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- |||||| tarlatamab (AMG 757) / Amgen
P1 data: Let’s have a BITE on #SCLC. @HosseinBorghaei presents updated data on Phase 1 trial with Tarlatamab (DLL3-targeted T-cell Engager) encouraging results with some long-lasting responses in a very difficult to treat scenario. #WCLC22 #LCSM (Twitter) - Aug 8, 2022
- |||| tarlatamab (AMG 757) / Amgen
#WCLC22 Confirmed RR tarlatamab in SCLC was 23% including 2% with CR. Some durable responses noted and median DOE 13mm with most ongoing. Encouraging PFS and even more encouraging OS over 13m in a heavily pretreated population but need to watch CRS. (Twitter) - Aug 8, 2022
- ||| tarlatamab (AMG 757) / Amgen
Toxicity with tarlatamab - seems tolerable but relatively high rates of CRS, though low grade. Neurological events seen in 50% seems high, though largely G1. #WCLC22 (Twitter) - Aug 8, 2022
- |||| tarlatamab (AMG 757) / Amgen
Dr. @HosseinBorghaei presents update from DeLLphi-300 exploring tarlatamab (AMG757) in #SCLC. Median f/u 8.5m in this update with 106pts. Heavily pretreated population. #WCLC22 (Twitter) - Aug 8, 2022
- ||||| tarlatamab (AMG 757) / Amgen
We spoke with @HosseinBorghaei at #WCLC22 who discussed tarlatamab, a novel BiTE under evaluation in #SCLC @IASLC #LungCancer #LCsm (Twitter) - Aug 7, 2022
- || Imdelltra (tarlatamab-dlle) / Amgen
Trial completion date, Trial primary completion date: DeLLphi-301: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Aug 4, 2022
P2, N=160, Recruiting, Sponsor: Amgen
Trial completion date: Aug 2024 --> Nov 2024 | Trial primary completion date: Sep 2023 --> Jun 2023
- tarlatamab (AMG 757) / Amgen
DeLLphi-303: Phase Ib first-line combination study of tarlatamab, a DLL3-targeting half-life extended bispecific T-cell engager (HLE BiTE®), with carboplatin, etoposide, and PD-L1 inhibition in extensive stage small cell lung cancer (ES-SCLC) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_1887;
P1, P1b
The primary objective is to evaluate the safety, tolerability, and determine the recommended phase 2 dose and/or maximum tolerated dose of tarlatamab in combination with PD-L1 inhibition with or without chemotherapy. Secondary endpoints are objective response rate, duration of response, disease control, progression-free survival, overall survival, and pharmacokinetics.
- |||||| tarlatamab (AMG 757) / Amgen
Cytokine release syndrome: Excited to hear more about tarlatamab, the DLL3/CD3 bispecific T-cell engager for #SCLC. Overview by Dr. @RamalingamMD at #DAVAHawaiiLung - main toxicity of concern is cytokine release syndrome. Low grade thus far - need to watch as the study expands. (Twitter) - Jul 7, 2022
- tarlatamab (AMG 757) / Amgen
Phase 1 Updated Exploration and First Expansion Data for DLL3-targeted T-cell Engager Tarlatamab in Small Cell Lung Cancer (Hall C8) - Jun 24, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_715;
P1, P2
The PFS/OS compares well to other therapies currently available for relapsed SCLC. A phase 2 study of tarlatamab in 3L+ SCLC (NCT05060016) is enrolling based on these results.
- || Imdelltra (tarlatamab) / Amgen
Trial primary completion date: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Jun 23, 2022
P1, N=382, Recruiting, Sponsor: Amgen
A phase 2 study of tarlatamab in 3L+ SCLC (NCT05060016) is enrolling based on these results. Trial primary completion date: Jan 2024 --> Feb 2025
- || Imdelltra (tarlatamab) / Amgen
Trial completion date, Trial primary completion date: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Jun 2, 2022
P1, N=382, Recruiting, Sponsor: Amgen
Trial primary completion date: Jan 2024 --> Feb 2025 Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Sep 2023 --> Jan 2024
- ||| Imdelltra (tarlatamab-dlle) / Amgen
New P1 trial, Combination therapy: DeLLphi-303: First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (clinicaltrials.gov) - May 4, 2022
P1b, N=208, Not yet recruiting, Sponsor: Amgen
- tarlatamab (AMG 757) / Amgen
Tarlatamab (AMG757) in SCLC (Gallery B virtually available) - May 1, 2022 - Abstract #OeGHOAHOP2022OeGHO_AHOP_266;
Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Sep 2023 --> Jan 2024 Sponsored By AMGEN
- tarlatamab (AMG 757) / Amgen
Phase 2 study of tarlatamab, a DLL3-targeting, half life–extended, bispecific T-cell engager (HLE BiTE) immuno-oncology therapy, in relapsed/refractory small cell lung cancer (SCLC). (Available On Demand; 222a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5675;
P1, P2
Secondary objectives are to evaluate antitumor activity by additional measures (duration of response, progression-free survival, disease control rate and duration, overall survival), safety and tolerability, immunogenicity, and pharmacokinetics. Sites in North America, Asia and Europe are participating in the trial with subjects already enrolled and enrollment ongoing.
- | Imdelltra (tarlatamab) / Amgen, zeluvalimab (AMG 404) / Amgen
Trial completion date, Trial primary completion date, Combination therapy: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Mar 11, 2022
P1b, N=50, Recruiting, Sponsor: Amgen
Sites in North America, Asia and Europe are participating in the trial with subjects already enrolled and enrollment ongoing. Trial completion date: Mar 2024 --> Oct 2025 | Trial primary completion date: May 2023 --> Aug 2023
- tarlatamab (AMG 757) / Amgen
Delta-like ligand 3 immunohistochemical expression landscape in high-grade lung neuroendocrine tumors (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6758;
Because of its high expression in neuroendocrine tumors compared to normal tissue, delta-like ligand 3 (DLL3) has emerged as a new therapeutic target in this setting.1,2 Targeting DLL3 with the half-life extended bispecific T cell engager (HLE BiTE®) immune therapy, tarlatamab, in a phase 1 clinical trial has demonstrated promising anti-tumor activity in small cell lung cancer (SCLC) patients.3 In order to more precisely guide patient selection and clinical trial design, a better understanding and quantification of DLL3 expression is required...Our work confirms that most high-grade neuroendocrine tumors express DLL3 across histology types and TNM stage. Our results suggest that a large subset of patients with high-grade lung neuroendocrine tumors may be a target population of interest for DLL3-targeted therapies.
- ||||| tarlatamab (AMG 757) / Amgen
Clinical: Is there any update on the efficacy of AMG 757 on SCLC since this poster? Do you think DLL3 is a perfect target to treat SCLCs ? (Twitter) - Mar 8, 2022
- |||||| tarlatamab (AMG 757) / Amgen
Phase 1b study of tarlatamab, a half-life extended bispecific T-cell engager (HLE BiTE Immune Therapy) targeting DLL3, in de novo or treatment-emergent neuroendocrine #ProstateCancer. Presented by Rahul Aggarwal, MD @UCSFCancer > https://t.co/Viy3UE6yMy @zklaassen_md #GU22 @ASCO (Twitter) - Mar 4, 2022
- ||||| Dr. @teekayowo reviews some novel immunotherapy approaches in #SCLC. Taralatamab (AMG 757) is a bispecific (CD3/DLL3) showing early activity (watch for CRS). Tiragolumab being explored with atezolizumab in 1L SKYSCRAPER-02 trial. Vorolanib (VEGF) disappointing in early study. (Twitter) - Feb 26, 2022
- | Imdelltra (tarlatamab) / Amgen, zeluvalimab (AMG 404) / Amgen
Trial completion date, Combination therapy: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Feb 21, 2022
P1b, N=50, Recruiting, Sponsor: Amgen
Our results suggest that a large subset of patients with high-grade lung neuroendocrine tumors may be a target population of interest for DLL3-targeted therapies. Trial completion date: Mar 2025 --> Mar 2024
- tarlatamab (AMG 757) / Amgen
Phase II study of tarlatamab, a half-life extended bispecific T-cell engager (HLE BiTE®) immuno-oncology therapy targeting DLL3, in third-line or later small cell lung cancer (SCLC) ([VIRTUAL]) - Feb 19, 2022 - Abstract #ELCC2022ELCC_416;
P1, P2
Secondary objectives are to evaluate antitumor activity by additional measures (duration of response, progression-free survival, disease control rate and duration, overall survival), safety and tolerability, immunogenicity, and pharmacokinetics. Enrollment has begun.
- | tarlatamab (AMG 757) / Amgen
Preclinical, Journal: AMG 757, a Half-Life Extended, DLL3-Targeted Bispecific T-Cell Engager, Shows High Potency and Sensitivity in Preclinical Models of Small Cell Lung Cancer. (Pubmed Central) - Feb 11, 2022
Enrollment has begun. AMG 757 has a compelling safety and efficacy profile in preclinical studies making it a viable option for targeting DLL3-expressing SCLC tumors in the clinical setting.
- tarlatamab (AMG 757) / Amgen, vorolanib (X-82) / Tyrogenex
Novel Immunotherapy Approaches (AMG 757, Tirogolumab, Vorolanib) ([VIRTUAL]) - Jan 11, 2022 - Abstract #IASLCTTLC2022IASLC_TTLC_96;
- || Imdelltra (tarlatamab) / Amgen
Trial primary completion date: DeLLpro-300: A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer (clinicaltrials.gov) - Jan 11, 2022
P1b, N=60, Recruiting, Sponsor: Amgen
AMG 757 has a compelling safety and efficacy profile in preclinical studies making it a viable option for targeting DLL3-expressing SCLC tumors in the clinical setting. Trial primary completion date: Mar 2023 --> Jul 2023
- ||| Imdelltra (tarlatamab-dlle) / Amgen
Enrollment open: DeLLphi-301: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Jan 11, 2022
P2, N=160, Recruiting, Sponsor: Amgen
Trial primary completion date: Mar 2023 --> Jul 2023 Not yet recruiting --> Recruiting
- tarlatamab (AMG 757) / Amgen
Phase 1b study of tarlatamab, a half-life extended bispecific T-cell engager (HLE BiTE immune therapy) targeting DLL3, in de novo or treatment emergent neuroendocrine prostate cancer (NEPC). (In-Person & On Demand | Level 1, West Hall) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_217;
P1, P1b
Secondary objectives are to evaluate antitumor activity (as assessed by objective response, duration of response, progression-free survival, overall survival, and disease control rate) and characterize pharmacokinetics. Four US and international study sites have been activated with two enrolled pts.
- |||||| tarlatamab (AMG 757) / Amgen
Clinical: DLL3-targeted therapy – recruiting AMG 757 – half-life extended (HLE) bispecific T cell engager (BiTE®) molecule ▶️ Acceptable safety profile ▶️ Rapid & durable response ▶️ Encouraging antitumor activity #SCLCchat (Twitter) - Dec 6, 2021
- | Imdelltra (tarlatamab) / Amgen
Trial completion date: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Nov 11, 2021
P1, N=332, Recruiting, Sponsor: Amgen
Four US and international study sites have been activated with two enrolled pts. Trial completion date: Jan 2025 --> Aug 2024
- | Imdelltra (tarlatamab) / Amgen, zeluvalimab (AMG 404) / Amgen
Trial primary completion date, Combination therapy: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Nov 3, 2021
P1b, N=50, Recruiting, Sponsor: Amgen
Trial completion date: Jan 2025 --> Aug 2024 Trial primary completion date: Mar 2025 --> Mar 2023
- || Imdelltra (tarlatamab) / Amgen
Trial primary completion date: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Oct 15, 2021
P1, N=332, Recruiting, Sponsor: Amgen
Trial primary completion date: Mar 2025 --> Mar 2023 Trial primary completion date: Jun 2024 --> Jul 2023
- || Imdelltra (tarlatamab) / Amgen, zeluvalimab (AMG 404) / Amgen
Enrollment open, Combination therapy: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Oct 6, 2021
P1b, N=50, Recruiting, Sponsor: Amgen
Trial primary completion date: Jun 2024 --> Jul 2023 Not yet recruiting --> Recruiting
- | Imdelltra (tarlatamab) / Amgen
Trial completion date: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Sep 30, 2021
P1, N=332, Recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Trial completion date: Jun 2024 --> Jan 2025
- |||| Imdelltra (tarlatamab-dlle) / Amgen
New P2 trial: DeLLphi-301: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Sep 27, 2021
P2, N=160, Not yet recruiting, Sponsor: Amgen
- |||||| AMG 757 / Amgen
P1 data: #WCLC21 Overview of emerging data on tarlatamab (AMG 757, Bispecific T-cell Engager - BiTE) in #SCLC by Dr. Afshin Dowlati. AMG 757 targets DLL3 and CD3. Mechanism outlined by Afshin here. Phase I dose escalation study ongoing with 66pts enrolled to date. (Twitter) - Sep 11, 2021
- || AMG 757 / Amgen
For tarlatamab (AMG 757), not since #ASCO21 (Twitter) - Sep 8, 2021
- ||| AMG 757 / Amgen, Rybrevant (amivantamab-vmjw) / Genmab, J&J, zenocutuzumab (MCLA-128) / Merus
Bispecific antibodies have become an interesting new class of agents in the lung cancer pipeline, most recently with the developments of amivantamab-vmjw, zenocutuzumab, and tarlatamab @giorgioscaglio3 @gotoPER #ILCC2021 #lcsm https://t.co/3CPzBIAYpy (Twitter) - Aug 6, 2021
- |||||| AMG 757 / Amgen, Zepzelca (lurbinectedin) / PharmaMar, Jazz
Clinical: #LCLive21 Dr. @teekayowo covers second line therapy for #SCLC including lurbinectedin, topotecan, platinum retreatment and tarlatamab as well as disappointments with later line immunotherapy. Great overview #LCSM (Twitter) - Aug 5, 2021
- tarlatamab (AMG 757) / Amgen
[VIRTUAL] Phase Ib study of AMG 757, a half-life extended bispecific T-cell engager immuno-oncology therapy, combined with AMG 404, an anti-PD-1 antibody, in patients with small cell lung cancer (SCLC) () - Jul 22, 2021 - Abstract #ESMO2021ESMO_2920;
P1b
During dose exploration, a modified toxicity probability interval design will be used for decision rules. The study (NCT04885998) is open and recruiting patients.
- ||| Imdelltra (tarlatamab) / Amgen
Enrollment open, Trial completion date: DeLLpro-300: A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer (clinicaltrials.gov) - Jun 30, 2021
P1b, N=60, Recruiting, Sponsor: Amgen
The study (NCT04885998) is open and recruiting patients. Not yet recruiting --> Recruiting | Trial completion date: Mar 2024 --> Jun 2025
- ||||| AMG 757 / Amgen
Updated data from AMG757, Tarlatamab in ext stage SCLC presented by @teekayowo #SCLC RR 20% Overall DCR 30% Seen across tx doses Median DoR 8.7 mos CRS was main AE #PromisingResults #ASCO21 @ASCO (Twitter) - Jun 5, 2021
- ||||| AMG 757 / Amgen
AMG757 is a BITE targeting DLL3 in SCLC. Interesting ORR of 20% with median DOR 8.7m (N=66), toxicity to be optimized: Grade 3 tt-Related AE 27%, CRS 44% ( 2% G3) #ASCO21 (Twitter) - Jun 5, 2021
- |||| AMG 757 / Amgen
#ASCO21 AMG 757 (tarlatamab) was effective in this pretreated #SCLC population. Confirmed RR 20% is impressive and this is still in escalation. Durability more impressive with median DOR 8.7m. These are encouraging data and look forward to more updates. (Twitter) - Jun 4, 2021
- ||||| AMG 757 / Amgen, Rova-T (rovalpituzumab tesirine) / AbbVie, BMS
#ASCO21 Update on AMG 757 (now tarlatamab) in #SCLC presented by Dr. @teekayowo. AMG 757 is a BiTE that targets DLL3, a notch ligand very highly expressed on SCLC/LCNE but not normal tissue. Rova-T targeted DLL3 but was too toxic. How will AMG 757 fare? @OncoAlert #LCSM (Twitter) - Jun 4, 2021
- || Imdelltra (tarlatamab) / Amgen
Trial completion date, Trial primary completion date: DeLLpro-300: A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer (clinicaltrials.gov) - May 25, 2021
P1b, N=60, Not yet recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting | Trial completion date: Mar 2024 --> Jun 2025 Trial completion date: Apr 2025 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Mar 2023
- || Imdelltra (tarlatamab) / Amgen
Enrollment change, Trial completion date, Trial primary completion date: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - May 24, 2021
P1, N=332, Recruiting, Sponsor: Amgen
Trial completion date: Apr 2025 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Mar 2023 N=212 --> 332 | Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Aug 2023 --> Jun 2024
- ||||| AMG 757 / Amgen
Video: VIDEO: Update from a phase 1 study of AMG 757 in #SCLC w/ @DrSanjayPopat of @royalmarsdenNHS Watch here 👉 https://t.co/rEWo4wPIrx👈 @VJOncology @OncoAlert @myESMO @IASLC #ELCC21 #LungCancer #LCsm #OncoAlert #MedOnc #ClinOnc #NCRM21 #ResearchSavesLives (Twitter) - May 22, 2021
- | AMG 757 / Amgen
And/or target de-risking data for competitors (think Harpoon vs AMG757) (Twitter) - May 21, 2021
- || Imdelltra (tarlatamab) / Amgen, zeluvalimab (AMG 404) / Amgen
New P1 trial, Combination therapy: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - May 12, 2021
P1b, N=40, Not yet recruiting, Sponsor: Amgen
- AMG 757 / Amgen
[VIRTUAL] Phase 1b study of AMG 757, a half-life extended bispecific T-cell engager (HLE BiTE immune-oncology therapy) targeting DLL3, in de novo or treatment emergent neuroendocrine prostate cancer (NEPC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2846;
P1, P1b
The starting dose for dose exploration will be based on the dose deemed safe and tolerable in the ongoing trial of AMG 757 in SCLC . The study is open to enrollment.
- AMG 757 / Amgen
[VIRTUAL] Updated results from a phase 1 study of AMG 757, a half-life extended bispecific T-cell engager (BiTE) immuno-oncology therapy against delta-like ligand 3 (DLL3), in small cell lung cancer (SCLC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1718;
P1
Responses were rapid and durable . Encouraging anti-tumor activity was seen across dose ranges, with ongoing unconfirmed PR in 5/8 pts (63%) at the highest DL .