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- || 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) - Apr 22, 2021
P1b, N=60, Not yet recruiting, Sponsor: Amgen
Trial completion date: Sep 2025 --> Apr 2025 | Trial primary completion date: May 2024 --> Mar 2022
- ||| AMG 757 / Amgen, adagrasib (MRTX849) / Mirati
Listen to the latest #LCConsidered podcast - Dr. @StephenVLiu discusses the important science presented at the recent #ELCC21 with Drs. @EnriquetaFelip and @barlesi. Hear perspectives on adagrasib in #KRAS G12C, CM 9LA, KN 407 & AMG 757! Listen at https://t.co/L99e6zeFKM #lcsm (Twitter) - Apr 6, 2021
- |||| AMG 757 / Amgen
Clinical: .@MLJohnsonMD2, MD, of @SarahCannonDocs discusses the clinical potential of AMG 757 in patients with small cell lung cancer. #lcsm https://t.co/B1i4FILwFh (Twitter) - Mar 30, 2021
- ||||| AMG 757 / Amgen, adagrasib (MRTX849) / Mirati
Miss #ELCC21? I recapped some highlights for Lung Cancer Considered, the official @IASLC podcast, with two of the scientific co-chairs: Drs. @EnriquetaFelip and @barlesi. Tune in next week to hear perspectives on adagrasib in #KRAS G12C, CM 9LA, KN 407 and AMG 757! #LCSM (Twitter) - Mar 29, 2021
- ||||| AMG 757 / Amgen, Rova-T (rovalpituzumab tesirine) / AbbVie, BMS
#ELCC21 One to keep an eye on. DLL3 is selectively expressed on SCLC and LCNE cells and not really normal tissue so makes a good target. Rova-T was too toxic. We will see if AMG 757 is able to leverage this target. @OncoAlert #LCSM (Twitter) - Mar 26, 2021
- |||| AMG 757 / Amgen
#ELCC21 AMG 757 in previously treated #SCLC had a RR of 14% We've seen these responses at #WCLC20 with @teekayowo - responses do seem to occur quickly and can be durable. @fblackhall makes the important point that the study is still in escalation. @OncoAlert #LCSM (Twitter) - Mar 26, 2021
- |||||| AMG 757 / Amgen
P1 data: #ELCC21 Update on AMG 757 by Dr. @fblackhall - this is a DLL3 directed BiTE (bispecific T-cell engager) being explored in #SCLC. This is the first-in-human study and DLL3, due to its selective expression in SCLC, remains an appealing target. @OncoAlert #LCSM (Twitter) - Mar 26, 2021
- ||||| AMG 757 / Amgen
P1 data: Nice discussion of Phase 1 AMG757 @DrSanjayPopat #ELCC21 (Twitter) - Mar 26, 2021
- |||||| AMG 757 / Amgen
Clinical, P1 data, Cytokine release syndrome: DLL3 back in small cell lung cancer? 14% ORR with the bispecific T-cell engager AMG757 targeting DLL3. Promising but high rate of cytokine release syndrome and this is a phase I population, so highly selected, far from our pretreated PS2 patients with SCLC. Need more data!#ELCC21 (Twitter) - Mar 26, 2021
- ||||| AMG 757 / Amgen
P1 data: Phase 1, AMG757 DLL3 targeting in SCLC...By F.Blackhall #ELCC21 (Twitter) - Mar 26, 2021
- |||| AMG 757 / Amgen, adagrasib (MRTX849) / Mirati
#ELCC21 starts Thursday, Mar 25. This virtual lung cancer meeting is complimentary for @IASLC and @myESMO members. Highlights include: MRTX849 in #KRAS G12C, bTMB in CM-9LA, 3y f/u for KN-407, AMG 757 data, and a #SCLC education session with yours truly ;) https://t.co/f4wNqEiSOk (Twitter) - Mar 22, 2021
- AMG 757 / Amgen
[VIRTUAL] A phase 1 study of AMG 757, a half-life extended bispecific T-cell engager [BiTE®] immune therapy against DLL3, in SCLC (Track 10) - Mar 2, 2021 - Abstract #JSMO2021JSMO_954;
- AMG 757 / Amgen
[VIRTUAL] Phase 1 study of AMG 757, a delta-like ligand 3 (DLL3) targeting, half-life extended bispecific T-cell engager immuno-oncology therapy, in small cell lung cancer (SCLC) (Channel 3) - Feb 24, 2021 - Abstract #ELCC2021ELCC_103;
P1
The maximum tolerated dose has not been reached. Dose-finding for monotherapy is ongoing.
- ||||| AMG 757 / Amgen
Video: A phase 1 study of AMG 757 Melissa L. Johnson, MD @MLJohnsonMD2 @SarahRCannon #AMG757 #BiTE #SCLC #LungCancer #Cancer #Research Link To FULL Video: https://t.co/LQ1vjoEDMa (Twitter) - Feb 23, 2021
- ||||||| AMG 757 / Amgen, BI 764532 / Boehringer Ingelheim
Clinical: #TTLC21 Exciting immune-based approaches in #SCLC reviewed by @teekayowo including the DLL3 BiTE AMG-757 - promising efficacy, good tolerability (but watch for cytokine release). BI 764532 is another DLL3 BiTE and GD2 BiTE molecules also in development. #LCSM @IASLC (Twitter) - Feb 20, 2021
- |||| AMG 757 / Amgen
Biomarker, Clinical: Solid design - randomized phase 3 with biomarker enriched population but another example of a promising agent that could not beat topotecan for OS. Disappointing results but DLL3 remains a potential therapeutic target (see AMG-757, a DLL3-BiTE) https://t.co/jpbZJkvWYt (Twitter) - Feb 18, 2021
- AMG 757 / Amgen
[VIRTUAL] Emerging Immunotherapy Approaches (AMG 757, GD-2 CAR & Others) () - Feb 5, 2021 - Abstract #IASLCTTLC2021IASLC-TTLC_67;
- |||||| AMG 757 / Amgen
Clinical: #WCLC20 news: Encouraging phase 1 safety & efficacy data reported for #AMG757, a DLL3-directed BiTE, in pretreated patients with #SCLC. Read our report of the presentation by Taofeek Owonikoko @teekayowo & discussion by @StephenVLiu #IASLC https://t.co/xNHGhQ3fO1 (Twitter) - Feb 4, 2021
- |||||| AMG 757 / Amgen
Biomarker, Clinical, P1 data, IO biomarker, Cytokine release syndrome: DLL3 revival in SCLC? #WCLC20 AMG 757 is a BiTE, a bispecific Ab against CD3-DLL3. Can be seen as a 'light CAR-T'. SCLC pts in phase I are overselected, let's be cautious w data but efficacy signal there (n=52): ORR 14%, DOR 6.2m. Cytokine release syndrome 44%. Biomarkers needed! (Twitter) - Jan 31, 2021
- ||| Imdelltra (tarlatamab) / Amgen
New P1 trial: DeLLpro-300: A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer (clinicaltrials.gov) - Jan 10, 2021
P1b, N=60, Not yet recruiting, Sponsor: Amgen
- AMG 757 / Amgen
[VIRTUAL] A Phase 1 Study of AMG 757, Half-Life Extended Bispecific T-Cell Engager (BiTE®)Immune Therapy Against DLL3, in SCLC (Scientific Program Auditorium) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1927;
P1
Conclusion AMG 757 has acceptable safety at doses of up to 10 mg and shows anti-tumor activity in patients with SCLC. Dose escalation is ongoing.
- AMG 757 / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
[VIRTUAL] AMG 757, a Half-Life Extended Bispecific T-Cell Engager (HLE BiTE® Immune Therapy) Targeting DLL3, for the Treatment of Small Cell Lung Cancer (ePoster Hall) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_664;
P1
The study is open and recruiting patients. ClinicalTrials.gov identifier: NCT03319940.
- || 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) - Dec 10, 2020
P1, N=212, Recruiting, Sponsor: Amgen
ClinicalTrials.gov identifier: NCT03319940. Trial completion date: Aug 2023 --> Feb 2024 | Trial primary completion date: Sep 2022 --> Aug 2023
- ||||| AMG 757 / Amgen
Clinical, Adverse events: AMG 757, a DLL3-directed, half-life extended bispecific T-cell engager, was shown to have a feasible adverse effect profile in patients with small cell lung cancer. @HosseinBorghaei @FoxChaseCancer #lcsm https://t.co/My5zshSdMZ (Twitter) - Nov 16, 2020
- ||||| AMG 757 / Amgen
Clinical: BiTE molecules utilize a patient’s T cells to attack & effectively eradicate cancer cells. AMG 757 engages endogenous T cells and SCLC cells to induce T-cell proliferation and serial lysis followed by apoptosis. @HosseinBorghaei @sitcancer #SITC2020 https://t.co/0SjsH8TcFY (Twitter) - Nov 15, 2020
- ||||| AMG 757 / Amgen
Clinical: DLL3-Directed BiTE, AMG 757 Shows Early Tolerability and Efficacy in Small Cell Lung Cancer @HosseinBorghaei @FoxChaseCancer @sitcancer #SITC2020 https://t.co/kJsvHHwj19 (Twitter) - Nov 12, 2020
- AMG 757 / Amgen
[VIRTURL] AMG 757, a half-life extended bispecific T-cell engager (BiTE®) immune therapy against DLL3 in SCLC: phase 1 interim results () - Oct 24, 2020 - Abstract #SITC2020SITC_1908;
- AMG 757 / Amgen
[VIRTUAL] The DLL3-targeted Half-life Extended Bispecific T Cell Engager (HLE BiTE®) immune-oncology therapy AMG 757 has potent antitumor activity in neuroendocrine cancer () - Oct 14, 2020 - Abstract #SITC2020SITC_1652;
P1
A study of AMG 757 in patients with neuroendocrine prostate cancer is under development based on emerging data from the ongoing phase 1 study.Download figure Open in new tab Download powerpoint Abstract 627 Figure 1 AMG 757 Significantly reduced tumor growth in orthotopic SCLC mouse modelsDownload figure Open in new tab Download powerpoint Abstract 627 Figure 2 AMG 757 Phase 1 study design Conclusions AMG 757 engages and activates T cells to kill DLL3-expressing SCLC and other NET cells in vitro and induces significant antitumor activity against established xenograft tumors in mouse models. These preclinical data support evaluation of AMG 757 in clinical studies of patients with NET.
- AMG 757 / Amgen
[VIRTUAL] AMG 757, a half-life extended bispecific T-cell engager (BiTE®) immune therapy against DLL3 in SCLC: phase 1 interim results () - Oct 14, 2020 - Abstract #SITC2020SITC_1390;
- AMG 757 / Amgen
[VIRTUAL] The DLL3-targeted Half-life Extended Bispecific T Cell Engager (HLE BiTE®) immune-oncology therapy AMG 757 has potent antitumor activity in neuroendocrine cancer () - Oct 14, 2020 - Abstract #SITC2020SITC_917;
P1
A study of AMG 757 in patients with neuroendocrine prostate cancer is under development based on emerging data from the ongoing phase 1 study.Download figure Open in new tab Download powerpoint Abstract 627 Figure 1 AMG 757 Significantly reduced tumor growth in orthotopic SCLC mouse modelsDownload figure Open in new tab Download powerpoint Abstract 627 Figure 2 AMG 757 Phase 1 study design Conclusions AMG 757 engages and activates T cells to kill DLL3-expressing SCLC and other NET cells in vitro and induces significant antitumor activity against established xenograft tumors in mouse models. These preclinical data support evaluation of AMG 757 in clinical studies of patients with NET.
- AMG 757 / Amgen
[VIRTUAL] AMG 757, a half-life extended bispecific T-cell engager (BiTE®) immune therapy against DLL3 in SCLC: phase 1 interim results () - Oct 14, 2020 - Abstract #SITC2020SITC_655;
- || Imdelltra (tarlatamab) / Amgen
Enrollment change: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Aug 31, 2020
P1, N=212, Recruiting, Sponsor: Amgen
These preclinical data support evaluation of AMG 757 in clinical studies of patients with NET. N=162 --> 212
- | AMG 757 / Amgen, AMG 119 / Amgen, Rova-T (rovalpituzumab tesirine) / AbbVie, BMS
Review, Journal: DLL3: an emerging target in small cell lung cancer. (Pubmed Central) - Jun 18, 2020
It is therefore being explored as a potential therapeutic target in SCLC. Here, we review the preclinical and clinical evidence for targeting DLL3 in SCLC and discuss several DLL3-specific therapies being developed for the treatment of SCLC: the antibody-drug conjugate rovalpituzumab tesirine, the bispecific T cell engager immuno-oncology therapy AMG 757, and the chimeric antigen receptor T cell therapy AMG 119.
- AMG 757 / Amgen
Antitumor activity of AMG757, a half-life extended (HLE) bispecific T-cell engager (BiTE®) immune therapy targeting DLL3, in human PDX and orthotopic mouse models of small cell lung cancer (SCLC) (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1565;
P1
AMG 757 antitumor activity was associated with increased CD8+ T-cell infiltration as assessed by flow cytometry and IHC and upregulation of the T cell surface activation markers CD25, CD69, PD-1, and 4-1BB as assessed by flow cytometry. Together, these preclinical data demonstrate that AMG 757 can recruit and engage T cells to tumors, consistent with the BiTE® mechanism of action, and that AMG 757-mediated redirected T-cell lysis can drive significant antitumor activity in established SCLC tumor models.
- AMG 757 / Amgen
[VIRTUAL] Phase I study of AMG 757, a half-life extended bispecific T-cell engager (HLE BiTE immune therapy) targeting DLL3, in patients with small cell lung cancer (SCLC). (Poster Board 273) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2348;
P1
The study is open and recruiting patients. Research Funding: Amgen Inc.
- AMG 757 / Amgen, AMG 119 / Amgen
AMG 757 (DLL3) + AMG 119 (DLL3) (CAR-T) (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_90;
- || 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) - Dec 10, 2019
P1, N=132, Recruiting, Sponsor: Amgen
Research Funding: Amgen Inc. Trial completion date: Jul 2022 --> Jun 2023 | Trial primary completion date: Jul 2021 --> Jun 2022
- | Imdelltra (tarlatamab) / Amgen
Enrollment change, 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 26, 2019
P1, N=132, Recruiting, Sponsor: Amgen
Trial completion date: Jul 2022 --> Jun 2023 | Trial primary completion date: Jul 2021 --> Jun 2022 N=92 --> 132 | Trial completion date: Jul 2021 --> Jul 2022
- || 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 6, 2018
P1, N=92, Recruiting, Sponsor: Amgen
N=92 --> 132 | Trial completion date: Jul 2021 --> Jul 2022 Trial completion date: Apr 2021 --> Jul 2021 | Trial primary completion date: Apr 2021 --> Jul 2021
- || Imdelltra (tarlatamab) / Amgen
Trial completion date, Trial initiation date: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Mar 3, 2018
P1, N=92, Recruiting, Sponsor: Amgen
Trial completion date: Apr 2021 --> Jul 2021 | Trial primary completion date: Apr 2021 --> Jul 2021 Trial completion date: Apr 2022 --> Apr 2021 | Initiation date: Jan 2018 --> Dec 2017
- ||| Imdelltra (tarlatamab) / Amgen
Enrollment open: DeLLphi-300: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Jan 26, 2018
P1, N=92, Recruiting, Sponsor: Amgen
Trial completion date: Apr 2022 --> Apr 2021 | Initiation date: Jan 2018 --> Dec 2017 Not yet recruiting --> Recruiting
- || 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) - Dec 12, 2017
P1, N=92, Not yet recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Trial primary completion date: Jul 2021 --> Apr 2021
- ||| tarlatamab (AMG 757) / Amgen
Clinical: Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer (clinicaltrials.gov) - Oct 24, 2017
P1, N=92, Not yet recruiting, Sponsor: Amgen