Monday, Oct 22, 2018
The Phase III IMpower130 study investigating the Tecentriq plus chemotherapy combination demonstrated a significant overall survival (OS) and progression-free survival (PFS) benefit
Data will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress on October 22, 2018
South San Francisco, CA -- October 22, 2018 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III IMpower130 study of Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of people with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC). The analysis showed that Tecentriq plus chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS] = 18.6 versus 13.9 months; hazard ratio [HR] = 0.79; 95 percent CI: 0.64–0.98; p=0.033) in the intention-to-treat wild-type (ITT-WT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared to chemotherapy alone (median PFS=7.0 versus 5.5 months; HR=0.64; 95 percent CI: 0.54–0.77; p<0.0001) in the ITT-WT population. Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.
“Initial treatment with this Tecentriq-based combination provided a significant survival benefit for people with non-squamous non-small cell lung cancer, the most common form of lung cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Lung cancer is a complex disease and this combination could offer a new potential treatment option. We will work with global health authorities to bring this regimen to people living with this disease as soon as possible.”
The data will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress on October 22, 2018 from 9:15 – 9:30 a.m. CEST (Abstract LBA53; Hall A1 – Room 17).
About the IMpower130 study
IMpower130 is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 723 people who were randomized (2:1) to receive:
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurs first. People received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.
During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurs first. People received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until disease progression.
The co-primary endpoints were:
IMpower130 met its co-primary endpoints of OS and PFS.
A summary of the results are included below:
Arm A (Tecentriq plus chemotherapy) vs Arm B (chemotherapy) in ITT-WT | |||
Arm A n=451 | Arm B n=228 | ||
| Median OS, months (95% CI) | 18.6 (16.0–21.2) | 13.9 (12.0–18.7) | |
| HR (95% CI); P value | 0.79 (0.64, 0.98); p=0.033 | ||
| 1-year OS, % (95% CI) | 63.1 (58.59–67.66) | 55.5 (48.89–62.17) | |
| Confirmed ORR, % (95% CI) | 49.2 (44.49–53.96) | 31.9 (25.84–38.36) | |
| Median DoR, months (95% CI) | 8.4 (6.9–11.8) | 6.1 (5.5–7.9) | |
| Median PFS (95% CI), months | 7.0 (6.2–7.3) | 5.5 (4.4–5.9) | |
| HR (95% CI); P value | 0.64 (0.54, 0.77); p<0.0001 | ||
| 1-year PFS rate, % (95% CI) | 29.1 (24.83–33.44) | 14.1 (9.37–18.76) | |
| 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 73.2 percent of people receiving Tecentriq plus chemotherapy compared to 60.3 percent of people receiving chemotherapy alone. The most common Grade 3-4 AEs in people receiving Tecentriq plus chemotherapy were: an abnormal low count of a certain type of white blood cell (neutropenia, 32.1 percent), a decrease in red blood cells (anemia, 29.2 percent) and a decreased neutrophil count (12.1 percent).
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.
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.
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
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.
About Genentech
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.
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