Genentech to Present New Data on 27 Different Medicines at ASCO

  • Genentech to deliver new data on approved medicines, investigational targeted combinations and the emerging pipeline
  • Data in more than 19 tumor types will be presented, including new results from the investigational cancer immunotherapy MPDL3280A (anti-PDL1) in advanced bladder cancer and the BCL-2 inhibitor GDC-0199/ABT-199 in hematology
2014 ASCO Annual Meeting

SOUTH SAN FRANCISCO, Calif.--()--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data on nine approved and 18 investigational medicines will be presented during the 50th American Society of Clinical Oncology (ASCO) Annual Meeting. Of the more than 320 abstracts on Genentech medicines, more than 40 have been accepted for oral presentation.

“Since the first ASCO Annual Meeting 50 years ago, we are proud to have contributed practice-changing advances for people with a broad range of tumors including breast, blood, colorectal, lung, and skin cancers,” said Sandra Horning M.D., chief medical officer and head of Global Product Development. “Data from nine approved and 18 investigational medicines, such as our anti-PDL1 immunotherapy, at ASCO this year demonstrate our continued commitment to improve outcomes for people with cancer.”

The data to be presented at ASCO show the depth and strength of Genentech’s oncology pipeline and include the following highlights:

Cancer Immunotherapy: A Phase I study of anti-PDL1 in advanced bladder cancer will be presented in an oral session on Saturday, May 31. The presentation will feature important updates including: overall response rate, biomarker data and safety information. As part of Genentech’s global development plan to explore the potential of multiple immunotherapy targets in oncology, anti-PDL1 represents the company’s most advanced investigational cancer immunotherapy in development.

Hematology: In addition to data from the anti-CD20 medicines Rituxan® (rituximab) and GazyvaTM (obinutuzumab), new data from two investigational medicines will be presented for the first time at ASCO. These data include interim results of a Phase Ib study of the BCL-2 inhibitor GDC-0199/ABT-199 in combination with Rituxan in patients with relapsed/refractory chronic lymphocytic leukemia and results of a Phase II study of polatuzumab vedotin, an anti-CD79b antibody-drug conjugate, in relapsed/refractory non-Hodgkin’s lymphoma.

Overview of key presentations featuring Genentech medicines:

 

Medicine   Description of study   Abstract number
MPDL3280A (anti-PDL1) (investigational)   Inhibition of PD-L1 by MPDL3280A in patients with metastatic urothelial bladder cancer.   Abstract #5011
Avastin® (bevacizumab)   CALGB/SWOG 80405: Findings from a Phase III study comparing chemotherapy in combination with bevacizumab or cetuximab - in first-line treatment of metastatic colorectal cancer without KRAS mutations.   Abstract #LBA3
Avastin +Tarceva®

(erlotinib) (investigational)

 

Erlotinib plus bevacizumab versus erlotinib alone as first-line treatment for advanced EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC): An open-label randomized trial.

  Abstract #8005
Erivedge® (vismodegib)   Long-term safety profile and efficacy of vismodegib in patients with advanced basal cell carcinoma: Final update (30-month) of the pivotal ERIVANCE BCC study.   Abstract #9013

GDC-0199/ABT-199 (investigational)

 

GDC-0199/ABT-199 combined with rituximab in patients with relapsed/refractory chronic lymphocytic leukemia: Interim results of a Phase Ib study.

  Abstract #7013

Polatuzumab vedotin (anti-CD79b antibody-drug conjugate) and pinatuzumab vedotin (anti-CD22 antibody-drug conjugate) (investigational)

  Preliminary results of a Phase II randomized study (ROMULUS) of polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed/refractory non-Hodgkin’s lymphoma.   Abstract #8519
Zelboraf (investigational)   VE-BASKET, a first-in-kind, Phase II, histology-independent “basket” study of vemurafenib in non-melanoma solid tumors harboring BRAF V600 mutations.   Abstract #2533
Zelboraf + cobimetinib (investigational)   Metabolic tumor burden for prediction of overall survival following combined BRAF/MEK inhibition in patients with advanced BRAF mutant melanoma.   Abstract #9006
   

2014 marks the 50-year anniversary of ASCO. Since the first ASCO Annual Meeting in 1964, Roche and Genentech medicines have been discussed in thousands of data presentations, including eight plenary presentations since 2010, representing a significant contribution for people with many forms of cancer.

Visit http://www.gene.com/asco for perspectives from Genentech executives on topics of interest at ASCO, including immunotherapy, lung cancer and quality of care.

About Avastin

Indication

Avastin is approved for first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Avastin, in combination with fluropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen. Avastin is not indicated for adjuvant treatment of colon cancer.

Avastin is approved for first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel.

Important Safety Information

BOXED WARNINGS and Additional Important Safety Information

People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:

Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this event occurred in more people who received Avastin than in the comparison group (up to 2.4 percent). In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs.

Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with metastatic colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15 percent for patients who received Avastin and four percent for patients who did not receive Avastin.

Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined. Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that require medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing.

Severe bleeding: Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.

In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.6 percent of people. Too much protein in the urine that led to kidney problems was seen in less than one percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in five percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than three percent of people, and severe reactions occurred in 0.2 percent of people. Avastin can cause fertility issues for women. Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children.

Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.

Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin.

Women should be advised to discontinue nursing or discontinue treatment with Avastin, taking into account the importance of Avastin to the mother.

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.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

About Erivedge

Indication

Erivedge capsule is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.

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

Important Safety Information

Erivedge can cause a baby to die before it is born (be stillborn) or cause a baby to have severe birth defects.

  • For females who can become pregnant, they must talk with their healthcare provider about the risks of Erivedge to their unborn child. Their healthcare provider should do a pregnancy test within seven days before the patient starts taking Erivedge to find out if the patient is pregnant. Patients must avoid pregnancy by using highly effective birth control before starting Erivedge, and continue during treatment and for seven months after their last dose. Patients must tell their healthcare provider right away if they have unprotected sex or think that their birth control has failed.
  • For males, they must always use a condom with a spermicide during sex with female partners while they are taking Erivedge and for two months after their last dose, even if they have had a vasectomy.
  • Patients must tell their healthcare provider right away if they or their female partner could be pregnant or thinks she is pregnant while they are taking Erivedge.

Exposure to Erivedge during pregnancy:

Pregnant women are encouraged to participate in a program that collects information about exposure and the effects on the mother and her unborn child by calling the Genentech Adverse Event Line at (888) 835-2555.

Patients must tell their healthcare provider before taking Erivedge if

  • they are pregnant or plan to become pregnant
  • if they are breastfeeding or plan to breastfeed

Patients must not donate blood or blood products while they are taking Erivedge and for seven months after their last dose.

The most common side effects of Erivedge are: muscle spasms, hair loss, change in how things taste or loss of taste, weight loss, tiredness, nausea, diarrhea, decreased appetite, constipation, vomiting and joint aches.

These are not all the possible side effects of Erivedge. For more information, patients should ask their healthcare provider or pharmacist.

Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away.

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

Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and the Medication Guide for serious side effects and additional important safety information at http://www.erivedge.com.

About Tarceva

Indication

Tarceva is approved as a first-line treatment, maintenance treatment, and second- or third-line treatment for advanced-stage non-small cell lung cancer (NSCLC).

  • Tarceva is prescribed as initial treatment for patients with NSCLC, whose cancer has spread to other parts of the body and that has certain types of Epidermal Growth Factor Receptor (EGFR) mutations. (First-line treatment)
  • Tarceva is prescribed as maintenance treatment for advanced-stage NSCLC in patients whose cancer has not spread or grown after prior treatment with certain types of chemotherapy.
  • Tarceva is prescribed as second- or third-line treatment for advanced-stage NSCLC in patients whose cancer has spread or grown after receiving at least one round of chemotherapy.
  • Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
  • For initial treatment with NSCLC whose cancer has not spread to other parts of the body, it is not known if Tarceva is safe and effective in other EGFR mutations.

Important Safety Information

The following serious adverse reactions, which include deaths, were reported in patients taking Tarceva: Interstitial Lung Disease (ILD) events; liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); serious skin conditions; blood, bleeding and clotting problems (heart attack or stroke); eye disorders (dry eyes, eye irritation, and damage to the cornea); bleeding events when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs); pregnancy (women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva).

Patients should call their doctor right away if they have these signs or symptoms: Serious or ongoing diarrhea, nausea (feeling sick to the stomach), loss of appetite, or vomiting; new or worsening shortness of breath or cough; eye irritation; new or worsening rash, blistering or peeling of the skin; any changes in smoking habits.

The most common side effects include:

  • First-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, and loss of appetite.
  • Maintenance/Second- or Third-Line NSCLC treatment: Rash and diarrhea.

Patients should call their doctor for medical advice about side effects.

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 see the full Prescribing Information for additional important safety information at http://www.tarceva.com.

About Zelboraf

Indication

Zelboraf is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene.

A patient’s healthcare provider will perform a test to make sure that Zelboraf is right for the patient. Zelboraf is not used to treat melanoma with a normal BRAF gene.

Important Safety Information

Zelboraf can cause serious side effects, including risk of cancers. Zelboraf may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have occurred in people who take Zelboraf. Zelboraf may also cause another type of cancer called non-cutaneous squamous cell carcinoma (SCC). Patients must talk with their healthcare provider about their risk for these cancers. Patients must check their skin and tell their doctor about skin changes including a new wart, a sore or bump that bleeds or does not heal, or a mole that changes size or color.

A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients must tell their healthcare provider about any new symptoms that they get while taking Zelboraf.

While taking Zelboraf, patients should avoid sunlight. When they go outside, patients must wear clothes that protect their skin, including their head, face, hands, arms and legs. Patients must use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

Possible serious side effects of Zelboraf include severe allergic reactions, severe skin reactions, potentially life-threatening changes in the electrical activity of the heart called QT prolongation, abnormal liver function tests and eye problems. Patients must tell their doctor if they are pregnant or plan to become pregnant as Zelboraf can harm a patient’s unborn baby.

Common side effects of Zelboraf include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching or warts.

Patients must tell their doctor if they have any side effect that bothers them or does not go away. These are not all of the possible side effects of Zelboraf. For more information about side effects, patients should ask their doctor or pharmacist.

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.

Patients should read the full Prescribing Information and Medication Guide for additional important safety information at http://www.zelboraf.com.

About Genentech

Founded more than 35 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.

Contacts

Genentech
Media Contact:
Krysta Pellegrino, 650-467-6800
Advocacy Contact:
Sonali Chopra, 650-467-0842
Investor Contacts:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503

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Contacts

Genentech
Media Contact:
Krysta Pellegrino, 650-467-6800
Advocacy Contact:
Sonali Chopra, 650-467-0842
Investor Contacts:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503