Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following initial therapy with Tecentriq (or Tecentriq Hybreza), carboplatin, and etoposide (CE).
This approval marks a significant advance in the treatment of ES-SCLC, a rapidly progressing and aggressive form of lung cancer with historically limited options. It is the first and only combination therapy approved for first-line maintenance treatment in this setting. The decision underscores Genentech’s long-term commitment to improving outcomes for patients with difficult-to-treat cancers.
A Milestone for Patients With ES-SCLC
Small cell lung cancer accounts for about 15% of all lung cancer diagnoses, and most cases are identified at an extensive stage when the disease has already spread. While first-line chemotherapy and immunotherapy combinations can achieve initial responses, relapse is common, often within months.
The FDA’s approval of the Tecentriq and lurbinectedin regimen provides a new maintenance option designed to delay disease progression and extend survival following initial therapy. In parallel, the U.S. National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) to include the combination as a Category 2A and preferred regimen for maintenance therapy in patients with ES-SCLC who have completed induction therapy with Tecentriq and CE.
Expert Perspective
“For people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse,” said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and hematology at Yale Cancer Center and Smilow Cancer Hospital. “The Tecentriq and Zepzelca combination provides a new option and a proactive approach in this setting, shown to improve progression-free and overall survival in patients who haven’t progressed after standard induction treatment. This approval may lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help delay disease progression and extend survival.”
Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Genentech, emphasized the importance of this progress: “The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half. We are proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals, as it reflects our ongoing commitment to improving outcomes in the hardest-to-treat cancers.”
The IMforte Study: A Landmark Phase III Trial
The FDA approval was supported by findings from the Phase III IMforte trial, which evaluated the combination of Tecentriq and lurbinectedin as maintenance therapy versus Tecentriq alone in patients with ES-SCLC whose disease had not progressed after induction with Tecentriq, carboplatin, and etoposide.
The results were compelling:
- The combination reduced the risk of disease progression or death by 46% compared to Tecentriq alone (hazard ratio [HR]=0.54; 95% CI: 0.43–0.67; p<0.0001).
- It also reduced the risk of death by 27% (HR=0.73; 95% CI: 0.57–0.95; p=0.0174).
- The median overall survival (OS) was 13.2 months for the combination versus 10.6 months for Tecentriq alone.
- The median progression-free survival (PFS), as assessed independently, was 5.4 months versus 2.1 months, respectively.
These outcomes demonstrate a clinically meaningful improvement in both survival and disease control, offering renewed hope for patients living with this aggressive cancer.
Importantly, the safety profile of the Tecentriq-lurbinectedin combination was consistent with the known safety profiles of each drug. The most commonly observed adverse events included fatigue, nausea, neutropenia, and anemia, which were manageable with standard supportive care.
Building on Tecentriq’s Legacy in Lung Cancer
Today’s approval extends Tecentriq’s established role in the management of ES-SCLC. In 2019, Tecentriq became the first new treatment in more than two decades for this patient population when the FDA approved it in combination with chemotherapy (carboplatin and etoposide) for first-line treatment, based on the IMpower133 study.
That trial demonstrated that Tecentriq, an immune checkpoint inhibitor targeting PD-L1, could meaningfully extend overall survival compared with chemotherapy alone. Since then, Tecentriq has become a foundational therapy in the ES-SCLC treatment landscape.
The new approval now advances Tecentriq’s role beyond induction to maintenance therapy, ensuring that patients who initially benefit from Tecentriq-based induction can continue to derive benefit through prolonged disease control. The addition of lurbinectedin — a selective oncogenic transcription inhibitor that targets cancer cell replication and DNA repair mechanisms — enhances the antitumor activity of Tecentriq, providing a synergistic effect.
Broader Implications and Industry Collaboration
The approval also highlights the growing role of collaboration in oncology innovation. Genentech’s partnership with Jazz Pharmaceuticals, which markets lurbinectedin under the trade name Zepzelca®, exemplifies how combining expertise can accelerate the development of therapies for complex diseases.
Together, the two companies have advanced a treatment that not only extends survival but also demonstrates how combination approaches integrating immunotherapy and targeted cytotoxic agents can redefine care for aggressive cancers like ES-SCLC.
Commitment to Patients and Future Research
Genentech continues to invest in advancing immunotherapy-based strategies for lung cancer. Ongoing studies are exploring Tecentriq in earlier stages of disease, in combination with novel agents, and across diverse cancer types. The company remains focused on developing therapies that extend survival, improve quality of life, and personalize care for each patient’s disease biology.
“Our goal is to push the boundaries of what’s possible in cancer care,” said Garraway. “This approval reinforces that commitment and brings us closer to a future where even the most aggressive cancers can be managed more effectively and with longer-lasting control.”
About Tecentriq and Lurbinectedin
Tecentriq (atezolizumab) is a monoclonal antibody designed to bind to PD-L1, blocking its interactions with PD-1 and B7.1 receptors, thereby enabling the immune system to detect and attack cancer cells more effectively.
Lurbinectedin (Zepzelca) is an inhibitor of oncogenic transcription that binds to the DNA minor groove, affecting transcriptional activity and inducing apoptosis in cancer cells. It was initially approved for relapsed SCLC in 2020 and has since become a cornerstone agent in small cell lung cancer research.
Looking Ahead
The FDA’s approval of Tecentriq plus lurbinectedin marks an important milestone in lung cancer treatment, reinforcing the value of innovation built upon proven science. For patients with ES-SCLC — a disease notorious for relapse and resistance — this combination offers new hope for longer survival and better disease management.
As Genentech and Jazz Pharmaceuticals continue to advance their research collaborations, the oncology community moves one step closer to transforming ES-SCLC from a disease with few options to one with a growing range of effective, evidence-based therapies.
About the IMforte study
IMforte [NCT05091567] is a Phase III, open-label, randomized trial evaluating the efficacy and safety of Tecentriq® (atezolizumab) plus lurbinectedin (Zepzelca®) 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-assessed progression-free survival and overall survival from randomization into the maintenance phase.
The trial is sponsored by Genentech and co-funded by Jazz Pharmaceuticals.
About Tecentriq® (atezolizumab)
Tecentriq (atezolizumab) 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.
