanced non-squamous non-small cell lung cancer (NSCLC).

The trial enrolled 578 chemotherapy-naïve patients with advanced NSCLC.

During the trial, the patients were randomised in 1:1 ratio to receive Tecentriq in combination with cisplatin or carboplatin and pemetrexed in the arm A.

In arm B or the control arm, patients received cisplatin or carboplatin and pemetrexed.

In the treatment-induction phase of the trial, patients received Tecentriq, pemetrexed and either cisplatin or carboplatin on day one of every three weeks for a dosing period of four or six cycles.

“The IMpower132 study showed Tecentriq plus chemotherapy prolonged the time people with this type of advanced lung cancer lived without their disease worsening.”

The patients who experienced clinical benefit during the induction phase started maintenance therapy until disease progression.

The trial’s co-primary endpoints were PFS as determined by the response evaluation criteria in solid tumours (RECIST) v1.1 and overall survival (OS).

Roche chief medical officer and Global Product Development head Sandra Horning said: “The IMpower132 study showed Tecentriq plus chemotherapy prolonged the time people with this type of advanced lung cancer lived without their disease worsening.

“We will discuss these results with health authorities.”

Roche further noted that despite observing a numerical improvement for the co-primary endpoint of OS, the trial has not achieved any statistical significance until the time of the interim analysis.

The company plans to continue the Mpower132 trial as scheduled and expects to obtain final OS results next year.

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