Genentech (RHHBY) Announces Significant Data from TECENTRIQ Phase 3 Data in Specific Lung Cancer
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Genentech, a member of the Roche Group (OTC: RHHBY), announced data from the positive, pivotal Phase III OAK study of TECENTRIQ (atezolizumab) at the European Society of Medical Oncology (ESMO) 2016 Annual Meeting in Copenhagen, Denmark. The study showed TECENTRIQ helped people live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 - 0.87). The OAK study evaluated people with non-small cell lung cancer (NSCLC) whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line). The study enrolled people regardless of their programmed death-ligand 1 (PD-L1) status and included both squamous and non-squamous disease types. Adverse events (AEs) were consistent with those observed in previous TECENTRIQ studies.
“TECENTRIQ is the first and only anti-PD-L1 cancer immunotherapy to help people with metastatic NSCLC live significantly longer than chemotherapy regardless of their PD-L1 expression level or their disease histology,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Even people whose disease had low or no observed PD-L1 expression still showed a significant benefit from the medicine.”
The FDA granted Breakthrough Therapy Designation (BTD) for TECENTRIQ for the treatment of people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor). Genentech’s Biologics License Application (BLA) for NSCLC was granted Priority Review with an action date of Oct. 19, 2016.
Genentech has eight Phase III lung studies underway evaluating TECENTRIQ alone or in combination with other treatments in people with early and advanced stages of lung cancer.
Full results from the OAK study will be presented in the Presidential Symposium in a presentation by Fabrice Barlesi, Assistance Publique Hôpitaux de Marseille, Marseille, France (abstract #LBA44) on Sunday, Oct. 9, 4:25 p.m. Central European Time (CET). Primary analysis from OAK, a randomized Phase III study comparing atezolizumab with docetaxel in advanced NSCLC
About the OAK study
OAK is a global, multicenter, open-label, randomized, controlled Phase III study that evaluated the efficacy and safety of TECENTRIQ compared with docetaxel in 1,225 people with locally advanced or metastatic NSCLC whose disease had progressed following previous treatment with platinum-containing chemotherapy, with the primary analysis consisting of the first 850 randomized patients. Approximately one-quarter of patients had squamous disease (26 percent). Patients were randomized (1:1) to receive either TECENTRIQ administered intravenously at 1200 mg every 3 weeks or docetaxel administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or disease progression. The co-primary endpoints were OS in all randomized patients (intention-to-treat [ITT] population) and in a PD-L1-selected subgroup in the primary analysis population. A summary of the OAK results is included below.
|Overall survival results|
(first 850 randomizedpatients)
TC1/2/3 or IC1/2/3
(PD-L1 expression on ≥1% TCor IC)
TC0 or IC0
(PD-L1 expression on <1% TC andIC)
T = TECENTRIQ
D = Docetaxel
95% CI: 0.62 - 0.87
P = .0003
95% CI: 0.58 - 0.93
P = .0102
95% CI: 0.59 - 0.96
P = .0205
|Overall survival by histology|
T = TECENTRIQ
D = Docetaxel
95% CI: 0.60 – 0.89
95% CI: 0.54 – 0.98
|Safety-evaluable population (N=1187)|
•Adverse events were consistent with those observed in previous studies of TECENTRIQ.
•Fewer people receiving TECENTRIQ experienced treatment-related Grade 3-4 AEs compared to docetaxel (15% vs. 43%).
•AEs occurring more frequently (5% or more) for TECENTRIQ were musculoskeletal pain (11% for TECENTRIQ vs. 4% for docetaxel) and pruritus (8% for TECENTRIQ vs. 3% for docetaxel).
•There were no deaths related to TECENTRIQ and 1 related to docetaxel.
The demographics and baseline characteristics were balanced between two arms. Patients had a median age of 64 years and 61% were male. 25% had 2 prior lines of therapies, and 18% never smoked. Baseline ECOG performance status was 0 (37%) or 1 (63%). About 17% of people in the docetaxel arm received immunotherapy as the subsequent therapy.
|*Unstratified for the TC0 and IC0 subgroup, stratified for others.|
|**Stratified log-rank p value.|
CI: confidence interval; ITT: intention-to-treat; HR: hazard ratio; TC: tumor cells; IC: tumor-infiltrating immune cells; PD-L1: programmed death-ligand 1; OS: overall survival
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