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DeLLphi-305 Trial

DeLLphi-305 (NCT06211036) is the global Phase 3 trial of tarlatamab (IMDELLTRA, Amgen) plus durvalumab (Imfinzi, AstraZeneca) versus durvalumab alone as first-line maintenance in extensive-stage small cell lung cancer. Topline results (Sept 8, 2026): overall survival significantly improved at a pre-specified interim analysis — the first Phase 3 BiTE therapy to extend survival in 1L maintenance ES-SCLC. The 1L combination is investigational; tarlatamab is FDA-approved in the second-line setting.

Phase 3 · NCT06211036 ES-SCLC · 1L maintenance Topline: OS met at interim (Sept 8, 2026) ⚠ 1L combination investigational ✅ Tarlatamab FDA-approved 2L+ (full, Nov 2025)
See the KOL Reaction

DeLLphi-305 Key Takeaways

Design

Global, randomized (1:1), open-label Phase 3: tarlatamab IV every 2 weeks + durvalumab IV every 4 weeks vs durvalumab IV every 4 weeks alone, as first-line maintenance in adults with ES-SCLC who completed platinum/etoposide with concurrent durvalumab without progression (no symptomatic CNS metastases; ECOG PS 0–1). 563 patients randomized. Primary endpoint: overall survival; secondary: PFS, ORR, DCR, DoR, TTP, safety, QoL. Amgen PR · OncoDaily (563 randomized) · ClinicalTrials.gov

Topline result — Sept 8, 2026

Primary endpoint met at a pre-specified interim analysis: statistically significant and clinically meaningful improvement in overall survival vs durvalumab alone, with significant improvements also in PFS and ORR (key secondary endpoints). No hazard ratios or medians disclosed yet — detailed data at an upcoming medical congress. First Phase 3 study of a bispecific T-cell engager to show an OS benefit in 1L maintenance ES-SCLC. Source: Amgen press release, Sept 8, 2026

Safety

Safety profile consistent with the known profiles of the individual medicines; no new or unexpected safety signals. Monitoring after tarlatamab infusion: 1–2 hours (6–8 hours in certain regions including Europe) on Cycle 1 Day 1 and Day 8. Source: Amgen press release, Sept 8, 2026

Regulatory

⚠ The 1L maintenance combination is investigational — not FDA-approved for this setting. ✅ Tarlatamab (IMDELLTRA) holds full FDA approval (Nov 19, 2025, converted from May 2024 accelerated approval on DeLLphi-304 confirmatory data: OS 13.6 vs 8.3 months, HR 0.60) for ES-SCLC progressing on or after platinum-based chemotherapy, and is NCCN Category 1 preferred in that setting. Amgen: full approval (Nov 2025) · Targeted Oncology (DeLLphi-304 numbers)

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Top KOLs Discussing DeLLphi-305

Jacob Sands, MD
Jacob Sands, MD
Trial lead · Dana-Farber
Aakash Desai
Aakash Desai
1.3K impressions
Rami Manochakian MD, FASCO
Rami Manochakian MD, FASCO
1.2K impressions
Dr Amol Akhade
Dr Amol Akhade
436 impressions
Yakup Ergün
Yakup Erg n
319 impressions
Balazs Halmos
Balazs Halmos
300 impressions
Toni Choueiri, MD
Toni Choueiri, MD
177 impressions
Uğur Özkerim
U ur zkerim
123 impressions
Dr. Antonio Calles 🫁🚭
Dr. Antonio Calles
100 impressions

DeLLphi-305 Key Slides & Visuals

Topline-day captures (Sept 8, 2026): the study-design slide, the Amgen press release, and the Imdelltra Phase 3 program landscape. Full text via the OCR toggle on each card. No DeLLphi-305 efficacy numbers have been disclosed yet.

Toni Choueiri, MD @DrChoueiri · 2026-09-08
Study design + press-release headline
Design slide (planned n=275 per arm) shared by Dr. Toni Choueiri; OCR = design slide
View Post
DeLLphi-305 — Study design + press-release headline (1)DeLLphi-305 — Study design + press-release headline (2)
DeLLphi-305: Durvalumab ± Tarlatamab 1L Maintenance - International, open-label, randomized phase III study - Adults with ES-SCLC who completed 3-4 cycles of platinum/etoposide with concurrent durvalumab as first-line tx without disease progression - no symptomatic CNS mets - ECOG PS 0-1 → Tarlatamab IV Q2W + Durvalumab IV Q4W (n = 275) → Durvalumab IV Q4W (n = 275) - Primary endpoint: Overall Survival - Secondary endpoints: PFS, ORR, DCR, DoR, TTP, safety, QoL
Aakash Desai @ADesaiMD · 2026-09-08
Amgen press release — full capture
Press release, Sept 8, 2026
View Post
DeLLphi-305 — Amgen press release — full capture
IMDELLTRA® IN COMBINATION WITH IMFINZI® DEMONSTRATED LANDMARK IMPROVEMENT IN OVERALL SURVIVAL IN FIRST-LINE EXTENSIVE STAGE SMALL CELL LUNG CANCER Phase 3 DeLLphi-305 Study Delivered Highly Significant and Clinically Meaningful Overall Survival Benefit Versus Durvalumab Alone Study Also Met Secondary Progression-Free Survival and Objective Response Rate Endpoints THOUSAND OAKS, Calif., Sept. 8, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced landmark results from the Phase 3 DeLLphi-305 study, which met its primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA (tarlatamab-dlle) in combination with AstraZeneca's Imfinzi (durvalumab) compared to durvalumab alone. This study tested IMDELLTRA as a first-line maintenance treatment for people with extensive stage small cell lung cancer (ES-SCLC) whose disease had not progressed following initial treatment with durvalumab, platinum-based chemotherapy and etoposide. The study also demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and objective response rate (ORR) among patients treated with IMDELLTRA in combination with durvalumab. Overall, the safety profile of IMDELLTRA in combination with durvalumab was consistent with the known safety profiles of the individual medicines. No new or unexpected safety signals were identified in DeLLphi-305. The study design included monitoring in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe) following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8. "IMDELLTRA has already revolutionized the standard of survival for patients with extensive stage small cell lung cancer whose disease progressed on or after prior treatment. These landmark results from DeLLphi-305 suggest IMDELLTRA will further revolutionize the standard for survival earlier in the treatment journey and meaningfully shift the treatment paradigm for people facing this devastating disease," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "Despite clinical advances, extensive stage small cell lung cancer remains one of the most aggressive and difficult-to-treat cancers, and substantial improvements in survival are rare, underscoring the importance of these findings." This marks the first Phase 3 study including a Bispecific T-cell Engager (BiTE) therapy to demonstrate an overall survival benefit in the first-line maintenance setting for ES-SCLC.
Madeleine Armstrong @ByMadeleineA · 2026-09-08
Phase 3 trials of Imdelltra — program landscape
OncologyPipeline table shared by Madeleine Armstrong
View Post
DeLLphi-305 — Phase 3 trials of Imdelltra — program landscape
Phase 3 trials of Imdelltra Trial | Setting | Regimen | Primary endpoint(s) | Note Dellphi-304 | 2nd-line ES-SCLC | IV Imdelltra, vs chemo | OS | Supported full approval Nov 2025 Dellphi-305 | 1st-line ES-SCLC (maintenance) | IV Imdelltra + Imfinzi, vs Imfinzi | OS | Completes Jul 2027 (annotated "Win") Dellphi-306 | 1st-line LS-SCLC (maintenance) | IV Imdelltra, vs placebo | PFS & OS (originally PFS only) | Completes Apr 2030 (originally Oct 2026; Imfinzi was approved in this setting in Dec 2024) Dellphi-312 | 1st-line ES-SCLC | IV Imdelltra + Imfinzi + chemo (induction) then Imdelltra + Imfinzi (maintenance), vs Imfinzi + chemo (induction) then Imfinzi (maintenance) | PFS & OS (originally OS only) | Completes Jan 2029 Dellphi-315 | 2nd-line ES-SCLC | SC vs IV Imdelltra | AUC & Ctrough | Estimated start date 31 Aug 2026; completes Sep 2027 Notes: ES=extensive stage; LS=limited stage. Source: OncologyPipeline.

DeLLphi-305 Top Tweets

Laura Alder, MD@LauraAlderMD
𝕏

📣 Changes and progress for tarlatamab in SCLC! ✅ FDA has approved REDUCED monitoring time for the first two doses: 22–24h on C1D1 and C1D8 ➡️ 6–8h. Easing this lowers a key barrier to outpatient and community administration. 🔜 Coming soon: positive overall survival results from the phase III maintenance DeLLphi-305 trial ➡️ soon moving into 1L. 📄 To help teams operationalize all of this, our recent multi-institutional perspective on tarlatamab administration and management of CRS/ICANS provides practical, real-world guidance for safe delivery. 👀 Stay tuned for outpatient-focused delivery and risk management strategies. https://t.co/zXL70ok6Gj @BZhangMD @ADesaiMD @alissajcooper @MehmetAltanMD @Annechiangmd @LaurenByersMD @Sonampuri

1.3K views 20 likes6 RT 2026-09-21
Aakash Desai@ADesaiMD
𝕏

🚨Hot off the press! In #SCLC, tarlatamab plus durvalumab in 1L ES-SCLC shows OS improvement! Looking forward to the full data! @LungCancerRx https://t.co/H4sBvgIkm0

1.3K views 0 likes0 RT 2026-09-08
Rami Manochakian MD, FASCO@RManochakian
𝕏

🚨🔥‼️@OncoAlert Hot off the press. #BigNews #PressRelease by @Amgen ⭐️ #DeLLphi305 phase 3 trial of: ❇️1st line maintenance #Tarlatamab + #Durvalumab) vs #Durvalumab alone in patients with #ExtensiveStage #SmallCell #LungCancer after initial induction Tx with Chemo + Durvalumab. Showed: ✅Statistically Significant & Clinically meaningful ⬆️#OverallSurvival (#OS) Benefit. 👇🏻 https://t.co/qOh6UPlvaU

1.2K views 0 likes0 RT 2026-09-08
Madeleine Armstrong@ByMadeleineA
𝕏

Dellphi-305 trial of Imfinzi + Imdelltra in 1L ES-SCLC maintenance toplined positive. What are the odds this'll be at ESMO? $AZN $AMGN https://t.co/6YObwpSGZ3 https://t.co/rWA8SmpDJw

1.2K views 0 likes0 RT 2026-09-08
Dr Amol Akhade@SuyogCancer
𝕏

🚨 Landmark development in ES-SCLC! Phase 3 DeLLphi-305 has shown a statistically significant and clinically meaningful OS benefit with tarlatamab (IMDELLTRA) + durvalumab versus durvalumab alone as 1L maintenance after platinum–etoposide + durvalumab. PFS and ORR also improved. A potentially important new chapter in ES-SCLC maintenance therapy. Looking forward to full data @StephenVLiu @TejasPatilMD @LauraAlderMD @IASLC

436 views 0 likes0 RT 2026-09-08
Yakup Ergün@dr_yakupergun
𝕏

The kind of news we’ve been waiting for in ES-SCLC: an OS benefit ✅️ First-line maintenance tarlatamab + durvalumab 🔥 https://t.co/yDa6acdBeT

319 views 0 likes0 RT 2026-09-08
Balazs Halmos@BalazsHalmosMD
𝕏

Just one word - starlatamab! A star was born last year at #ASCO25 and looks like now found a steady partner in durvalumab! https://t.co/7YSywJwf60 https://t.co/DAHOJUitwq

300 views 0 likes0 RT 2026-09-08
Toni Choueiri, MD@DrChoueiri
𝕏

JUST IN: DeLLphi-305 study met its primary endpoint of overall survival combining tarlatamab (DLL3 BiTE) with PDL1 inhibitor Durvalumab as maintenance after 1L chemotherapy for extensive-stage small cell lung cancer ! Also RR/PFS significant Trial led by @DanaFarber @sands_jacob ! Via @PRNews https://t.co/mbVxkzeAmz

177 views 0 likes0 RT 2026-09-08
Uğur Özkerim@UOzkerim
𝕏

📢Very exciting news for ES-SCLC! 🔥 DeLLphi-305 meets its primary OS endpoint with tarlatamab + durvalumab as first-line maintenance, with significant improvements also reported in PFS and ORR. Looking forward to seeing the full results! 👀 @OncoAlert @ManuelDomine @GlopesMd @weoncologists @MedwatchHQ @OpenMedKate

123 views 0 likes0 RT 2026-09-08
Dr. Antonio Calles 🫁🚭@Tony_Calles
𝕏

Just received this. The golden era in SCLC! The DeLLphi-305 (Phase 3 Study in First-Line ES-SCLC Following Platinum, Etoposide and Durvalumab) OS Interim Analysis has been conducted. The analysis has demonstrated a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA® (tarlatamab-dlle) in combination with AstraZeneca's Imfinzi® (durvalumab) compared to durvalumab alone. https://t.co/DXLmkDT5Yz

100 views 0 likes0 RT 2026-09-08

About the DeLLphi-305 Trial

Extensive-stage small cell lung cancer almost always relapses after first-line platinum–etoposide plus a PD-L1 inhibitor, and frontline survival gains have been rare. DeLLphi-305 tests whether introducing tarlatamab — a DLL3-targeted Bispecific T-cell Engager (BiTE) — during the maintenance phase, in combination with continued durvalumab, extends survival before relapse occurs.

On September 8, 2026, Amgen announced the study met its primary endpoint at a pre-specified interim analysis, with a statistically significant and clinically meaningful overall survival benefit plus significant PFS and ORR improvements — the first Phase 3 BiTE result in the 1L maintenance setting. The program builds on DeLLphi-301 (accelerated approval, May 2024), the confirmatory DeLLphi-304 (full FDA approval in 2L+, Nov 2025), and the Phase 1b DeLLphi-303, which reported median OS of 25.3 months for tarlatamab plus anti–PD-L1 maintenance at WCLC 2025 — Phase 1b data reported separately from this Phase 3 readout. Physicians on this page framed the readout as a landmark for a disease where, as trial lead Jacob Sands' colleagues note, substantial survival improvements are rare.

Trial Methodology & Results

Study Design

Global (international), randomized (1:1), open-label Phase 3; 563 patients randomized; design slide planned ~275 per arm.

Population

Adults with ES-SCLC who completed 3–4 cycles of platinum/etoposide with concurrent durvalumab as first-line treatment without disease progression; no symptomatic CNS metastases; ECOG PS 0–1.

Interventions

Tarlatamab IV every 2 weeks + durvalumab IV every 4 weeks vs durvalumab IV every 4 weeks, until progression or unacceptable toxicity.

Endpoints

Primary: overall survival. Secondary: PFS, ORR, DCR, DoR, TTP, safety, quality of life.

Mechanism

Tarlatamab directs cytotoxic T cells to DLL3-expressing SCLC cells (BiTE platform); durvalumab maintains PD-L1 checkpoint blockade from induction.

Sponsors

Amgen (tarlatamab); durvalumab supplied as AstraZeneca’s Imfinzi.

Efficacy — topline only

Tarlatamab plus durvalumab delivered a statistically significant and clinically meaningful improvement in overall survival (primary endpoint) at a pre-specified interim analysis, plus statistically significant improvements in PFS and ORR versus durvalumab alone. No hazard ratios, medians, or response rates have been disclosed yet; full data will be presented at an upcoming medical congress and shared with regulators.

First Phase 3 BiTE OS benefit in 1L maintenance ES-SCLC
Source: Amgen press release, Sept 8, 2026

Safety

Per the topline announcement, the combination’s safety profile was consistent with the known profiles of the individual medicines, with no new or unexpected safety signals. The trial design used post-infusion monitoring of 1–2 hours (6–8 hours in certain regions including Europe) on Cycle 1 Day 1 and Day 8 — shorter than the 22–24 hour monitoring tarlatamab’s US label originally required. On September 11, 2026 (BLA 761344/S-002) the FDA reduced the label’s routine monitoring for Cycle 1 Day 1 and Day 8 to 6–8 hours, with patients remaining within 1 hour of an appropriate healthcare setting for 48 hours total; 22–24-hour monitoring is retained after certain Grade ≥2 CRS/ICANS events (FDA label, Sept 2026). Quantitative safety data (CRS/ICANS rates, discontinuations) have not yet been disclosed. Source: IMDELLTRA USPI s002 (Sept 11, 2026) →

Source: Amgen press release, Sept 8, 2026

Clinical Implications

⚠ Investigational in 1L maintenance: the combination is not approved in this setting; Amgen will engage regulators with the interim data. ✅ Tarlatamab is already a fully FDA-approved, NCCN Category 1 preferred standard in 2L+ ES-SCLC (DeLLphi-304: OS 13.6 vs 8.3 months, HR 0.60). If registered on DeLLphi-305, DLL3-targeted BiTE therapy would move a line earlier — changing 1L maintenance from passive checkpoint continuation to active immune redirection, with the rest of the DeLLphi program (306 in LS-SCLC, 312 in 1L induction+maintenance) testing even earlier use.

Source: Amgen, full approval (DeLLphi-304), Nov 19, 2025

DeLLphi-305 in the News

WCLC 2026: Live KOL Reaction

Physician posts about this trial captured live during the IASLC 2026 World Conference on Lung Cancer (Seoul, September 12–15). Quotes are verbatim; each card links to the original post. Last updated 2026-09-22.

Dr. Estela Rodriguez
Dr. Estela Rodriguez@Latinamd

📣 Big news in Small Cell Lung Cancer! #DeLLphi305, a Phase 3 study of #tarlatamab maintenance with chemo-IO + durvalumab in #SCLC 🫁, met its primary endpoint. Bringing tarlatamab to the frontline could improve survival in a disease long marked by therapeutic nihilism. ❓🙋🏽‍♀️how to improve access and ease of administration ( check out #WCLC26 abstract ) ❓how to improve patient selection and minimize toxicity

1.9K impressions16 likes2026-09-08
Misty Dawn Shields
Misty Dawn Shields@drshieldsmd

Thank you Dr. Anne Chiang @Annechiangmd @YaleCancer here at @IASLC #WCLC26 for highlighting our recent biomarker research on durable responders of lurbinectedin that identified ISL1 dependency as a novel neuroendocrine subtype in SCLC that predicts response, published in @MCT_AACR. Given the following growing evidence: 1) the press release with positive OS outcomes with DeLLphi-305 in the 1LM 2) negative confirmatory study with LAGOON (although multiple study design concerns existed, including pts with hx of tx brain mets) 3) sponsor withdrawal of lurbinectedin in the relapsed/refractory setting of ES-SCLC 4) risk for relapsed SCLC treatment gap while awaiting ADC approvals that are limited by ILD, myelosuppression, GI toxicity and acquired resistance development. … the prospective need to apply proposed biomarkers like ISL1 is important to understand who ultimately will benefit from lurbinectedin in their treatment of SCLC. @SclcSMASHERS @LUNGevity @lungoncdoc @weldeiry @OTtheScientist @PareshKumaaar @ktgminton @IUCancerCenter @MoffittNews @OncLive @OncoAlert @oncodaily @LungCancerRx @triparnasen @AparGanti @StephenVLiu

462 impressions9 likes2026-09-13
Masahiro TORASAWA, MD. PhD.
Masahiro TORASAWA, MD. PhD.@M_Torasawa

🚨 DeLLphi-305 is positive! Tarlatamab + durvalumab as 1L maintenance in ES-SCLC significantly improved: 🫁 OS (primary endpoint) 📈 PFS 🎯 ORR vs durvalumab alone, with no new safety signals. 🔥 First Phase 3 BiTE study to show an OS benefit in 1L maintenance ES-SCLC. 🔗 https://t.co/y9NRAeMirT

10.5K impressions70 likes2026-09-08
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🔥DeLLphi-305: "Statistically significant and highly clinically meaningful improvement in overall survival (OS)" 🆙 @Amgen @AstraZeneca 👥Patients: Extensive-stage small cell lung cancer (ES-SCLC), no progression after 1st-line induction with durvalumab + platinum chemotherapy + etoposide 3⃣Phase III ⚖️Tarlatamab + durvalumab ⚖️Durvalumab alone 🔢NCT06211036 #LCSM @OncoAlert @Larvol 🔗 https://t.co/4tFnvnm3UA 🔗 https://t.co/rhf7IGZ1lN

6.0K impressions50 likes2026-09-08
MV Chandrakanth
MV Chandrakanth@ChandrakanthMv

TWO IOs. TWO MAINTENANCE STRATEGIES. ES-SCLC maintenance is evolving. IMforte: Atezolizumab → add lurbinectedin DeLLphi-305: Durvalumab → add tarlatamab Different IO backbones. Different maintenance partners. Different biology. But one emerging strategy: don’t wait for relapse — intensify while the disease is still controlled. Is maintenance becoming the new battleground in ES-SCLC? Cross-trial comparison is conceptual; these strategies were not directly compared. #MVOnco #SCLC #ES_SCLC #IMforte #DeLLphi305 #Lurbinectedin #Tarlatamab #LungCancer #ThoracicOncology

3.5K impressions53 likes2026-09-09
Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu

Very excited to see the full dataset - addition of tarlatamab as first-line maintenance therapy to ES-SCLC in DeLLphi-305 improves PFS and OS. Focus now has to be on implementation, patient selection, and removing barriers. https://t.co/l02noCZ3G5

3.3K impressions51 likes2026-09-08
Dr Rishabh Jain
Dr Rishabh Jain@DrRishabhOnco

🚨 DeLLphi-305: Tarlatamab enters 1L maintenance in ES-SCLC Who was treated? Patients with extensive-stage SCLC who had not progressed after platinum + etoposide + durvalumab. Phase 3 design 563 patients randomized 1:1: Tarlatamab + durvalumab vs Durvalumab alone Primary endpoint: OS Key secondary endpoints: PFS, ORR What was announced? ✅ Statistically significant and clinically meaningful OS benefit ✅ Significant improvement in PFS ✅ Significant improvement in ORR ✅ No new unexpected safety signals reported Why it matters This is the first Phase 3 study of a BiTE therapy to demonstrate an OS benefit in first-line maintenance ES-SCLC. That is a major milestone in a disease where many patients relapse early and never reach second-line therapy. But we still need the numbers • OS hazard ratio • Median OS • Median PFS • Detailed CRS/ICANS rates • Discontinuation and treatment-related mortality data Clinical verdict 🔥 Potentially practice-changing. If the magnitude of OS benefit is substantial and toxicity remains manageable, tarlatamab + durvalumab could become a new first-line maintenance standard in ES-SCLC. #SCLC #LungCancer #Oncology @ASCO @oncoalert

2.7K impressions37 likes2026-09-09
ilyas sahin, MD
ilyas sahin, MD@ilyassahinMD

Potentially practice-changing phase III news in extensive-stage small cell lung cancer. * In DeLLphi-305, adding the DLL3xCD3 T-cell engager tarlatamab to durvalumab maintenance after platinum/etoposide + durvalumab significantly improved overall survival and progression-free survival versus durvalumab alone. Interesting to see T-cell engagers moving earlier in treatment, rather than being reserved for relapse. For now, these are topline results from a company announcement, so the actual hazard ratios, survival curves, and detailed safety data will matter. Looking forward to seeing the full results.

2.3K impressions45 likes2026-09-08
Noemi Reguart
Noemi Reguart@NReguart

A great day for our patients and the entire #SCLC community! 👏👏👏 Thrilled to see the positive results from DeLLphi-305. A landmark achievement in #SCLC! 🎉 https://t.co/DVDlycnuQC

2.2K impressions26 likes2026-09-08
gilberto lopes
gilberto lopes@GlopesMd

Visual summary of today’s phase 3 DeLLphi-305 update in ES-SCLC: tarlatamab + durvalumab maintenance improved OS vs durvalumab alone after induction durvalumab + platinum/etoposide. PFS and ORR also positive. Full data still needed. #SCLC #LCSM https://t.co/pyeQbPyoRc

1.6K impressions22 likes2026-09-08
Dra. María Natalia Gandur Quiroga
Dra. María Natalia Gandur Quiroga@nataliagandur

🚨 Too much oncology news. Too little time. That’s where the @OncoAlert Newsletter really delivers value: filtering the noise and surfacing the data most worth knowing each week. This edition brings together: 🔴 LUNG: DeLLphi-305 with tarlatamab + durvalumab in ES-SCLC, plus new data on lazertinib resistance/ctDNA clearance and osimertinib in uncommon EGFR mutations 🟠 GI: early Phase 1 data with L-glutamine + gemcitabine/nab-paclitaxel in advanced pancreatic cancer 🔵 GU: perioperative strategies in high-risk #ProstateCancer and fracture risk with abiraterone 🟣 BREAST: pCR with neoadjuvant THP in HER2+ disease and biomarkers in stage I TNBC 🌍 And this week also features AcuVox — helping colleagues track the trials, treatments, and topics generating the most attention at major cancer congresses. What I value most is the format: high-yield, clinically relevant, and easy to scan in minutes. 👉 REGISTER TO GET IT: https://t.co/NFi1ia6FQt Stay informed. Focus on what matters. @matteolambe @aftimosp @E_de_Azambuja @DrSGraff @ErikaHamilton9 @double_whammied @maryam_lustberg @raalbany @hoperugo @stolaney1 @LoiSher @JaniceTNBCmets @montypal @DrDanielHeng @apolo_andrea @DrChoueiri @PGrivasMDPhD @TiansterZhang @neerajaiims @amerseburger @sonpavde @drenriquegrande @tompowles1 @cdanicas @nataliagandur @realbowtiedoc @Onco_Cifu88 @scocmem @FernandoOnco @ElisaAgostinett @to_be_elizabeth @Erman_Akkus @MarioBalsaMD @DrMirallas @GIMedOnc @UOzkerim @DrRishabhOnco @PaulJiL @DaisukeKotani @DraMartinezLago @p_ciracimd @BenWestphalen @CentralParkWMD @graokane @amandaNizamMD @DrVilmaPBarcia #OncoAlert #Oncology #CancerResearch #LungCancer #BreastCancer #ProstateCancer #PancreaticCancer

1.4K impressions8 likes2026-09-10
Gil Morgan, MD
Gil Morgan, MD@weoncologists

JUST OUT 🚨 DeLLphi-305 Update in #SCLC 🫁 To Be Presented Soon! Ping @COR2EDMedEd @gotoPER @mirrorsmed @VJOncology @high5md https://t.co/er7POxdu3m

1.1K impressions10 likes2026-09-08
Giannis Mountzios
Giannis Mountzios@g_mountzios

🌟Time to move T-cell engagers to 1st-L maintenance ? A new era is dawning for our patients with #SCLC The much-awaited press-release from DeLLphi-305 confirms that analysis has demonstrated a statistically significant and clinically meaningful improvement in overall survival with tarlatamab in combination with durvalumab compared to durvalumab alone. Full data coming soon! https://t.co/IQnZmYfSuh @SclcSMASHERS @myESMO @IASLC @ASCO @LungCancerEu @OncoAlert @OncBrothers @YoungLungCancer @lcrf_org @PeerView @oncodaily

1.1K impressions19 likes2026-09-08
Oncology Tube
Oncology Tube@oncologytube

DeLLphi-305 met its overall-survival endpoint in 1L ES-SCLC maintenance. Full read: https://t.co/wbcDvWKbYi https://t.co/5l6H3fhneX

1.1K impressions8 likes2026-09-10
Targeted Oncology
Targeted Oncology@TargetedOnc

🔬 DeLLphi-305 data show tarlatamab plus durvalumab significantly improved overall survival as first-line maintenance in extensive stage small cell #LungCancer. Read more: https://t.co/UEmrS0Tcti #SCLC #Oncology #ThoracicOncology #ClinicalTrials #CancerTreatment

847 impressions9 likes2026-09-08
Dipesh Uprety MD FACP
Dipesh Uprety MD FACP@DipeshUpretyMD

DeLLphi-305 — A Phase III study comparing tarlatamab + durvalumab versus durvalumab alone after chemo-IO in ES-SCLC. Per the press release, the study delivered a highly significant and clinically meaningful overall survival benefit with tarlatamab + durvalumab versus durvalumab. A big win and a major milestone for the field of lung cancer #LCSM @OncoAlert https://t.co/wXZq6IxKoS

410 impressions4 likes2026-09-08
The Pharma Letter
The Pharma Letter@ThePharmaLetter

Phase III DeLLphi-305 met its primary endpoint at interim analysis: @Amgen's Imdelltra (tarlatamab-dlle) with @AstraZeneca's Imfinzi (durvalumab) significantly improved overall survival versus durvalumab alone. https://t.co/YD4eIALIKr #Oncology #ClinicalTrials

400 impressions3 likes2026-09-10
FJ ⭐️⭐️+⭐️
FJ ⭐️⭐️+⭐️@pistoto2017

@care_natureme @OncLive @drshieldsmd @IUCancerCenter Considering the potential introduction of #tarlatamab in the 1lm, what would be the optimal treatment regimen—particularly regarding the best use of all available therapeutic options (which are limited)? 1. #Imforte in 1lm + Tarla in 2l 2. #DeLLphi-305 in 1lm + Topotecan in 2l

393 impressions0 likes2026-09-10
MedChemExpress
MedChemExpress@MedChemExpress

🚨Oncology Breakthrough | Can a new combination change the first-line treatment landscape for extensive-stage small cell lung cancer? Phase 3 DeLLphi-305 showed that #tarlatamab-dlle (#IMDELLTRA, Amgen) + #durvalumab (#IMFINZI, AstraZeneca) significantly improved overall survival versus durvalumab alone in the first-line maintenance setting. The combination also improved progression-free survival (PFS) and objective response rate (ORR), marking the first Phase 3 study of a BiTE® therapy to demonstrate an overall survival benefit in this setting. 📰Read more: https://t.co/reOrh9YJJi #SCLC #SmallCellLungCancer #LungCancer #Oncology #CancerResearch #Immunotherapy

319 impressions8 likes2026-09-09
BiotechReality
BiotechReality@biotechreality

Clinical Intelligence | Amgen: IMDELLTRA Imfinzi Combination Delivers Landmark Survival Gain in DeLLphi-305 Trial Full data analysis on BiotechReality: https://t.co/zOsmnF0RCl #Amgen #AstraZeneca #IMDELLTRA #Tarlatamab #Imfinzi #Durvalumab #DeLLphi305 #Phase3Trial #SCLC

59 impressions0 likes2026-09-08
Mason Berger
Mason Berger@biotech_leads

1/5 Amgen says tarlatamab plus durvalumab improved overall survival versus durvalumab alone in first-line extensive stage small cell lung cancer. Phase 3, DeLLphi-305. If it holds up at full presentation, it is the first T-cell engager to win on OS in frontline lung.

46 impressions0 likes2026-09-09
Morning Glory Sciences
Morning Glory Sciences@MorningGlorySci

First OS win for a T-cell engager in first-line ES-SCLC maintenance: phase 3 DeLLphi-305, 563 randomized, primary endpoint met at a prespecified interim analysis. No median, no hazard ratio, no event count, no data cutoff. #LungCancer #ClinicalTrials https://t.co/pWKgfWSQM4

42 impressions0 likes2026-09-08
Wajahat Afaq
Wajahat Afaq@TheWajSpeaks

In late-stage trial results, AstraZeneca’s block-buster cancer drug Imfinzi, combined with Amgen’s targeted immunotherapy Imdelltra, demonstrated a landmark, statistically significant improvement in overall survival for patients with first-line extensive-stage small cell lung cancer. The Phase III DeLLphi-305 study tested this combo therapy as a maintenance treatment following standard chemotherapy. Results showed that the dual-action regimen significantly prolonged patient lives while boosting progression-free survival compared to Imfinzi alone. Crucially, no new safety concerns emerged. Given the historically low survival rates associated with aggressive lung cancers, this break-through marks a pivotal clinical milestone that provides fresh hope to millions worldwide.

21 impressions0 likes2026-09-08
EuropePharmaToday
EuropePharmaToday@eu_pharmatoday

Amgen 8 Sep: DeLLphi-305 topline — tarlatamab + durvalumab beat durvalumab on OS as 1L ES-SCLC maintenance. No numbers. Not a CHMP opinion. EU Imdylltra stays later-line monotherapy.

13 impressions0 likes2026-09-10
Masahiro TORASAWA, MD. PhD.
Masahiro TORASAWA, MD. PhD.@M_Torasawa

A striking timeline in ES-SCLC: 💉 Early 1980s: Platinum–etoposide ⏳ ~4 decades... ✨ 2018–2019: IMpower133 / CASPIAN ⌛️ only ~7–8 years 🔥 2026: DeLLphi-305 — tarlatamab + durvalumab maintenance The pace of progress in SCLC is accelerating!🚀 https://t.co/o8zZAoh6Oc

5.0K impressions34 likes2026-09-08
gilberto lopes
gilberto lopes@GlopesMd

1/3 Big news in #SCLC today. Phase III DeLLphi-305: tarlatamab + durvalumab maintenance improved OS vs durvalumab alone after first-line platinum/etoposide + durvalumab in ES-SCLC. PFS and ORR also positive. Very encouraging—full data will matter.

1.4K impressions15 likes2026-09-08
MV Chandrakanth
MV Chandrakanth@ChandrakanthMv

A NEW MAINTENANCE ERA IN ES-SCLC? DeLLphi-305 brings tarlatamab earlier in the treatment journey. After platinum–etoposide + durvalumab induction, patients without progression were randomized to durvalumab alone vs tarlatamab + durvalumab maintenance. The topline result: OS improved — with PFS and ORR improving too. The key shift? Don’t wait for relapse. Target residual disease during 1L maintenance. Full numerical data awaited. #MVOnco #DeLLphi305 #Tarlatamab #SCLC #LungCancer #ThoracicOncology #MedicalOncology

1.1K impressions6 likes2026-09-09
Manuel Dómine, MD, PhD
Manuel Dómine, MD, PhD@ManuelDomine

MERLIN, Tarlatamab treatment for limited small cell lung cancer in patients in maintenance; a phase II clinical trial in progress. WORLD CONFERENCE ON LUNG CANCER 2026 SEOUL @gecp_org @Hospital_FJD @quironsalud @UAM_Madrid #IIS-FJD @OncoAlert @AEACaP #LCSM #WCLC26 @SCLC https://t.co/lzb9Zxatfl

256 impressions4 likes2026-09-14

DeLLphi-305 FAQ

What is the DeLLphi-305 trial?

DeLLphi-305 (NCT06211036) is a global, randomized, open-label Phase 3 trial testing tarlatamab (IMDELLTRA, Amgen) plus durvalumab (Imfinzi, AstraZeneca) versus durvalumab alone as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) in patients whose disease had not progressed after initial treatment with durvalumab, platinum-based chemotherapy and etoposide. 563 patients were randomized 1:1. The primary endpoint is overall survival; secondary endpoints include PFS, ORR, DCR, DoR, TTP, safety and quality of life.

What did the DeLLphi-305 topline results show?

Per Amgen's September 8, 2026 announcement, the study met its primary endpoint at a pre-specified interim analysis: tarlatamab plus durvalumab demonstrated a statistically significant and clinically meaningful improvement in overall survival versus durvalumab alone, with statistically significant improvements also in progression-free survival and objective response rate. Numeric results (hazard ratios, medians) have not yet been disclosed; detailed data will be presented at an upcoming medical congress. It is the first Phase 3 study of a bispecific T-cell engager to show an overall survival benefit in the first-line maintenance setting for ES-SCLC.

Is tarlatamab plus durvalumab FDA approved for first-line ES-SCLC?

No. The first-line maintenance combination is investigational. Tarlatamab (IMDELLTRA) itself holds full FDA approval (granted November 19, 2025, converting the May 2024 accelerated approval) for ES-SCLC with disease progression on or after platinum-based chemotherapy, based on the DeLLphi-304 trial, and is the NCCN Category 1 preferred option in that second-line setting. Amgen plans to share the DeLLphi-305 data with regulators.

How is tarlatamab given in DeLLphi-305, and what about safety monitoring?

Tarlatamab was given IV every two weeks with durvalumab IV every four weeks, continuing until progression or unacceptable toxicity. Per Amgen, the combination's safety profile was consistent with the known profiles of each medicine with no new or unexpected safety signals; the study design included healthcare-setting monitoring for 1 to 2 hours (6 to 8 hours in certain regions, including Europe) after tarlatamab infusion on Cycle 1 Day 1 and Day 8 - notably shorter than the 22-24 hour monitoring the second-line label originally required. On September 11, 2026 the FDA reduced the label's routine monitoring for Cycle 1 Day 1 and Day 8 to 6-8 hours (patients remain within 1 hour of a healthcare setting for 48 hours total; 22-24 hour monitoring is retained after certain Grade 2 or higher CRS/ICANS events).

Why does DeLLphi-305 matter for small cell lung cancer?

ES-SCLC almost always relapses after first-line chemo-immunotherapy, and survival gains in the frontline setting have been rare and incremental. DeLLphi-305 is the first Phase 3 trial to show that adding a DLL3-targeted bispecific T-cell engager during maintenance extends overall survival before relapse occurs - physicians on this page called it a landmark and a potential new chapter for 1L maintenance therapy, building on the Phase 1b DeLLphi-303 experience (median OS 25.3 months at WCLC 2025, reported separately).

Key KOL Sentiments — DeLLphi-305

KOLComment (verbatim)Sentiment
Aakash Desai 🚨Hot off the press! In #SCLC, tarlatamab plus durvalumab in 1L ES-SCLC shows OS improvement! Looking forward to the full data! @LungCancerRx https://t.co/H4sBvgIkm0 Positive
Dr Amol Akhade 🚨 Landmark development in ES-SCLC! Phase 3 DeLLphi-305 has shown a statistically significant and clinically meaningful OS benefit with tarlatamab (IMDELLTRA) + durvalumab versus durvalumab alone as 1L maintenance after platinum–etoposide + durvalumab. PFS and ORR also improved. A potentially important new chapter in ES-SCLC maintenance therapy. Looking forward to full data @StephenVLiu @TejasPatilMD @LauraAlderMD @IASLC Positive
Yakup Ergün The kind of news we’ve been waiting for in ES-SCLC: an OS benefit ✅️ First-line maintenance tarlatamab + durvalumab 🔥 https://t.co/yDa6acdBeT Positive
Balazs Halmos Just one word - starlatamab! A star was born last year at #ASCO25 and looks like now found a steady partner in durvalumab! https://t.co/7YSywJwf60 https://t.co/DAHOJUitwq Positive
Uğur Özkerim 📢Very exciting news for ES-SCLC! 🔥 DeLLphi-305 meets its primary OS endpoint with tarlatamab + durvalumab as first-line maintenance, with significant improvements also reported in PFS and ORR. Looking forward to seeing the full results! 👀 @OncoAlert @ManuelDomine @GlopesMd @weoncologists @MedwatchHQ @OpenMedKate Positive
Dr. Antonio Calles 🫁🚭 Just received this. The golden era in SCLC! The DeLLphi-305 (Phase 3 Study in First-Line ES-SCLC Following Platinum, Etoposide and Durvalumab) OS Interim Analysis has been conducted. The analysis has demonstrated a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA® (tarlatamab-dlle) in combination with AstraZeneca's Imfinzi® (durvalumab) compared to durvalumab alone. https://t.co/DXLmkDT5Yz Positive
Rami Manochakian MD, FASCO 🚨🔥‼️@OncoAlert Hot off the press. #BigNews #PressRelease by @Amgen ⭐️ #DeLLphi305 phase 3 trial of: ❇️1st line maintenance #Tarlatamab + #Durvalumab) vs #Durvalumab alone in patients with #ExtensiveStage #SmallCell #LungCancer after initial induction Tx with Chemo + Durvalumab. Showed: ✅Statistically Significant & Clinically meaningful ⬆️#OverallSurvival (#OS) Benefit. 👇🏻 https://t.co/qOh6UPlvaU Neutral
Toni Choueiri, MD JUST IN: DeLLphi-305 study met its primary endpoint of overall survival combining tarlatamab (DLL3 BiTE) with PDL1 inhibitor Durvalumab as maintenance after 1L chemotherapy for extensive-stage small cell lung cancer ! Also RR/PFS significant Trial led by @DanaFarber @sands_jacob ! Via @PRNews https://t.co/mbVxkzeAmz Neutral