IMforte (NCT05091567) is the Phase 3 trial of lurbinectedin (Zepzelca, Jazz Pharmaceuticals) plus atezolizumab (Tecentriq, Genentech/Roche) versus atezolizumab alone as first-line maintenance in extensive-stage small cell lung cancer. Primary results (ASCO 2025/Lancet): PFS 5.4 vs 2.1 months (HR 0.54) and OS 13.2 vs 10.6 months (HR 0.73) — the first Phase 3 PFS + OS win in 1L maintenance ES-SCLC, FDA-approved October 2, 2025.
See the KOL ReactionPhase 3, randomized, multicenter, open-label: induction with atezolizumab + carboplatin + etoposide (four 21-day cycles, 660 patients); 483 without progression randomized 1:1 to maintenance lurbinectedin + atezolizumab (n=242) vs atezolizumab (n=241), until progression or unacceptable toxicity. Co-primary endpoints: IRF-assessed PFS and OS, measured from maintenance randomization. Roche PR · ClinicalTrials.gov
Median PFS by independent review: 5.4 vs 2.1 months (stratified HR 0.54, 95% CI 0.43–0.67, p<0.0001); 12-month PFS 20.5% vs 12.0%. (ASCO 2025 Abstract 8006 / Lancet) OncLive (primary data) · Lancet
Median OS: 13.2 vs 10.6 months from maintenance randomization (stratified HR 0.73, 95% CI 0.57–0.95, p=0.0174) — a 27% reduction in risk of death. (ASCO 2025 Abstract 8006 / Lancet) Roche PR · Lancet
✅ FDA approved October 2, 2025: lurbinectedin + atezolizumab (or atezolizumab-hyaluronidase) as first-line maintenance for ES-SCLC without progression after atezolizumab + carboplatin + etoposide induction. Roche: FDA approval, Oct 3, 2025
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𝕏< 2 wks to #ASCO25, here is a📝 of 🔑abstracts for general onc that could guide our SoC! - #ATOMIC - #MATTERHORN - #SERENA6 - #ASCENT04 - #DestinyBreast09 - #IMforte & #Dellphi304 - Updates: #CM816 & #NIAGARA - #NIVOPOSTOP - #VERIFY #OncTwitter @ASCO @OncoAlert https://t.co/s6EWz5I8i9
𝕏IO + Lurbinectedin as maintenance is now @US_FDA approved after 4 cycles of Chemo + IO for ES-SCLC based off #IMForte study: - mOS 13.2 vs 10.6mos (HR: 0.73) - mPFS 5.4 vs 2.1mos (HR: 0.54) - Higher Gr3/4 AEs with Lurbi + Atezo #OncTwitter #MedTwitter #lcsm https://t.co/YyQXL8rIxf
𝕏#IMforte phase 3 study in ES-SCLC— Maintenance lurbinectedin + atezolizumab v atezolizumab ▫️PFS: 5.4 v 2.1 mo (HR 0.54) ▫️OS: 13.2 v 10.6 mo (HR 0.73) ▫️Grade 3/4 AEs: 25.6% v 5.8% ▫️Tx discontinuation 2/2 AEs: 6.2% v 3.3% Practice-changing? @OncoAlert @SclcSMASHERS #ASCO25 https://t.co/NcvJjXNpdM https://t.co/WmBp3dlYwb
𝕏💡 After 2 oral presentations that definitively change the treatment landscape and impacts in survival for patients with ES-SCLC (any of them, if not both, should have been plenary @ASCO this year), the key question here is: when will we have access to lurbinectedin and https://t.co/IZR56E8nw8
𝕏Roche's Tecentriq cancer drug with Jazz Pharmaceuticals’s lurbinectedin has been cleared to treat patients with extensive-stage small cell lung cancer https://t.co/gasJqJGf25
𝕏🔥🚨@OncoAlert Hot Off The Press Just presented @ASCO #ASCO25 by the amazing @LuisPaz_Ares ✅Results of #IMforte trial of: #Lurbinectedin + #Atezolizumab as 1st line #Maintenance Tx in #Patients with #ExtensiveStage #SmallCell #LungCancer. 👇🏻 https://t.co/UQqAy3LsDv
𝕏🚨@JazzPharma announces positive results from the phase 3 IMforte study with combination lurbinectedin + atezolizumab in first-line maintenance therapy for ES-SCLC ✅ Statistically significant improvements in OS and PFS vs atezolizumab alone @SclcSMASHERS @OncoAlert #lcsm https://t.co/1uGWhF2Psw
𝕏Results from phase I/II LUPER study of lurbinectedin + pembrolizumab in #SCLC @JTOonline. RR 46.4% including 3 CR with DOR 7.8m, PFS 4.6m, OS 10.5m. In platinum sensitive, PFS 8m, OS 15.7m. Combination data relevant in light of forthcoming IMforte data. https://t.co/1WPfyBvqd0
𝕏Updates to NCCN SCLC guidelines includes the option of maintenance lurbinectedin 3.2mg/m2 (with primary G-CSF) plus atezolizumab after induction (for patients who have not progressed). Based on phase III IMforte study that showed improvement in PFS (HR 0.54) and OS (HR 0.73). https://t.co/uC5Pu4mTPi
𝕏🇺🇸 In the US, both lurbinectedin and tarlatamab are now available to treat patients with #SCLC. Each agent has demonstrated to improve overall survival. 🇪🇺Meanwhile in Europe, we treat patients with topotecan. A drug from last century that barely improves survival in few weeks https://t.co/p69vV8fyfN
Phase 3, randomized (1:1), multicenter, open-label; 660 enrolled in induction, 483 randomized to maintenance (242 combination / 241 atezolizumab).
Adults with ES-SCLC, no prior systemic SCLC therapy, ECOG PS 0–1, without progression after induction atezolizumab + carboplatin + etoposide (4 × 21-day cycles).
Maintenance lurbinectedin + atezolizumab vs atezolizumab alone, until progression or unacceptable toxicity. No crossover to lurbinectedin was allowed — a design point KOLs debated.
Co-primary: IRF-assessed PFS and OS from maintenance randomization (RECIST 1.1). Secondary: response, safety, PROs.
Lurbinectedin is a selective inhibitor of oncogenic transcription; atezolizumab maintains PD-L1 checkpoint blockade from induction.
Genentech (Roche), in collaboration with Jazz Pharmaceuticals (lurbinectedin).
PFS by independent review: median 5.4 vs 2.1 months (stratified HR 0.54, 95% CI 0.43–0.67, p<0.0001); 12-month PFS 20.5% vs 12.0%. OS: median 13.2 vs 10.6 months (stratified HR 0.73, 95% CI 0.57–0.95, p=0.0174). Both endpoints measured from maintenance randomization — time on induction is not included, a distinction KOLs on this page emphasized. (ASCO 2025 Abstract 8006 / Lancet 2025;405:2129-43)
First Phase 3 PFS + OS improvement in 1L maintenance ES-SCLCSafety was generally consistent with the known profiles of atezolizumab and lurbinectedin (Roche PR). Adverse-event rates were higher with the combination — the ASCO deck’s AE table (slide above, with full OCR) shows all-cause AE rates by arm — with nausea, anemia and fatigue among the most common; physicians discussed proactive management including prophylactic growth factors on the OncBrothers episode.
Source: Roche media release, Oct 3, 2025✅ FDA-approved standard-of-care option for 1L maintenance in ES-SCLC after atezolizumab-based induction. KOL discussion on this page carries both the enthusiasm (“first Phase 3 to show PFS and OS improvement with 1L maintenance” — Paz-Ares) and the critiques, verbatim: no crossover to an active 2L-approved drug, and real-world toxicity management. With DeLLphi-305’s tarlatamab + durvalumab topline (Sept 2026, investigational), the 1L maintenance window in ES-SCLC now has an approved chemotherapy-based intensification and a BiTE-based challenger behind it.
Source: Oncology Brothers episode (Preeshagul, Leal, Liu), Oct 2025IMforte (NCT05091567) is a Phase 3, randomized, multicenter, open-label trial testing lurbinectedin (Zepzelca, Jazz Pharmaceuticals) plus atezolizumab (Tecentriq, Genentech/Roche) versus atezolizumab alone as first-line maintenance therapy in extensive-stage small cell lung cancer. 660 patients entered induction with atezolizumab, carboplatin and etoposide (four 21-day cycles); 483 without progression were randomized 1:1 to maintenance (242 combination, 241 atezolizumab). Co-primary endpoints: independent-review PFS and OS, measured from maintenance randomization.
Per the primary analysis (ASCO 2025 Abstract 8006; Lancet 2025;405:2129-43), median PFS by independent review was 5.4 months with lurbinectedin plus atezolizumab versus 2.1 months with atezolizumab alone (HR 0.54, 95% CI 0.43-0.67, p<0.0001; 12-month PFS 20.5% vs 12.0%), and median OS was 13.2 versus 10.6 months (HR 0.73, 95% CI 0.57-0.95, p=0.0174). IMforte was the first Phase 3 trial to show both PFS and OS improvement with first-line maintenance treatment in ES-SCLC.
Yes. On October 2, 2025 the FDA approved lurbinectedin in combination with atezolizumab (or atezolizumab and hyaluronidase-tqjs) as first-line maintenance treatment for adults with ES-SCLC whose disease has not progressed after first-line induction with atezolizumab, carboplatin and etoposide.
Per Roche's approval announcement, safety was generally consistent with the known profiles of atezolizumab and lurbinectedin. Adverse event rates were higher in the combination arm than with atezolizumab alone - nausea, anemia and fatigue were among the most common - and physicians on this page discussed proactive management, including prophylactic growth factors. Two design critiques also appear verbatim in the KOL discussion: no crossover to lurbinectedin was allowed, and toxicity carries a learning curve with newer agents.
Both trials target the same first-line maintenance window in ES-SCLC. IMforte established the first FDA-approved maintenance intensification (chemotherapy-based, October 2025). DeLLphi-305 - tarlatamab plus durvalumab, topline September 8, 2026 - is the first Phase 3 bispecific T-cell engager to show an OS benefit in that setting and remains investigational. Cross-trial comparisons are hypothesis-generating only; the trials used different induction backbones and control arms.