FDA Approves Genentech’s Tecentriq in Combination With a Fluoropyrimidine and Oxaliplatin for the Adjuvant Treatment of a Certain Type of Stage III Colon Cancer

The approval adds a twelfth U.S. indication for Tecentriq.

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• FDA approval is based on results from the landmark Phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone
• First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care
• Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years
• Approval marks the twelfth indication for Tecentriq in the U.S.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq^® (atezolizumab) and Tecentriq Hybreza^® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterized by high mutation rates. This approval marks the twelfth indication for Tecentriq in the U.S.

“This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.”

“Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator for the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death.”

The FDA approval is based on the landmark Phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA^® MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6.

Colon cancer remains one of the world's most common and deadliest tumors. Over one million people are diagnosed globally each year, and nearly 25% of all colon cancers are diagnosed at stage III. Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years. Approximately 15% of colon cancer patients present with dMMR or microsatellite instability-high (MSI-H) tumors, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.

About the ATOMIC study

ATOMIC (A021502, NCT02912559) is a Phase III, randomized, open-label, multicenter study investigating the addition of Tecentriq^® (atezolizumab) to mFOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomized 1:1 to receive either mFOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or mFOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS).

The global study in the U.S. was sponsored by the U.S. National Cancer Institute (NCI), part of the National Institutes of Health, and led by the Alliance for Clinical Trials in Oncology (Alliance) with participation from other NCI-funded National Clinical Trials Network (NCTN) groups. Genentech provided support for the study through a Cooperative Research and Development Agreement between NCI and Genentech. The trial was led globally by Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator within the Alliance. German participation in this major international academic collaboration was enabled through close cooperation between the Alliance and the AIO-Studien-gGmbH, in partnership with the AIO (Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society (Deutsche Krebsgesellschaft, DKG), under the national leadership of Prof. Dr. Anke Reinacher-Schick (Ruhr-Universität Bochum). AIO-affiliated study sites enrolled patients during the later recruitment phase, ensuring access for eligible patients in Germany.

About Tecentriq^® (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is 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 has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.

What are Tecentriq and Tecentriq Hybreza?

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:

Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

• Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer:
  • to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and
  • you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and
  • your cancer tests positive for “PD-L1”.
• Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer:
  • has spread or grown, and
  • your cancer tests positive for “high PD-L1”, and
  • your tumor does not have an abnormal “EGFR” or “ALK” gene.
• Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer:
  • has spread or grown, and
  • is a type called “non-squamous NSCLC”, and
  • your tumor does not have an abnormal “EGFR” or “ALK” gene.
• Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer:
  • has spread or grown, and
  • is a type called “non-squamous NSCLC”, and
  • your tumor does not have an abnormal “EGFR” or “ALK” gene.
• Tecentriq or Tecentriq Hybreza 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.
  • 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.

Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown

• Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
• Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
  • has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide.

Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer:

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

Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma:

• has spread to other parts of the body or cannot be removed by surgery, and
• has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you.

Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma:

• has spread to other parts of the body or cannot be removed by surgery.

Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer:

• to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and
• small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you.

Adults and children with a type of colon cancer (Tecentriq is for children 2 years of age and older; Tecentriq Hybreza is for children 12 years of age and older and who weigh 88 pounds (40kg) or more). Tecentriq or Tecentriq Hybreza may be used with a fluoropyrimidine and oxaliplatin medicine:

• to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and
• you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR).

It is not known if Tecentriq Hybreza is safe and effective when used:

• in children younger than 12 years of age for the treatment of ASPS or colon cancer.
• in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC.

It is not known if Tecentriq is safe and effective when used:

• in children younger than 2 years of age for the treatment of ASPS or colon cancer.
• in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC.

Important Safety Information

Who should not receive Tecentriq Hybreza?

Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza.

What is the most important information about Tecentriq and Tecentriq Hybreza?

Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems

• cough
• shortness of breath
• chest pain

Intestinal problems

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

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
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

• decrease in your amount of urine
• blood in your urine
• swelling of your ankles
• loss of appetite

Skin problems

• rash
• itching
• skin blistering or peeling
• painful sores or ulcers in your mouth or your 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 or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening 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

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

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 you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects.

Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you:

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

Tell your healthcare provider about all the medicines you 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
• decreased appetite
• nausea
• cough
• shortness of breath

The most common side effects of Tecentriq Hybreza when used alone include:

• feeling tired or weak
• muscle or bone pain
• cough
• shortness of breath
• decreased appetite

The most common side effects of Tecentriq and Tecentriq Hybreza 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 and Tecentriq Hybreza 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 and Tecentriq Hybreza 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

The most common side effects of Tecentriq and Tecentriq Hybreza when used in colon cancer with chemotherapy include:

• feeling tired or weak
• nausea
• numbness, tingling, or pain in the hands or feet (neuropathy)
• constipation
• cough or shortness of breath
• fever
• stomach-area (abdominal) pain
• diarrhea
• decreased appetite
• mouth sores (stomatitis)
• change in sense of taste

The most common side effect of Tecentriq and Tecentriq Hybreza when used alone in MIBC is:

• urinary tract infection

Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza.

You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information.

About Genentech in Oncology

For more than 30 years, Genentech has pioneered oncology breakthroughs and is working to build a future where people with cancer can thrive, in spite of their diagnosis. With our therapies, we are intercepting disease where there is potential to deliver the best outcomes, while striving for longer-term impact in hard-to-treat settings. Our therapies are designed for the real world—reducing treatment burden and ensuring innovative care reaches patients who need them most, wherever they are. By working in lockstep with the medical, scientific, and patient communities, we are shaping the next era of cancer care.

About Genentech

Founded 50 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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Source: Genentech