Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer

– First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival in people with unresectable hepatocellular carcinoma compared with sorafenib –

– Results will be presented in the Presidential session at the European Society for Medical Oncology (ESMO) Asia Congress 2019

SOUTH SAN FRANCISCO, CA, USA I November 22, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), will today present positive results from the Phase III IMbrave150 study evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab). The data show statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Tecentriq in combination with Avastin reduced the risk of death (OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib. Safety for Tecentriq and Avastin was consistent with the known safety profiles of the individual medicines.

“For the first time in a decade, we are seeing a treatment that has improved overall survival for people with unresectable hepatocellular carcinoma compared with the current standard of care,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Tecentriq in combination with Avastin could transform the treatment of this aggressive disease, and we are working closely with global health authorities in the hope of bringing this treatment option to patients as soon as possible.”

It is estimated that more than 42,000 people will be diagnosed with liver cancer in the U.S. this year, and approximately 75% will have HCC. Liver cancer is the most rapidly increasing cancer diagnosis in both men and women, with incidence rates more than tripling since 1980.

These data will be presented in the Presidential session at the European Society for Medical Oncology (ESMO) Asia Congress 2019 on November 23 at 11:00 a.m. (Singapore Standard time) (Abstract LBA3).

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMbrave150 study

IMbrave150 is a global Phase III, multicenter, open-label study of 501 people with unresectable HCC who have not received prior systemic therapy. People were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints were OS and PFS by independent review facility (IRF) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints included overall response rate (ORR), time to progression (TTP) and duration of response (DoR), as measured by RECIST v1.1 (investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as patient-reported outcomes (including time to deterioration of patient-reported quality of life), safety and pharmacokinetics.

Key efficacy endpoint results for OS and PFS (co-primary endpoints) are below:

  Tecentriq + Avastin
(n=336)
Sorafenib
(n=165)

Median OS (months)

(95% CI)

NE

13.2

(10.4, NE)

OS, HR (95% CI) 0.58 (0.42, 0.79)
Log rank p-value 0.0006

Median PFS (months)

(95% CI) IRF RECIST v1.1

6.8

(5.7, 8.3)

4.3

(4.0, 5.6)

PFS, HR (95% CI) 0.59 (0.47, 0.76)
Log rank p-value <0.0001

NE, not estimable (Median OS for Tecentriq + Avastin not yet reached. For the control arm, the upper CI limit was not estimable); median follow-up 8.6 months; PFS measured as per IRF RECIST v1.1.

Grade 3-4 adverse events (AEs) occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. Grade 5 AEs occurred in 5% and 6% of people, respectively.

About hepatocellular carcinoma

According to the American Cancer Society, it is estimated that more than 42,000 Americans will be diagnosed with liver cancer in 2019. HCC accounts for approximately 75% of all liver cancer cases in the United States. HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B and C), and alcohol consumption, and typically presents at an advanced stage where there are limited treatment options.

About the Tecentriq and Avastin combination

There is a strong scientific rationale to support further investigation of Tecentriq plus Avastin in combination. Avastin, in addition to its anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumor infiltration and enabling priming and activation of T-cell responses against tumor antigens.

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.

About Avastin® (bevacizumab)

Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize).

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used when your bladder cancer:

  • has spread or cannot be removed by surgery, and if you have any one of the following conditions:
    • you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for “PD-L1”, or
    • you are not able to take chemotherapy that contains any platinum regardless of “PD-L1” status, or
    • you have tried chemotherapy that contains platinum, and it did not work or is no longer working

The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

  • Tecentriq may be used with bevacizumab and the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your lung cancer:
    • has spread or grown, and
    • is a type of lung cancer called “non-squamous NSCLC”, and
    • your tumor does not have an abnormal “EGFR” or “ALK” gene
  • Tecentriq may be used alone when your lung cancer:
    • has spread or grown, and
    • you have tried chemotherapy that contains platinum, and it did not work or is no longer working, and
    • 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.

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:

  • has spread or cannot be removed by surgery, and
  • your cancer tests positive for “PD-L1”

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on results of an ongoing study to confirm benefit.

A type of lung cancer called small cell lung cancer (SCLC).

  • Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:
    • is a type of lung cancer called “extensive-stage small cell lung cancer,” which means that it has spread or grown.

It is not known if Tecentriq is safe and effective in children.

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 currently studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visithttp://www.gene.com/cancer-immunotherapy.

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.

SOURCE: Genentech

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