FDA Approves Genentech?s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of People With a Specific Type of Metastatic Lung Cancer
Approval based on survival benefit of Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), in people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations compared to Avastin plus chemotherapy
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq??(atezolizumab), in combination with Avastin? (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
?This Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer,? said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ?Today?s approval supports our combination approach for Tecentriq in lung cancer and our vision to develop medicines that improve outcomes for patients with this complex disease.?
This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer compared to Avastin and chemotherapy (median overall survival [OS] = 19.2 versus 14.7 months; hazard ratio [HR] = 0.78; 95 percent CI: 0.64-0.96; p=0.016) in the intention-to-treat wild-type (ITT-WT) population. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.
Genentech is working with the FDA on postmarketing commitments (PMCs) to better understand and characterize the potential effects of Tecentriq-related anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) across all of our studies. An analysis of ADAs in the IMpower150 study showed no impact on the efficacy of Tecentriq.
Tecentriq is also approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK genetic alterations.
For those who qualify, Genentech offers patient assistance programs for people taking Tecentriq through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (866) 422-2377. More information is also available at http://www.Genentech-Access.com.
About the IMpower150 study
IMpower150 is a multicenter, open-label, randomized, controlled Phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with Stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people, of whom 1,045 were in the ITT-WT subpopulation, which excluded those people with EGFR and ALK mutations. People were randomized (1:1:1) to receive:
- Tecentriq plus carboplatin and paclitaxel (Arm A), or
- Tecentriq and Avastin plus carboplatin and paclitaxel (Arm B), or
- Avastin plus carboplatin and paclitaxel (Arm C, control arm).
- Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer compared to Avastin and chemotherapy (median OS=19.2 versus 14.7 months; HR=0.78, 95 percent CI: 0.64-0.96; p=0.016).
- In addition, Tecentriq in combination with Avastin and chemotherapy reduced risk of disease worsening or death (PFS) by 29 percent compared to Avastin and chemotherapy (HR=0.71, 95 percent CI: 0.59-0.85, p=0.0002).
- Tecentriq in combination with Avastin and chemotherapy shrank tumors (overall response rate; ORR) in 55 percent of people (95 percent CI: 49-60) compared to 42 percent of people (95 percent CI: 37-48) on Avastin and chemotherapy.
- 4 percent of people receiving Tecentriq in combination with Avastin and chemotherapy experienced a complete response (CR), and 51 percent of people experienced a partial response (PR).
- The median duration of response (DoR) for people receiving Tecentriq in combination with Avastin and chemotherapy was 10.8 months (95 percent CI: 8.4-13.9) compared to 6.5 months (95 percent CI: 5.6-7.6) for people on Avastin and chemotherapy.
- The most common adverse reactions (=20 percent) in people receiving Tecentriq in combination with Avastin and chemotherapy were fatigue and lack of energy (asthenia; 50 percent), hair loss (alopecia; 48 percent), nausea (39 percent), diarrhea (32 percent), constipation (30 percent), decreased appetite (29 percent), joint pain (arthralgia; 26 percent), hypertension (25 percent) and pain from nerve damage (peripheral neuropathy; 24 percent).
- 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 doctor has tested your cancer and found high levels of a specific protein on your cancer called programmed death-ligand 1 (PD-L1), or
- you are not able to take chemotherapy that contains any platinum regardless of the levels of PD-L1 on your cancer, or
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working
- 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
- your tumor does not have an abnormal ?EGFR? or ?ALK? gene
- Tecentriq may be used 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.
- Lung problems (pneumonitis) ?signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain
- Liver problems (hepatitis) ?signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and 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 or mucus in your stools or dark, tarry, sticky stools ,?and severe stomach area (abdomen) pain or tenderness
- ?Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)? ?signs and symptoms that your 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, your voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
- Problems in other organs ?signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
- Severe infections ?signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
- Severe infusion reactions ?signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of your face or lips, dizziness, fever, feeling like passing out, and back or neck pain
- 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. 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:?
- A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
- They 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 the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
- feeling tired
- nausea
- constipation
- cough
- shortness of breath
- decreased appetite
- feeling tired or weak
- hair loss
- nausea
- diarrhea
- constipation
- decreased appetite
- joint pain
- high blood pressure
- tingling or numbness in hands and feet
- Metastatic colorectal cancer (mCRC) for first- or second-line treatment in combination with intravenous 5-fluorouracil?based chemotherapy. It is also approved to treat mCRC for second-line treatment, when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy, after cancer progresses following a first-line treatment that includes Avastin.
- Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body
- Advanced nonsquamous non?small cell lung cancer (NSCLC)? in combination with carboplatin and paclitaxel, in people who have not received chemotherapy for their advanced disease
- Metastatic kidney cancer (mRCC) when used with interferon alfa
- Glioblastoma (GBM) in adult patients whose cancer has progressed after prior treatment (recurrent or rGBM)
- Advanced cervical cancer (CC) in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix
- Ovarian cancer (OC).? Avastin, in combination with carboplatin and paclitaxel, followed by Avastin alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgery.
- GI perforation. A hole that develops in the stomach or intestine. Symptoms include pain in the abdomen, nausea, vomiting, constipation, or fever
- Wounds that don?t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
- Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If a patient has recently coughed up blood or had serious bleeding, they should be sure to tell their doctor
- Abnormal passage in the body. This type of passage?known as a fistula?is an irregular connection from one part of the body to another and can sometimes be fatal
- Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
- Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
- Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. The patient?s doctor or nurse will monitor for signs of infusion reactions
- Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and the heart may become too weak to pump blood to other parts of the body (congestive heart failure). These can sometimes be fatal
- Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness
- High blood pressure
- Too much protein in the urine
- Nosebleeds
- Rectal bleeding
- Back pain
- Headache
- Taste change
- Dry skin
- Inflammation of the skin
- Inflammation of the nose
- Watery eyes
- Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
- Pregnant or think they are pregnant. Data have shown that Avastin may harm a woman?s unborn baby. Birth control should be used while patients are on Avastin. If Avastin is stopped, patients should keep using birth control for 6 months before trying to become pregnant
- Planning to become pregnant. Taking Avastin could cause a woman?s ovaries to stop working and may impair her ability to have children
- Breastfeeding. Breastfeeding while on Avastin may harm the baby and is therefore not recommended during and for 6 months after taking Avastin
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