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Wednesday, May 18, 2016

FDA Grants Genentech’s Cancer Immunotherapy TECENTRIQ™ (atezolizumab) Accelerated Approval for People with a Specific Type of Advanced Bladder Cancer

  • First and only anti-PDL1 cancer immunotherapy approved by the FDA
  • First FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years

South San Francisco, CA -- May 18, 2016 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to TECENTRIQ™ (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

“TECENTRIQ is a new medicine that can work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We thank the scientists, doctors, patients and their families who made it possible to bring TECENTRIQ to people with advanced urothelial carcinoma.”

"Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn’t received the same attention within the cancer community as other common cancers,” said Diane Zipursky Quale, president and co-founder, Bladder Cancer Advocacy Network. “TECENTRIQ is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options.”

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. The indication for TECENTRIQ is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Today’s approval of TECENTRIQ is based on the Phase II IMvigor 210 study.

Possible serious side effects with TECENTRIQ include, but are not limited to, lung problems (pneumonitis), liver problems (hepatitis), intestinal problems (colitis), hormone gland problems (especially the pituitary, thyroid, adrenal glands and pancreas), nervous system problems (neuropathy and meningoencephalitis), eye problems, severe infections and severe infusion reactions. Additional information on these and other side effects can be found below.

TECENTRIQ will be available to people in the United States within one to two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking TECENTRIQ through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at http://www.Genentech-Access.com.

Genentech is also evaluating TECENTRIQ in a confirmatory Phase III study (IMvigor 211), which compares TECENTRIQ to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.

 

About the IMvigor 210 study

IMvigor 210 is an open-label, multicenter, two-cohort Phase II study that evaluated the safety and efficacy of TECENTRIQ in people with locally advanced or mUC, regardless of PD-L1 expression. People in a cohort of the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen (n=310) received a 1200-mg intravenous dose of TECENTRIQ on day one of 21-day cycles until unacceptable toxicity or either radiographic or clinical progression. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR). A summary of the efficacy and safety data from the IMvigor 210 study that supports this accelerated approval is included below. The median follow-up time for this cohort was 14.4 months.

 

All Patients

PD-L1 Expression Subgroups

 

n=310

 

PD-L1 Expression of < 5%

in ICs1

(n=210)

 

PD-L1 Expression

of ≥ 5% in ICs1

(n=100)

Number of IRF-assessed Confirmed Responders

46

20

26

ORR (%)

(95% CI)

14.8%

(11.1, 19.3)

9.5%

(5.9, 14.3)

26.0%

(17.7, 35.7)

Complete Response (CR) (%)

5.5%

2.4%

12.0%

Partial Response (PR) (%)

9.4%

7.1%

14.0%

Median DOR, months (range)

Not Reached

(2.1+, 13.8+)

12.7 months

(2.1+, 12.7)

Not Reached

(4.2, 13.8+)

1 PD-L1 expression in tumor-infiltrating immune cells (ICs)

+ Denotes a censored value

In a subset of people in the IMvigor 210 study with disease progression following neoadjuvant or adjuvant platinum-containing therapy (n=59), TECENTRIQ shrank tumors (ORR) in 22.0 percent (95 percent CI: 12.3, 34.7) of people.

The most common Grade 3-4 adverse reactions (≥ 2 percent) were: urinary tract infection (9 percent), anemia (8 percent), fatigue (6 percent), dehydration, intestinal obstruction (partial or complete blockage of the bowel), urinary obstruction, hematuria (blood in the urine; 3 percent), dyspnea (difficulty breathing; 4 percent), acute kidney injury, abdominal pain (pain in stomach area; 4 percent), venous thromboembolism (blood clots in the vein), sepsis (blood infection) and pneumonia (lung infection). Three people (0.9 percent) experienced either sepsis, pneumonitis (lung problems) or intestinal obstruction, which led to death. TECENTRIQ was discontinued for adverse reactions in 3.2 percent (10) of the 310 patients.

About metastatic urothelial carcinoma

According to the American Cancer Society (ACS), it is estimated that more than 76,000 Americans will be diagnosed with bladder cancer in 2016. About 11 percent of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. Approximately 96 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three to four times more likely to get bladder cancer during their lifetime than women.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of 350 in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.4 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.

About atezolizumab

Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1. Atezolizumab 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, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

TECENTRIQ U.S. Indications (pronounced ‘tē-SEN-trik’)

TECENTRIQ™ is a prescription medicine used to treat:

· A type of bladder cancer called urothelial carcinoma. TECENTRIQ may be used when bladder cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma) and,

· You have tried chemotherapy that contains platinum, 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

Important Information About TECENTRIQ

TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Getting medical treatment right away may help keep these problems from becoming more serious. The healthcare provider may treat the patient with corticosteroid or hormone replacement medicines. The healthcare provider may delay or completely stop treatment with TECENTRIQ if severe side effects occur.

 

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:

  • Lung Problems (pneumonitis) – Signs and symptoms of pneumonitis may include: new or worsening cough, shortness of breath, or chest pain
  • Liver Problems (hepatitis) – Signs and symptoms of hepatitis may include: yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, feeling less hungry than usual
  • Intestinal Problems (colitis) – Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual, blood in the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
  • Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) Signs and symptoms that the hormone glands are not working properly may include: headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness, feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain
  • Nervous System Problems (neuropathy, meningoencephalitis) Signs of nervous system problems may include: severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, neck stiffness
  • Inflammation of the Eyes – Symptoms may include blurry vision, double vision, other vision problems, eye pain or redness
  • Severe Infections – Symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, pain when urinating
  • Severe Infusion Reactions – Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, facial swelling

 

The most common side effects of TECENTRIQ include:

· feeling tired

· decreased appetite

  • nausea

· urinary tract infection

  • fever
  • constipation

These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.

 

Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:

· have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system, such as Myasthenia Gravis or Guillain-Barre syndrome; or are being treated for an infection.

· are pregnant or plan to become pregnant.

o TECENTRIQ can harm an unborn baby.

o If patients are able to become pregnant, they should use an effective method of birth control during treatment and for at least 5 months after the last dose of TECENTRIQ.

· are breastfeeding or plan to breastfeed.

o It is not known if TECENTRIQ passes into the breast milk.

o Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ.

Patients should tell their healthcare provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

 

Report side effects to the FDA at (800) FDA-1088, or http:// www.fda.gov/medwatch . Report side effects to Genentech at (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, nine 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/immunotherapy.

About Genentech

Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or 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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