Genentech Provides Update on Tecentriq U.S. Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company has made the decision to voluntarily withdraw the U.S. accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1, as determined by a U.S. Food and Drug Administration (FDA)-approved test. Genentech made this decision following consultation with the FDA based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval program. This decision only impacts the mTNBC indication in the U.S. It does not affect other approved indications for Tecentriq in the U.S. and outside the U.S., including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq.

“TNBC remains the most challenging type of breast cancer to treat, which makes the decision to withdraw so difficult for us, as patients have had this medicine as an important option for more than two years,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We appreciate the opportunity to have been able to help people with mTNBC in the U.S. with Tecentriq through the accelerated approval process, which has brought many significant and novel therapies to patients. We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”

Tecentriq was granted accelerated approval by the FDA for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. Approval was based on the progression-free survival (PFS) results of the Phase III IMpassion130 study for people with mTNBC whose tumors express PD-L1 (≥1%). Continued approval for this indication was contingent upon the results of IMpassion131, the postmarketing requirement (PMR). This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. The results of both studies were discussed at the FDA Oncology Drugs Advisory Committee (ODAC), which voted 7 to 2 on April 27, 2021, in favor of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive mTNBC. Since then, Genentech has been working diligently with the FDA on a possible alternative PMR. However due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval. This led to the difficult decision to voluntarily withdraw the U.S. mTNBC indication.

Genentech will work with the FDA over the coming weeks to complete the withdrawal process. Genentech is notifying healthcare professionals in the U.S. about this withdrawal. Patients in the U.S. being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider. Patients, or their healthcare providers, who have questions or concerns about coverage, reimbursement, or out-of-pocket costs are encouraged to call the Genentech Patient Resource Center at (877) 436-3683 for assistance. Our patient support specialists can help answer questions, including insurance coverage and potential financial assistance options.

Genentech is committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first-in-class medicine approved for particularly difficult to treat cancers. Tecentriq’s extensive development program includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.

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. 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 in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

• They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for “PD-L1” or
• They are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status

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 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 alone as the first treatment in patients with lung cancer if:

• Their cancer has spread or grown, and
• Their cancer tests positive for “high PD-L1” and
• Their tumor does not have an abnormal “EGFR” or “ALK” gene.

Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

• Their cancer has spread or grown and
• Is a type of lung cancer called “non-squamous NSCLC” and
• Their tumor does not have an abnormal “EGFR” or “ALK” gene

Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

• Their cancer has spread or grown and
• Is a type of lung cancer called “non-squamous NSCLC” and
• Their tumor does not have an abnormal “EGFR” or “ALK” gene

Tecentriq may be used alone in patients with lung cancer if:

• Their cancer has spread or grown and
• They have tried chemotherapy that contains platinum, and it did not work or is no longer working
• If a patient’s tumor has an abnormal EGFR or ALK gene, they 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 in patients with TNBC when their breast cancer:

• Has spread or cannot be removed by surgery and
• Their 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 the results of an ongoing study to confirm benefit.

Tecentriq is not for use with the medicine paclitaxel (a different medicine than paclitaxel protein-bound) in patients with TNBC when their breast cancer has spread or cannot be removed by surgery.

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

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer:

• is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.

A type of liver cancer called hepatocellular carcinoma (HCC).

Tecentriq may be used with the medicine bevacizumab in patients with HCC if:

• Their cancer has spread or cannot be removed by surgery, and
• They have not received other medicines by mouth or injection through their vein (IV) to treat their cancer.

A type of skin cancer called melanoma.

Tecentriq may be used with the medicines cobimetinib and vemurafenib when in patients with melanoma when their skin cancer:

• has spread to other parts of the body or cannot be removed by surgery, and
• has a certain type of abnormal “BRAF” gene.

Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.

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

Important Safety Information

The most important information about Tecentriq is:

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 can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Lung problems

• Cough
• Shortness of breath
• Chest pain

Intestinal problems

• Diarrhea (loose stools) or more bowel movements than usual
• Blood or mucus in stools or dark, tarry, sticky stools
• Severe stomach area (abdomen) pain or tenderness

Liver problems

• 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 and feeling less hungry than usual

Hormone gland problems

• Headaches that will not go away or unusual headaches
• Eye sensitivity to light
• Eye problems
• Rapid heartbeat
• Increased sweating
• Extreme tiredness
• Weight gain or weight loss
• Feeling more hungry or thirsty than usual
• Urinating more often than usual
• Hair loss
• Feeling cold
• Constipation
• The voice gets deeper
• Dizziness or fainting
• Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

• Urinating less than usual
• Blood in the urine
• Swelling of ankles
• Loss of appetite

Skin problems

• Rash
• Itching
• Skin blistering or peeling
• Painful sores or ulcers in mouth or nose, throat, or genital area
• Fever or flu-like symptoms
• Swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

• Chills or shaking
• Itching or rash
• Flushing
• Shortness of breath or wheezing
• Dizziness
• Feeling like passing out
• Fever
• Back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be serious and can lead to death. These complications may happen if a patient underwent transplantation either before or after being treated with Tecentriq. A patient’s healthcare provider will monitor them for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. 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:

• Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus)
• Have had an organ transplant
• Have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• Have received radiation treatment to their chest area
• Have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome)
• Are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby.
  • Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq.
  • Females who are able to become pregnant:
    • Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq and
    • Should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
• Are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq

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 when used alone include:

• Feeling tired or weak
• Nausea
• Cough
• Shortness of breath
• Decreased appetite

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

• Feeling tired or weak
• Nausea
• Hair loss
• Constipation
• Diarrhea
• Decreased appetite

The most common side effects of Tecentriq when used in TNBC with paclitaxel protein-bound include:

• A decrease in hemoglobin (anemia)
• Decreased white blood cells
• Hair loss
• Tingling or numbness in hands and feet
• Feeling tired
• Nausea
• Diarrhea
• Constipation
• Cough
• Headache
• Vomiting
• Decreased appetite

The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include:

• High blood pressure
• Feeling tired or weak
• Too much protein in the urine

The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

• Skin rash
• Joint, muscle, or bone pain
• Feeling tired or weak
• Liver injury
• Fever
• Nausea
• Itching
• Swelling of legs or arms
• Mouth swelling (sometimes with sores)
• Low thyroid hormone levels
• Sunburn or sun sensitivity

Tecentriq may cause fertility problems in females, which may affect their 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 of Tecentriq.

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 Full Tecentriq Prescribing Information for additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://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.

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