Genentech’s Alecensa Delivers Unprecedented Phase III Results for People With ALK-Positive Early-Stage Lung Cancer

– ALINA data demonstrate Alecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced setting –

– About half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cure –

– These data will be submitted to health authorities globally and presented at an upcoming medical meeting –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase III ALINA study evaluating Alecensa^® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected Stage IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Alecensa is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death for people with early-stage ALK-positive NSCLC in a Phase III trial.

Overall survival (OS) data were immature at the time of this analysis. No unexpected safety findings were observed. Results from the ALINA study will be presented at an upcoming medical meeting and submitted to health authorities globally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC, and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure, which is our ultimate goal at Genentech. We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.”

Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy. Recent treatment innovations, including immunotherapies, have improved the outlook for some patients with early-stage NSCLC; however, there are no approved ALK inhibitors for early-stage ALK-positive disease. Approximately five percent of people with NSCLC are ALK positive. ALK-positive NSCLC is often found in younger people – usually 55 and under – who have a light or non-smoking history. National Comprehensive Cancer Network^® (NCCN^®) Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommend biomarker testing of resected surgical tissue or biopsy for ALK rearrangements in patients with Stage IB to IIIA and IIIB NSCLC, in addition to in the advanced setting.

About the ALINA study

The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant Alecensa^® (alectinib) compared with platinum-based chemotherapy in people with completely resected Stage IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study includes 257 patients who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is disease-free survival (DFS). Secondary outcome measures include overall survival (OS) and percentage of patients with adverse events.

About lung cancer

According to the American Cancer Society, it is estimated that more than 238,000 Americans will be diagnosed with lung cancer in 2023, and NSCLC accounts for 80-85% of all lung cancers. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

About Alecensa^® (alectinib)

Alecensa is a prescription medicine used to treat people with non-small cell lung cancer that has spread to other parts of the body (mNSCLC) and is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. A doctor will perform a test to make sure that Alecensa is right for their patient.

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

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 then 1 time each month 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. Patients should tell their healthcare provider right away if they have a change in the amount or color of their urine, or if they get new or worsening swelling in their 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.

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take Alecensa. If this happens, patients may not have enough healthy red blood cells. Doctors may temporarily stop Alecensa and do blood tests, if needed, to check for this problem. If patients develop hemolytic anemia, their doctor may either restart them on Alecensa at a lower dose when the hemolytic anemia goes away, or may stop treatment with Alecensa. Patients should tell their doctor right away if they experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

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 Alecensa
  • Men 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 Alecensa
• Are 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, face, and eyelids
• Muscle pain, tenderness, and weakness (myalgia)
• 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 1-800-FDA-1088 or http://www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at 1-888-835-2555.

Please see additional Important Safety Information in full Prescribing Information, 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 six 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. Genentech is committed to improving treatment of early-stage lung cancers to help increase the chance of cure for more people.

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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