FDA Approves Tecentriq Plus Lurbinectedin as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
In a landmark decision for the lung cancer community, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved a new treatment combination that promises to change the care landscape for people with extensive-stage small cell lung cancer (ES-SCLC).
The FDA granted approval to Tecentriq® (atezolizumab) and its subcutaneous formulation Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) as a first-line maintenance therapy for adult patients with ES-SCLC whose disease has not progressed after initial induction treatment. This induction regimen typically includes Tecentriq or Tecentriq Hybreza with the standard chemotherapy agents carboplatin and etoposide (CE).
This milestone marks the first and only FDA-approved combination therapy for first-line maintenance in ES-SCLC, providing new hope for patients with one of the most aggressive and difficult-to-treat cancers.
Why the Approval Matters
Small cell lung cancer (SCLC) is a fast-growing and highly lethal form of lung cancer, representing approximately 10–15% of all lung cancer diagnoses. Within this subset, extensive-stage disease accounts for the majority of cases at the time of diagnosis. Patients often present with advanced tumors that have already spread beyond the lungs to other parts of the body, limiting curative options.
The prognosis for ES-SCLC remains poor. Most patients initially respond to chemotherapy combined with immunotherapy, but the risk of relapse is extremely high, and survival rates remain dismally low. Median overall survival has traditionally been around 10 to 12 months, with fewer than 7% of patients surviving five years after diagnosis.
Against this backdrop, the FDA’s decision introduces a critical new treatment strategy: maintaining disease control with the combination of Tecentriq plus lurbinectedin after induction therapy has stabilized the disease. The goal is to delay disease progression, extend survival, and give patients more quality time.
Clinical Data Driving Approval
The FDA’s approval was supported by findings from the Phase III IMforte trial, a randomized study evaluating the effectiveness of Tecentriq plus lurbinectedin versus Tecentriq alone as maintenance therapy in ES-SCLC.
Key results from the IMforte study include:
- Progression-Free Survival (PFS):
The combination reduced the risk of disease progression or death by 46% compared to Tecentriq alone. Median PFS improved to 5.4 months versus 2.1 months with Tecentriq monotherapy (HR=0.54; 95% CI: 0.43–0.67; p<0.0001). - Overall Survival (OS):
Patients receiving the combination therapy lived a median of 13.2 months, compared to 10.6 months for those on Tecentriq alone (HR=0.73; 95% CI: 0.57–0.95; p=0.0174). This reflects a 27% reduction in the risk of death. - Safety Profile:
Side effects were generally consistent with what has previously been observed for Tecentriq and lurbinectedin individually. No unexpected safety signals were reported.
The magnitude of benefit in both PFS and OS was significant enough to influence guidelines rapidly. The U.S. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology have already been updated to include the Tecentriq plus lurbinectedin regimen as a category 2A and preferred option for maintenance treatment of ES-SCLC following induction with Tecentriq and chemotherapy.
Expert Perspectives
Oncologists view this approval as a critical step forward in addressing the urgent unmet need for better maintenance strategies in ES-SCLC.
Dr. Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and hematology at Yale Cancer Center and Smilow Cancer Hospital, emphasized the importance of having proactive treatment options for patients after first-line induction therapy:
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. 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. The 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.
Dr. Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Roche, also highlighted the transformative potential of the therapy:
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 abiding commitment to improving outcomes in the hardest-to-treat cancers.
Building on Tecentriq’s Role in SCLC
This approval builds upon Tecentriq’s established presence in SCLC treatment. In 2019, Tecentriq became the first new therapy in two decades to be approved for ES-SCLC, in combination with carboplatin and etoposide as first-line treatment. That approval was based on the pivotal IMpower133 trial, which demonstrated significant improvements in both overall survival and progression-free survival compared to chemotherapy alone.
The new combination with lurbinectedin extends Tecentriq’s role beyond induction to long-term maintenance therapy, creating a continuum of care strategy. By adding lurbinectedin—a drug with a unique mechanism of action as a selective inhibitor of oncogenic transcription programs—the regimen appears to enhance and prolong the anti-tumor activity of immunotherapy.
Partnership with Jazz Pharmaceuticals
The approval was made possible through collaboration between Genentech and Jazz Pharmaceuticals, the developer of lurbinectedin. Zepzelca (lurbinectedin) was first granted accelerated approval by the FDA in 2020 as a second-line therapy for patients with metastatic SCLC who had progressed on or after platinum-based chemotherapy.
Its integration into the first-line maintenance setting with Tecentriq marks an important expansion of its use. Jazz and Genentech’s partnership demonstrates how biopharma collaborations can accelerate innovation and deliver new treatment standards in oncology.
Implications for Patients and the Cancer Community
For patients living with ES-SCLC, the approval represents a meaningful step forward. After completing initial chemotherapy and immunotherapy, patients often face a period of uncertainty where treatment options are scarce and the risk of relapse looms large. Having a validated maintenance therapy that significantly extends both progression-free and overall survival offers patients and their families renewed hope.
For clinicians, the decision provides clear guidance on how to manage patients after induction therapy. The rapid inclusion of the Tecentriq plus lurbinectedin regimen in the NCCN guidelines ensures that oncologists across the U.S. can begin implementing the new standard of care quickly.
For the wider oncology community, the approval underscores the importance of clinical trial participation. The results of IMforte not only validated a new treatment strategy but also demonstrated how continued innovation in trial design and drug development can lead to real-world improvements in survival for difficult-to-treat cancers.
