SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 16, 2018--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced follow-up data from the Phase III ALEX study, showing that as an initial treatment Alecensa ® (alectinib) significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 57 percent (hazard ratio [HR]= 0.43, 95 percent CI: 0.32-0.58) compared to crizotinib after two years of follow-up in people with anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC), as assessed by the investigator. The median PFS for people who received Alecensa was more than tripled compared to those who received crizotinib (34.8 months [95 percent CI: 17.7 months-NE] versus 10.9 months [95 percent CI: 9.1-12.9]), respectively, as assessed by the investigator. The safety profile for Alecensa was consistent with that observed in previous studies.

“Follow-up results from the ALEX study demonstrate the significant sustained benefit of Alecensa, showing that people with metastatic ALK-positive non-small cell lung cancer lived for almost three years without their disease progressing,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These results further support the use of Alecensa as a standard of care for people who are newly diagnosed with this form of lung cancer.”

The longer-term analysis also included follow-up data for secondary endpoints of the ALEX study. Alecensa demonstrated superior efficacy compared to crizotinib regardless of the presence of central nervous system (CNS) metastases at baseline. Investigator-assessed median PFS for people without CNS metastases at baseline was 34.8 months with Alecensa (95 percent CI: 22.4-NE) versus 14.7 months (95 percent CI: 10.8-20.3) with crizotinib (HR=0.47, 95 percent CI: 0.32-0.71). Investigator-assessed median PFS for people with CNS metastases at baseline was 27.7 months in the Alecensa arm (95 percent CI: 9.2-NE) versus 7.4 months (95 percent CI: 6.6-9.6) in the crizotinib arm (HR=0.35, 95 percent CI: 0.22-0.56). The duration of response (DOR) for people who received Alecensa was 33.3 months (95 percent CI: 31.3-NE) compared to 11.1 months (95 percent CI: 7.5-13.0 months) for people who received crizotinib.

The data will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, June 3, 2018, at 8:00 – 11:30 a.m. CDT (Abstract #9043).

Alecensa is approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

About the ALEX study

ALEX (NCT02075840/B028984) is a randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in treatment-naïve people with ALK-positive NSCLC whose tumors were characterized as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomized (1:1) to receive either Alecensa or crizotinib. The primary endpoint of the ALEX study was PFS as assessed by the investigator, and secondary endpoints include: Independent Review Committee (IRC)-assessed PFS, time to CNS progression, objective response rate (ORR), DOR and overall survival (OS). The multicenter study was conducted in 303 people across 161 sites in 31 countries. OS data are currently considered immature with only about a third of events being reported.

Primary data from the ALEX study were previously presented at the 2017 ASCO Annual Meeting and published in the New England Journal of Medicine. Follow-up results from the ALEX study analysis to be presented at the 2018 ASCO Annual Meeting showed:

After a further 10 months of follow-up, Alecensa reduced the risk of disease worsening or death (PFS) by 57 percent compared to crizotinib (HR=0.43, 95 percent CI: 0.32-0.58). Median follow-up was 27.8 months versus 22.8 months for Alecensa-treated patients and crizotinib-treated patients, respectively. Investigator-reported median PFS (the primary endpoint) was 34.8 months in the Alecensa arm (95 percent CI: 17.7-NE) versus 10.9 months (95 percent CI: 9.1-12.9 months) in the crizotinib arm. ORR for people treated with Alecensa was 82.9 percent (95 percent CI: 75.95-88.51) compared to 75.5 percent (95 percent CI: 67.84-82.12) for people treated with crizotinib, as assessed by the investigator. Alecensa demonstrated superior efficacy compared to crizotinib regardless of the presence or absence of CNS metastases at baseline. Investigator-assessed median PFS for people without CNS metastases at baseline was 34.8 months with Alecensa (95 percent CI: 22.4-NE) versus 14.7 months (95 percent CI: 10.8-20.3) with crizotinib (HR=0.47, 95 percent CI: 0.32-0.71). Investigator-reported median PFS for people with CNS metastases at baseline was 27.7 months in the Alecensa arm (95 percent CI: 9.2-NE) versus 7.4 months (95 percent CI: 6.6-9.6) in the crizotinib arm (HR=0.35, 95 percent CI: 0.22-0.56). Improvements were observed in the time between first response to treatment and disease worsening (DOR): 33.3 months with Alecensa versus 11.1 months with crizotinib. Grade 3-5 adverse events (AEs) were less frequent in the Alecensa arm (44.7 percent) compared to the crizotinib arm (51.0 percent). The most common Grade 3-4 AEs were increased liver enzymes (aspartate transaminase; 5.5 percent, and alanine transaminase; 4.6 percent) and increased muscle enzymes (creatine phosphokinase; 3.3 percent). Serious adverse reactions reported in ≥ 2 percent of people treated with Alecensa were acute kidney injury (2.6 percent) and decreased red blood cells (anemia; 2.0 percent). AEs leading to dose reduction (16.4 percent versus 20.5 percent) and dose interruption (22.4 percent versus 25.2 percent) were lower in the Alecensa arm compared with the crizotinib arm. AEs leading to discontinuation were equal in both arms (13.2 percent).

The FDA approval of Alecensa for the treatment of people with ALK-positive metastatic NSCLC was based on results from the Phase III ALEX study from the primary data cutoff in February 2017. Results showed that:

Alecensa significantly reduced the risk of disease worsening or death (PFS) by 47 percent (HR=0.53, 95 percent CI: 0.38, 0.73, p<0.0001) compared to crizotinib as assessed by an IRC. The median PFS was 25.7 months (95 percent CI: 19.9, NE) for people who received Alecensa compared with 10.4 months (95 percent CI: 7.7-14.6) for people who received crizotinib as assesed by an IRC. Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or CNS compared to crizotinib by 84 percent (HR=0.16, 95 percent CI: 0.10, 0.28, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12 percent) compared to people who received crizotinib (45 percent). The safety profile of Alecensa was consistent with that observed in previous studies. Grade ≥ 3 adverse reactions were reported for 41 percent of people treated with Alecensa. The most common Grade 3-4 adverse reactions (≥ 3 percent) were evidence of kidney dysfunction (increased creatinine; 4.1 percent), evidence of liver dysfunction (hyperbilirubinemia; 5 percent), low levels of sodium (hyponatremia; 6 percent), increased liver enzymes (aspartate transaminase; 6 percent, and alanine transaminase; 6 percent), and decreased red blood cells (anemia; 7 percent). Serious adverse reactions reported in ≥ 2 percent of people treated with Alecensa were pneumonia (4.6 percent) and renal impairment (3.9 percent).

About lung cancer

According to the American Cancer Society, it is estimated that more than 234,000 Americans will be diagnosed with lung cancer in 2018, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.

About Alecensa ® (alectinib)

Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Alecensa U.S. Indication

Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

A doctor may lower the dose or stop treatment with Alecensa if any serious side effects occur.  Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity).  Alecensa may cause liver injury. A doctor will do blood tests at least every 2 weeks for the first 3 months and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:

Feeling tired Feeling less hungry than usual Yellowing of the skin or whites of the eyes Dark urine Itchy skin Nausea or vomiting Pain on the right side of stomach area Bleeding or bruising more easily than normal

Lung problems.  Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including:

Trouble breathing Shortness of breath Fever Cough

Kidney problems.  Alecensa may cause severe or life-threatening kidney problems. Tell your healthcare provider right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.

Slow heartbeat (bradycardia).  Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Muscle pain, tenderness, and weakness (myalgia).  Muscle problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Before taking Alecensa, patients should tell their doctor about all medical conditions, including if they:

Have liver problems Have lung or breathing problems Have a slow heartbeat Are pregnant or plan to become pregnant. Alecensa can harm an unborn baby. Patients taking Alecensa should tell their doctor right away if they become pregnant during treatment with Alecensa or think they may be pregnant Women  who are able to become pregnant should use effective birth control during treatment with Alecensa and for one week after the final dose of AlecensaMen  who have female partners that are able to become pregnant should use effective birth control during treatment with Alecensa and for three months after the final dose of AlecensaAre breastfeeding or plan to breastfeed. It is not known if Alecensa passes into breast milk. A patient should not breastfeed during treatment with Alecensa and for one week after the final dose of Alecensa. Patients should talk with their doctor about the best way to feed their baby during this time.

Patients taking Alecensa should tell their doctor about all the medicines they take, including  prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Patients taking Alecensa should avoid spending time in the sunlight during treatment with Alecensa and for seven days after the final dose of Alecensa. Patients taking Alecensa may burn more easily and get severe sunburns. Patients taking Alecensa should use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

Tiredness Constipation Swelling in hands, feet, ankles, and eyelids Low red blood cell count

These are not all of the possible side effects of Alecensa. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or  . Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full  , including Patient Information.

About Genentech in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

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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PUB: 05/16/2018 05:00 PM/DISC: 05/16/2018 05:01 PM

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