Genentech’s TECENTRIQ in Combination With Pemetrexed and Platinum-Based Chemotherapy Reduced the Risk of Disease Worsening or Death in the Initial Treatment of People With Advanced Lung Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ^® (atezolizumab) plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). While a numerical improvement for the co-primary endpoint of overall survival (OS) was observed, statistical significance was not met at this interim analysis, and the study will continue as planned with final OS results expected next year. Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming medical meeting.

“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,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

About the IMpower132 study

IMpower132 is a Phase III, open-label, randomized study evaluating the efficacy and safety of TECENTRIQ plus chemotherapy (cisplatin or carboplatin and pemetrexed) versus chemotherapy alone in chemotherapy-naïve patients with advanced non-squamous NSCLC. The study enrolled 578 people who were randomized equally (1:1) to receive:

• TECENTRIQ in combination with cisplatin or carboplatin and pemetrexed (Arm A), or
• Cisplatin or carboplatin and pemetrexed (Arm B, control arm)

During the treatment-induction phase, people received TECENTRIQ, pemetrexed and investigator’s choice of either cisplatin or carboplatin on Day 1 of every three weeks for a dosing period of four or six cycles. People who experienced clinical benefit during the induction phase began maintenance therapy until disease progression.

The co-primary endpoints were:

• PFS as determined by the investigator using RECIST v1.1
• OS

IMpower132 met its PFS co-primary endpoint as per the study protocol.

About lung cancer

According to the American Cancer Society, it is estimated that more than 234,000 Americans will be diagnosed with lung cancer in 2018, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.