Tuesday, Sep 25, 2018
First Phase III study to show a cancer immunotherapy-based combination significantly improved overall survival (OS) and progression-free survival (PFS) in the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
Data will be presented at the 2018 World Conference on Lung Cancer (WCLC) Presidential Symposium, featured in the press program and simultaneously published in the New England Journal of Medicine on September 25, 2018
South San Francisco, CA -- September 25, 2018 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III IMpower133 study of TECENTRIQ® (atezolizumab) plus carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of people with previously-untreated extensive-stage small cell lung cancer (ES-SCLC). The analysis showed that TECENTRIQ and chemotherapy helped people live significantly longer compared with chemotherapy alone (overall survival [OS] = 12.3 versus 10.3 months; hazard ratio [HR] = 0.70, 95 percent CI: 0.54-0.91; p=0.0069) in the intention-to-treat (ITT) population. The TECENTRIQ-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77, 95 percent CI: 0.62-0.96; p=0.017). 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.
“The results with this TECENTRIQ combination in the initial treatment of extensive-stage small cell lung cancer represent the first clinically meaningful advance in the disease in over 20 years,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Our goal is to find treatment options for all types of lung cancer, and we are eager to work with global health authorities to bring this TECENTRIQ regimen to people living with this particularly difficult-to-treat form of lung cancer as soon as possible.”
The data will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC) Presidential Symposium on Tuesday, September 25, 2018 at 9:00 – 9:15 a.m. EDT (Abstract PL02.07 Oral). The data will be simultaneously published in the New England Journal of Medicine, and will be featured in the WCLC press conference at 9:45 – 10:30 a.m. EDT.
About the IMpower133 study
IMpower133 is a Phase III, multicenter, double-blinded, randomized placebo-controlled study evaluating the efficacy and safety of TECENTRIQ in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve people with ES-SCLC. The study enrolled 403 people who were randomized equally (1:1) to receive:
During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with TECENTRIQ or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.
The co-primary endpoints were:
IMpower133 met its OS and PFS co-primary endpoints as per the study protocol. A summary of the results are included below:
Arm A (TECENTRIQ plus chemotherapy) vs Arm B (Placebo plus chemotherapy) in ITT
|Median OS |
(95% CI), months
|HR (95% CI); P value|
0.70 (0.54, 0.91); p=0.0069
|1-year OS rate, %|
|Median DOR, months|
|HR (95% CI)|
0.70 (0.53, 0.92)
(95% CI), months
|HR (95% CI)|
0.77 (0.62, 0.96)
|1-year PFS rate, %|
|CI, confidence interval; DoR, duration of response; HR, hazard ratio; ORR, objective response rate; PFS, progression-free survival|
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. Grade 3-4 treatment-related adverse events (AEs) were reported in 56.6 percent of people receiving TECENTRIQ plus chemotherapy compared to 56.1 percent of people receiving chemotherapy alone.
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. Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most prevalent type, accounting for around 85 percent of all lung cancer cases, and SCLC accounting for approximately 15 percent of all cases. 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.
About TECENTRIQ® (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the re-activation of T cells. TECENTRIQ may also affect normal cells.
TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)
TECENTRIQ is a prescription medicine used to treat:
A type of bladder and urinary tract cancer called urothelial carcinoma.
The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
It is not known if TECENTRIQ is safe and effective in children.
Important Safety Information
What is the most important information about TECENTRIQ?
TECENTRIQ can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
TECENTRIQ can cause serious side effects, including:
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if patients have severe side effects.
Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of TECENTRIQ in people with urothelial carcinoma include:
The most common side effects of TECENTRIQ in people with non-small cell lung cancer include:
TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.
Please visit http://www.Tecentriq.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
About Genentech in Personalized Cancer Immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, 10 of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.
About Genentech in Lung Cancer
Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.