Genentech’s Tecentriq Combined with Lurbinectedin Shows Significant Survival Benefit in Extensive-Stage Small Cell Lung Cancer

– 46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options –

– First Phase III study in ES-SCLC first-line maintenance to demonstrate clinically meaningful improvements in both progression-free and overall survival –

– Data are being presented in an oral session at the 2025 ASCO Annual Meeting and simultaneously published in The Lancet –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III IMforte study of Tecentriq^® (atezolizumab) in combination with lurbinectedin (Zepzelca^®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq. The data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Safety was consistent with the known safety profiles of Tecentriq and lurbinectedin. These data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet.

“Small cell lung cancer is an aggressive and devastating disease. At the time of diagnosis, the large majority of patients have already progressed to extensive-stage disease and only one out of five survive longer than two years,” said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. “The IMforte results are very encouraging showing a potentially practice-changing option that could improve survival for patients with a very high unmet need.”

“In the IMforte study, the Tecentriq and lurbinectedin maintenance regimen significantly extended survival for people living with extensive-stage small cell lung cancer,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “This study builds on Tecentriq’s well-established safety and efficacy profile as the first immunotherapy for this cancer type and may provide another approach to help physicians and patients better manage this aggressive disease.”

Patients in the IMforte study first completed four cycles of Tecentriq combined with chemotherapy, over the course of approximately three months, before being randomized into maintenance treatment. From the point of randomization, the median overall survival (OS) for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). No new safety signals were observed.

About the IMforte study

IMforte [NCT05091567] is a Phase III, open-label, randomized trial evaluating the efficacy and safety of Tecentriq^® (atezolizumab) plus lurbinectedin versus Tecentriq alone as first-line maintenance therapy for adults (≥18 years) with extensive-stage small-cell lung cancer (ES-SCLC). Patients first received induction therapy with Tecentriq, carboplatin and etoposide for four 21-day cycles. Those without disease progression were then randomized 1:1 to receive maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone until disease progression or unacceptable toxicity. The study enrolled 660 patients in the induction phase and randomized 483 patients in the maintenance phase. The study’s primary endpoints were independent review facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS) from randomization into the maintenance phase.

The trial is sponsored by Genentech and co-funded by Jazz Pharmaceuticals.

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.

Important Safety Information and Indications

Tecentriq is a prescription medicine used to treat:

Adults with a type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:

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

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

• In children for the treatment of SCLC.

What is the most important information about Tecentriq?

Tecentriq 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 worse 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 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. Call or see your 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 you underwent transplantation either before or after being treated with Tecentriq. 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. 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 if you have severe side effects.

Before you receive Tecentriq, 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 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 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. Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq.
  • You should use an effective method of birth control during your 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 your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.

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 in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

Tecentriq 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. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

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 and Medication Guide for additional Important Safety Information.

About Genentech in cancer immunotherapy

To learn more about Genentech’s scientific-led approach to cancer immunotherapy, please follow this link: https://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.

All trademarks used or mentioned in this release are protected by law.

ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.

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