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KOL Pulse · AI-Native Trial Intelligence

IMforte Trial

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.

Phase 3 · NCT05091567 ES-SCLC · 1L maintenance OS 13.2 vs 10.6 mo · HR 0.73 (ASCO 8006) ✅ FDA approved · Oct 2, 2025
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IMforte Key Takeaways

Design

Phase 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

PFS

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

OS

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

Regulatory

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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Top KOLs Discussing IMforte

Luis Paz-Ares, MD PhD
Luis Paz-Ares, MD PhD
Presenter · H. 12 de Octubre
Oncology Brothers
Oncology Brothers
81.8K impressions
Stephen V Liu, MD
Stephen V Liu, MD
50.3K impressions
Eric K. Singhi, MD
Eric K. Singhi, MD
44.4K impressions
Dr. Antonio Calles 🫁🚭
Dr. Antonio Calles
42.8K impressions
Rami Manochakian MD, FASCO Cancer Education
Rami Manochakian MD, FASCO Cancer Education
25.1K impressions
Hidehito HORINOUCHI
Hidehito HORINOUCHI
14.5K impressions
Aakash Desai, MD, MPH, FASCO
Aakash Desai, MD, MPH, FASCO
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gilberto lopes
gilberto lopes
13.8K impressions
Dr Amol Akhade
Dr Amol Akhade
11.6K impressions
Chul Kim
Chul Kim
6.8K impressions
Nathan A. Pennell MD, PhD, FASCO
Nathan A. Pennell MD, PhD, FASCO
6.6K impressions
Misty Dawn Shields
Misty Dawn Shields
6.3K impressions

IMforte Key Slides & Visuals

ASCO 2025 deck photos from Dr. Paz-Ares’ oral presentation (Abstract 8006), the live room, and later cross-trial context. Full transcripts via the OCR toggle on each card. All numbers on these slides are from the ASCO 2025 primary analysis.

Rami Manochakian MD, FASCO Cancer Education @RManochakian · 2025-06-02
ASCO25 primary results deck — PFS from maintenance randomization
Presented by Dr. Luis Paz-Ares, ASCO 2025 (Abstract 8006)
View Post
IMforte — ASCO25 primary results deck — PFS from maintenance randomization (1)IMforte — ASCO25 primary results deck — PFS from maintenance randomization (2)IMforte — ASCO25 primary results deck — PFS from maintenance randomization (3)IMforte — ASCO25 primary results deck — PFS from maintenance randomization (4)
[Slide 1] 8 IRF-PFS from randomization into maintenance phase R PFS assessment started from randomization into the maintenance phase 100 Lurbi + atezo Atezo IRF-PFS (n=242) (n=241) Events, n (%) 174 (71.9) 202 (83.8) 80 PFS median (95% CI). mo 5.4 (4.2.5.8) 2.1 (1.6.2.7) 6-mo IRF-PFS 12-mo IRF-PFS Stratified HR (95% CI) 0.54 (0.43, 0.67) Stratified Pvalue (2-sided) <0.0001 60 a boundary (2-sided) 0.001 41.2% 40 18.7% 20.5% 20 12.0% 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Time from randomization (months) No. at risk Lurbi atezo 242 231 184 152 138 103 76 62 57 43 35 33 24 20 16 14 11 10 4 2 1 1 0 0 Atezo 241 224 123 79 69 50 34 27 27 24 18 16 13 13 12 12 7 6 5 3 3 2 2 Clinical cutoff July 29, 2024; median survival follow-up 15.0 mo (minimum follow-up: 3.0 mo). CI, confidence interval; HR, hazard ratio 2025 ASCO PRESENTED BY Luis Paz-Ares. MD. PhD IMforte ASCO 2025 #ASCO25 ASCO AMERICAN SOCIETY OF CUNICAL ONCOLOGY ANNUAL MEETING Presentation . property of the author and ASCO Abstract 8006 KNOWLEDGE CONQUERS CANCER --- [Slide 2] 18 Conclusions IMforte demonstrated a statistically significant and clinically meaningful improvement in IRF-PFS and os with 1L maintenance treatment with lurbinectedin + atezolizumab vs atezolizumab in patients with ES-SCLC - Stratified IRF-PFS HR: 0.54 (95% CI: 0.43, 0.67); P<0.0001 - Stratified os HR: 0.73 (95% CI: 0.57, 0.95); P=0.0174 IRF-PFS and os benefit with lurbinectedin + atezolizumab was generally consistent across the majority of subgroups Despite the higher rate of Grade 3/4 AEs and SAEs, there were no new or unexpected safety signals with lurbinectedin + atezolizumab - The safety profile was predictable, with mostly low-grade AEs and low treatment discontinuation rates - There was no clinically meaningful increase in immune-related AEs IMforte is the first Phase 3 study to show PFS and os improvement with 1L maintenance treatment for ES-SCLC, highlighting the potential of lurbinectedin + atezolizumab to become a new standard of care for 1L maintenance therapy in patients with this aggressive and difficult-to-treat disease 2025 ASCO #ASCO25 PRE SENTED Luis Paz-Ares MD. PhD IMforte ASCO 2025 ASCO AMARANC AN SOCIETY OF CLINICAL ONCOLOGY 2006
Dr Amol Akhade @SuyogCancer · 2025-06-03
OS subgroup analysis
ASCO 2025 deck (Abstract 8006)
View Post
IMforte — OS subgroup analysis (1)IMforte — OS subgroup analysis (2)IMforte — OS subgroup analysis (3)IMforte — OS subgroup analysis (4)
[Slide 1] 13 os subgroup analysis Events/patients, n/N Favors lurbi + atezo Favors atezo Unstratified Baseline risk factors Lurbi + atezo Atezo os HR (95% CI) All patients 113/242 136/241 0.74 (0.58,0 0.96) Age, years <65 53/118 49/90 0.77 (0.52, 1.14) >65 60/124 87/151 0.76 (0.55,1.05) Sex Male 75/151 88/151 0.72 (0.53, 0.98) Female 38/91 48/90 0.78 (0.51,1.19) Race White 92/195 118/199 0.71 (0.54,0.94) Asian 13/31 14/31 0.86 (0.40, 1.84) Tobacco use history" Current 38/88 39/73 0.79 (0.51, 1.24) Previous 72/147 94/163 0.76 (0.56, 1.03) Liver metastases at Yes 55/100 63/94 0.70 (0.48,1.00) Induction BLb No 58/142 73/147 0.76 (0.54,1.07) Prior PCI Yes 16/34 18/37 1.02 (0.52,2.00) No 97/208 118/204 0.70 (0.53,0.9) ECOG PSb 0 51/105 53/102 0.88 (0.60,1.29) 1 62/137 83/139 0.66 (0.47.0.9 LDH SULN 72/176 97/179 0.66 (0.49,0.90) >ULN 41/66 39/62 0.96 (0.62,1.50) Response to CR/PR 92/206 115/213 0.76 (0.57,0.99) induction therapy20 SD 17/28 18/25 0.62 (0.31,1.24) 0.1 1 4 Clinical cutoff: July 29, 2024; median survival follow-up: 15.0 mo (minimum follow-up: 3.0 mo). a Data from subgroups with small numbers are not displayed. b Stratification factor for randomization; data determined from electronic case-report forms. n=236 in the lurbi + atezo arm and n=240 in the atezo arm; 7 randomized patients did not have a maintenance screening tumor assessment 2025 ASCO PRESENTED BY: Luis Paz-Ares, MD, PhD IMforte ASCO 2025 ASCO AMERICAN SOCIETY OF #ASCO25 CLINICAL ONCOLOGY ANNUAL MEETING Abstract 8006 KNOWLEDGE CONQUERS CANCER
Shankar Siva @_ShankarSiva · 2025-06-02
All-cause adverse events by arm
ASCO 2025 deck (Abstract 8006)
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IMforte — All-cause adverse events by arm (1)IMforte — All-cause adverse events by arm (2)IMforte — All-cause adverse events by arm (3)IMforte — All-cause adverse events by arm (4)
[Slide 1] 17 All-cause AEs with incidence 10% in either arm Lurbi + atezo Atezo Any AE 97.1% 80.8% Nausea 36.4% 4.2% Anemia 31.8% 6.7% Fatigue 20.2% 7.9% Decreased appetite 16.9% 6.7% Platelet count decreased 15.3% 2.9% Febrile neutropenia Lurbi + atezo: 1.7% Diarrhea 14.0% 7.5% Atezo: 0% Vomiting 13.6% 2.5% Grade 3/4 infections and infestations Asthenia 12.8% 6.3% Lurbi + atezo: 6.6% Thrombocytopenia 12.8% 1.7% Atezo: 5.0% Neutrophil count decreased 12.8% 1.3% Grade 1/2 Grade 3/4 Constipation 12.0% 6.3% Neutropenia 10.7% 1.7% 100% 80% 60% 20% 0% 20% 40% 60% 80% 100% Patients (%) Clinical cutoff: July 29, 2024. Percentage labels represent all-grade AEs, including Grade 5 AEs. Grade 5 AEs occurred in 12 (5.0%) patients in the lurbi + atezo arm and 6 (2.5%) patients in the atezo arm. a Includes 1 Grade 5 AE. b Grade 5 infections: lurbi + atezo arm (n=6 [2.5%]): COVID-19 pneumonia, pneumonia, pneumonia viral, sepsis, septic shock, and vascular device infection (n=1 each): atezo arm (n=4 [1.7%]): pneumonia (n=2), abscess intestinal, and sepsis (n=1 each). ASCO PRESENTED BY: Luis Paz-Ares, MD, PhD IMforte ASCO 2025 ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY 2025 #ASCO25 Abstract 8006 ANNUAL MEETING is property of the author and ASCO Permission required for contact KNOWLEDGE CONQUERS CANCER
Stephen V Liu, MD @StephenVLiu · 2025-06-02
Dr. Paz-Ares presenting at ASCO25 — photographed live
In-room shots from Dr. Stephen Liu
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IMforte — Dr. Paz-Ares presenting at ASCO25 — photographed live (1)IMforte — Dr. Paz-Ares presenting at ASCO25 — photographed live (2)IMforte — Dr. Paz-Ares presenting at ASCO25 — photographed live (3)IMforte — Dr. Paz-Ares presenting at ASCO25 — photographed live (4)
DAVA Oncology @DAVAOnc · 2026-07-09
IMforte vs IMpower133 — cross-trial PFS context
Cross-trial comparison shared July 2026; not a randomized comparison
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IMforte — IMforte vs IMpower133 — cross-trial PFS context (1)IMforte — IMforte vs IMpower133 — cross-trial PFS context (2)IMforte — IMforte vs IMpower133 — cross-trial PFS context (3)IMforte — IMforte vs IMpower133 — cross-trial PFS context (4)
[Slide 1] IMforte vs IMpower INV-PFS (%) KM curve - IMforte vs IMpower 133; landmarks at 12 Mo and 24 Mo. Forest plot IRF-PFS (Favours lurbi + atezo vs Favours atezo), Unstratified HR (95% CI): BEP: n=412, HR 0.55 (0.44, 0.69) PD-L1 status by SP263: IC or TC >=1%: n=193, 0.66 (0.48, 0.93) IC or TC <1%: n=219, 0.43 (0.32, 0.58) IC or TC >=5%: n=57, 0.91 (0.48, 1.73) IC or TC <5%: n=356, 0.51 (0.40, 0.65) Paz-Arez, ESMO IO 2025 --- [Slide 2] TAM biomarker provides proof of principle IRF-PFS and OS by TAM/T-eff - Patients with high TAM/high T-eff in the atezolizumab arm had a numerically shorter IRF-PFS and OS (mPFS: 2.63 months and mOS: 12.25 months) versus those with low TAM/high T-eff (mPFS: 4.76 months and mOS: 16.39 months), reiterating the potential inhibitory effect of TAMs with atezolizumab treatment. - Numerical trends in IRF-PFS and OS suggest that lurbinectedin may overcome TAM-mediated resistance to atezolizumab. High TAM/high T-eff: IRF-PFS Atezo 2.63 vs Lurbi+Atezo 5.59, HR 0.64 (0.4, 1.03); OS Atezo 12.25 vs Lurbi+Atezo 22.20, HR 0.55 (0.29, 1.01). Low TAM/high T-eff: IRF-PFS Atezo 4.76 vs Lurbi+Atezo 6.97, HR 0.82 (0.4, 1.65); OS Atezo 16.39 vs Lurbi+Atezo 12.75, HR 0.95 (0.42, 2.14). Summary: TAM low OS = 16.4 mo -> TAM high = 12.3 mo -> TAM high + lurbi = 17.2 mo --- [Slide 3] Rationale for IMforte: Lurbi attacks TAMs [IHC CD68 Untreated vs Treated, quantification bar chart ***, 50 um] LURBINECTEDIN: Inhibition of cell migration; Induction of apoptosis; Reduced cancer-related inflammation. Tumour -> CCL2 -> Monocyte -> TAM; CCL2, CXCL8, VEGF. Cancer Cell 2013 23, 249-262 DOI: (10.1016/j.ccr.2013.01.008); Br J Cancer. 2017 Aug 22;117(5):628-638 --- [Slide 4] Rationale for IMforte: TAMs are bad in small cell [Myeloid differentiation schematic: Bone marrow/spleen -> Bloodstream -> Tumor site; Mo-MDSC, Monocytes, PMN-MDSC, Neutrophils, LyGC CD11b, CD16, TAMs, F4/80, MHC II, CD68; increasing requirement for resistance to apoptosis (BCL-A1), increased APO1 expression, increasing requirement for survival factors/cytokines] TAMs (CD68+) are the PD-L1 expressing cells in SCLC. [IHC panels C: PD-L1; D: CD68] Nature Communications volume 7, Article number: 12160 (2016) doi:10.1038/ncomms12160; European Journal of Cancer Volume 51, Issue 3, Pages 421-426

IMforte Top Tweets

Oncology Brothers@OncBrothers
𝕏

&lt; 2 wks to #ASCO25, here is a📝 of 🔑abstracts for general onc that could guide our SoC! - #ATOMIC - #MATTERHORN - #SERENA6 - #ASCENT04 - #DestinyBreast09 - #IMforte &amp; #Dellphi304 - Updates: #CM816 &amp; #NIAGARA - #NIVOPOSTOP - #VERIFY #OncTwitter @ASCO @OncoAlert https://t.co/s6EWz5I8i9

37.9K views 256 likes83 RT 2025-05-17
Oncology Brothers@OncBrothers
𝕏

IO + 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

29.9K views 105 likes34 RT 2025-10-02
Eric K. Singhi, MD@lungoncdoc
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

18.5K views 60 likes25 RT 2025-05-22
Dr. Antonio Calles 🫁🚭@Tony_Calles
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

18.1K views 100 likes31 RT 2025-06-02
Bloomberg@business
𝕏

Roche'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

17.6K views 32 likes8 RT 2025-10-03
Rami Manochakian MD, FASCO Cancer Education@RManochakian
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

11.9K views 29 likes20 RT 2025-06-02
Eric K. Singhi, MD@lungoncdoc
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

11.6K views 56 likes18 RT 2024-10-15
Stephen V Liu, MD@StephenVLiu
𝕏

Results 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

11.2K views 106 likes45 RT 2025-02-10
Stephen V Liu, MD@StephenVLiu
𝕏

Updates 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

11.1K views 178 likes61 RT 2025-09-17
Dr. Antonio Calles 🫁🚭@Tony_Calles
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

11.0K views 70 likes16 RT 2025-10-02

FDA Approval — October 2, 2025

FDA APPROVED Lurbinectedin + atezolizumab, 1L maintenance ES-SCLC

On October 2, 2025 the FDA approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs as first-line maintenance treatment for adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction with atezolizumab, carboplatin and etoposide — the first approved maintenance-intensification regimen in this setting, based on IMforte’s PFS and OS results.

Source: Roche media release, Oct 3, 2025

Trial Methodology & Results

Study Design

Phase 3, randomized (1:1), multicenter, open-label; 660 enrolled in induction, 483 randomized to maintenance (242 combination / 241 atezolizumab).

Population

Adults with ES-SCLC, no prior systemic SCLC therapy, ECOG PS 0–1, without progression after induction atezolizumab + carboplatin + etoposide (4 × 21-day cycles).

Interventions

Maintenance lurbinectedin + atezolizumab vs atezolizumab alone, until progression or unacceptable toxicity. No crossover to lurbinectedin was allowed — a design point KOLs debated.

Endpoints

Co-primary: IRF-assessed PFS and OS from maintenance randomization (RECIST 1.1). Secondary: response, safety, PROs.

Mechanism

Lurbinectedin is a selective inhibitor of oncogenic transcription; atezolizumab maintains PD-L1 checkpoint blockade from induction.

Sponsors

Genentech (Roche), in collaboration with Jazz Pharmaceuticals (lurbinectedin).

Efficacy

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-SCLC
Source: Lancet, June 2025

Safety

Safety 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

Clinical Implications

✅ 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 2025

IMforte in the News

IMforte FAQ

What is the IMforte trial?

IMforte (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.

What did the IMforte results show?

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.

Is lurbinectedin plus atezolizumab FDA approved?

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.

What about the safety of the combination?

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.

How does IMforte relate to DeLLphi-305?

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.

Key KOL Sentiments — IMforte

KOLComment (verbatim)Sentiment
Stephen V Liu, MD Dr. @LuisPaz_Ares at #ASCO25 with phase III IMforte trial. Adding maintenance lurbinectidin to first-line maintenance atezolizumab in ES #SCLC improves both PFS &amp; OS, meeting primary endpoints. PFS HR 0.54 and OS HR 0.73 with use of lurbinectedin. Value in avoiding attrition. https://t.co/UmYIaiJ5iE Positive
Misty Dawn Shields 📣Hot off the press: IMforte presented by Dr. Luis Paz-Ares at #ASCO25 Addition of lurbinectedin to atezolizumab in maintenance for 1L ES-SCLC improves: ⭐️PFS (HR 0.54, 5.4 vs 2.1m) ⭐️mOS from maint randomization (HR 0.73, 13.2 vs 10.6m) ⚠️ Heme tox (FN 1.7%) ➡️New SOC for 1L https://t.co/V2QE2mzmMI Positive
Stephen V Liu, MD Proud to be part of the IMforte effort - the first phase 3 maintenance study in #SCLC to show a survival benefit with an OS HR 0.73 - grateful to the team @LuisPaz_Ares @HosseinBorghaei @peters_solange @DrRoyHerbstYale @MLJohnsonMD2 @caliraf @MartinReck2 https://t.co/iJj1WkpqFm Positive
Ana I. Velázquez Mañana, MD, MSc, FASCO Practice changing results from the IMforte trial presented at #ASCO25 &amp; published @TheLancet today! 🔑 Maintenance lurbinectedin + atezolizumab is the new SOC in first line ES-SCLC #LCSM https://t.co/lBxXid4fdV https://t.co/WEze02Auwy Positive
Dr. Antonio Calles 🫁🚭 Happy to see that earlier evidence on the safety and efficacy of combining lurbinectedin with immunotherapy (2SMALL- atezolizumab; LUPER- pembrolizumab) ultimately helped to improve survival in patients with Small-cell #lungcancer based on the IMforte trial. @SclcSMASHERS #LCSM https://t.co/TwruOX8OD0 Positive
Sanjay Popat This is a superb result for #SCLC. Look forward to the data in due course. Boy do we need some additional options for our SCLC patients. Have to say the SCLC drug development space is very interesting, indeed, with lurbi, ADCs and T-cell engagers @BTOGORG https://t.co/jw97QlnlSG Positive
Isabel Preeshagul Thrilled to have another approval in this space with OS AND PFS data . Things to think about : 🤔 - cytopenias and gCSF support - dose reduction - CNS efficacy @SclcSMASHERS @drshieldsmd https://t.co/WjZpDrAp1T Positive
Balazs Halmos IMForte trial of atezo+- lurbinectidine for pts w ES-SCLC (note no CNS disease) Expected PFS and (as pleasant surprise) quite notable OS benefit linked w fair toxicity/ easy implementation makes me believe that this regimen will immediately Jazz up the ES-SCLC landscape as the https://t.co/VE65Oydfvm Positive
Dr Amol Akhade 📢 #IMforte @ASCO2025 New hope in ES-SCLC maintenance! 🫁✨ Lurbinectedin + Atezolizumab outperforms Atezo alone 💪 🧪 PFS: 5.4 vs 2.1 months HR 0.54 (0.43–0.67) 🔥 12-mo PFS: 20.5% vs 12.0% 💀 OS: 13.2 vs 10.6 months HR 0.73 (0.57–0.95) 12-mo OS: 56.3% vs 44.1% ✅ Consistent https://t.co/08rMJ7GHQ2 Positive
Oncology Brothers &lt; 2 wks to #ASCO25, here is a📝 of 🔑abstracts for general onc that could guide our SoC! - #ATOMIC - #MATTERHORN - #SERENA6 - #ASCENT04 - #DestinyBreast09 - #IMforte &amp; #Dellphi304 - Updates: #CM816 &amp; #NIAGARA - #NIVOPOSTOP - #VERIFY #OncTwitter @ASCO @OncoAlert https://t.co/s6EWz5I8i9 Neutral
Oncology Brothers IO + 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 Neutral
Eric K. Singhi, MD #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 Neutral
Dr. Antonio Calles 🫁🚭 💡 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 Neutral
Rami Manochakian MD, FASCO Cancer Education 🔥🚨@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 Neutral
Eric K. Singhi, MD 🚨@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 Neutral
Stephen V Liu, MD Results 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 Neutral
Stephen V Liu, MD Updates 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 Neutral
Dr. Antonio Calles 🫁🚭 🇺🇸 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 Neutral
Oncology Brothers Day 4 #ASCO25 Highlights: 1. #DestinyBreast09: 1L TDXd Her2+ MBC 2. #SOFT/TEXT: Adj endo breast ca 3. #CM816: NeoAdj Nivo/chemo NSCLC 4. #NeoADAURA: NeoAdj Osi mEGFR NSCLC 5. #DeLLphi304: 2L Tarla SCLC 6. #IMForte: 1L maint Lurbi ES-SCLC 7. Timings for IO @ASCO 1/8 https://t.co/QLrVYEExIs Neutral
Dr. Antonio Calles 🫁🚭 👉 Two practice changing trials that will shape a new era in the treatment of patients with SCLC #ASCO25 #LCSM @SclcSMASHERS https://t.co/IqCfQxXpbT Neutral
Patrick Forde Is the juice worth the squeeze? Suspect this may be a near term move up the treatment schedule until first line &amp; maintenance DLL3 T cell engager trials read out. Also is a confirmatory trial for lurbinectedin which had not shown an OS benefit second line. #lcsm https://t.co/6JGludmpGY Negative
gilberto lopes Important to understand that toxicity, there is always a learning curve with "new" agents. Real concern to make sure patients get further lines of treatment in this hard to manage disease. The main reason patients don't get further lines however is quick disease progression https://t.co/4yf0SyrBjT Negative
Nathan A. Pennell MD, PhD, FASCO Look forward to slides. No crossover allowed which is odd since lurbi is approved 2nd line, would like to see subsequent tx in control arm. PFS not surprising , but for OS is it just everyone gets early 2nd line treatment vs fewer ppl getting 2nd line treatment? #ASCO25 https://t.co/uLqj1nHGCD Negative
Veli Bakalov, MD @ADesaiMD Are we ok with control arm not getting lurbi in pre tarla era? Not allowing crossover for biologically active drug 🤷🏼‍♂️ what? Negative