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- || amcenestrant (SAR439859) / Sanofi
Trial completion date, Monotherapy, Metastases: AMEERA-3: Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (clinicaltrials.gov) - Apr 23, 2024
P2, N=367, Active, not recruiting, Sponsor: Sanofi
Trial completion date: Mar 2024 --> Sep 2024
- || amcenestrant (SAR439859) / Sanofi
P1/2 data, Journal, Metastases: Joint modeling of tumor dynamics and progression-free survival in advanced breast cancer: Leveraging data from amcenestrant early phase I-II trials. (Pubmed Central) - Apr 1, 2024
We demonstrated that the instantaneous rate of change in TS (TS slope) was an important predictor of PFS and the developed joint model was able to predict well the PFS of amcenestrant phase II monotherapy trial using only early phase I-II data. This provides a good modeling and simulation tool to inform early development decisions.
- || amcenestrant (SAR439859) / Sanofi
Trial completion date, Monotherapy, Metastases: AMEERA-3: Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (clinicaltrials.gov) - Feb 15, 2024
P2, N=367, Active, not recruiting, Sponsor: Sanofi
This provides a good modeling and simulation tool to inform early development decisions. Trial completion date: Dec 2023 --> Mar 2024
- | amcenestrant (SAR439859) / Sanofi
Journal: AMEERA-4: a randomized, preoperative window-of-opportunity study of amcenestrant versus letrozole in early breast cancer. (Pubmed Central) - Nov 15, 2023
P2
Trial completion date: Dec 2023 --> Mar 2024 Both amcenestrant and letrozole demonstrated antiproliferative activity in postmenopausal women with previously untreated, operable ER+/HER2- breast cancer and had good overall tolerability.
- || amcenestrant (SAR439859) / Sanofi
Trial completion date, Monotherapy, Metastases: AMEERA-3: Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (clinicaltrials.gov) - Aug 25, 2023
P2, N=290, Active, not recruiting, Sponsor: Sanofi
Both amcenestrant and letrozole demonstrated antiproliferative activity in postmenopausal women with previously untreated, operable ER+/HER2- breast cancer and had good overall tolerability. Trial completion date: Sep 2023 --> Dec 2023
- Second generation oral selective estrogen receptor degraders (SERDs) in breast cancer: A systematic review and meta-analysis of clinical trials () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2088;
Table: 481P Characterization of ESR1mut and response to SERD (Amcenestrant, Elacestrant, and Camizestrant) Conclusions Our study supports the favorable safety profile of the new generation oral SERD and presents its efficacy according to ESR1mut. Further studies shall assess the potential biomarker role of individual ESR1mut.
- || amcenestrant (SAR439859) / Sanofi
P2 data, Journal, Monotherapy, Metastases: AMEERA-3: Randomized Phase II Study of Amcenestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Monotherapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. (Pubmed Central) - Jun 22, 2023
P2
AMEERA-3 did not meet its primary objective of improved PFS with amcenestrant versus TPC although a numerical improvement in PFS was observed in patients with baseline ESR1 mutation. Efficacy and safety with amcenestrant were consistent with the standard of care for second-/third-line ET for ER+/HER2- aBC.
- | amcenestrant (SAR439859) / Sanofi
Trial completion date, Monotherapy, Metastases: AMEERA-2: Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (clinicaltrials.gov) - Jun 7, 2023
P1, N=10, Active, not recruiting, Sponsor: Sanofi
Efficacy and safety with amcenestrant were consistent with the standard of care for second-/third-line ET for ER+/HER2- aBC. Trial completion date: May 2023 --> Nov 2023
- ||||||||| amcenestrant (SAR439859) / Sanofi
Trial termination, Metastases: AMEERA-5: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (clinicaltrials.gov) - Jun 2, 2023
P3, N=1068, Terminated, Sponsor: Sanofi
Active, not recruiting --> Terminated; The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.
- ||| amcenestrant (SAR439859) / Sanofi
Trial completion date, Metastases: AMEERA-5: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (clinicaltrials.gov) - May 18, 2023
P3, N=1068, Active, not recruiting, Sponsor: Sanofi
No new safety signals were observed. Trial completion date: Dec 2023 --> May 2023
- amcenestrant (SAR439859) / Sanofi, Orserdu (elacestrant) / Menarini
Efficacy of oral selective estrogen receptor degraders (SERD)s in the treatment of estrogen receptor positive (ER+), HER2-negative metastatic breast cancer (MBC): A stratified analysis of the ESR1 wild type (wt) and mutant (mt) subgroups. (On Demand | Hall A; Poster Bd # 317) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3288;
These findings are in line with the recent FDA approval of Elacestrant for patients with ESR1mt tumours. >
- || amcenestrant (SAR439859) / Sanofi
Clinical, P1 data, Clinical Trial,Phase II, Journal, Metastases: Phase 1 study of oral selective estrogen receptor degrader (SERD) amcenestrant (SAR439859), in Japanese women with ER-positive and HER2-negative advanced breast cancer (AMEERA-2). (Pubmed Central) - Apr 24, 2023
P1
> Amcenestrant 400
- Oral Selective Estrogen Receptor Degraders for metastatic hormone receptor-positive, HER2 negative breast cancer according to ESR1 mutation: a systematic review and meta-analysis of randomized control trials. (Exhibition area) - Mar 22, 2023 - Abstract #ESMOBC2023ESMO_BC_474;
ORR was 11% in patients treated with SERDs and 7.4% in SOC ET (p=0,06). Conclusions Oral SERDs improved PFS compared to SOC ET for ESR1mut HR+/HER2 negative metastatic breast cancer, but not for unselected patients.
- amcenestrant (SAR439859) / Sanofi, giredestrant (GDC-9545) / Roche
The role of ELF3 in acquired resistance to endocrine therapy in ER-positive breast cancer (Section 16; Poster Board #13) - Mar 14, 2023 - Abstract #AACR2023AACR_6118;
However, fulvestrant has poor pharmacokinetic properties, which has inspired the development of a new generation of oral SERDs including amcenestrant and giredestrant...Pathway analysis of ELF3-targeted genes reveals that ELF3 may regulate cell metabolism specifically in SERD resistant cells but not in parental cells. Our study suggests that ELF3 may be a novel driver of acquired resistance to SERDs in ER+ breast cancer.
- || amcenestrant (SAR439859) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: AMEERA-1: Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (clinicaltrials.gov) - Jan 26, 2023
P1/2, N=136, Active, not recruiting, Sponsor: Sanofi
Our study suggests that ELF3 may be a novel driver of acquired resistance to SERDs in ER+ breast cancer. Trial completion date: Dec 2023 --> Dec 2027 | Trial primary completion date: Dec 2023 --> Dec 2027
- ||||| amcenestrant (SAR439859) / Sanofi
Clinical: Oral SERD landscape #sabcs22 📌We have data from 4/5 studies ➡️ 2 ➕studies and 2➖ve studies. 📌 Amcenestrant no longer in development 📌 the difference in study results secondary to breast endocrine resistant/sensitive pts & ESR1mut/wt @OncoAlert (Twitter) - Dec 8, 2022
- Available findings with the use of other oral SERDs (eg, camizestrant, imlunestrant, giredestrant, amcenestrant) (San Antonio Marriott Rivercenter, Grand Ballroom G-M, Third Floor) - Nov 22, 2022 - Abstract #SABCS2022SABCS_2163;
- | amcenestrant (SAR439859) / Sanofi
Trial completion date, Monotherapy, Metastases: AMEERA-2: Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (clinicaltrials.gov) - Nov 17, 2022
P1, N=10, Active, not recruiting, Sponsor: Sanofi
Trial completion date: Dec 2023 --> Dec 2027 | Trial primary completion date: Dec 2023 --> Dec 2027 Trial completion date: Nov 2022 --> May 2023
- | amcenestrant (SAR439859) / Sanofi, giredestrant (GDC-9545) / Roche
Why did $SNY & $RHHBY Serds fail? Amcenestrant prob a PK issue. Giredestrant less clear, but had to reduce the dose. Per S Bohen $OLMA @ #Jefferies22 (Twitter) - Nov 16, 2022
- | amcenestrant (SAR439859) / Sanofi, elacestrant (RAD1901) / Menarini
Journal: Leading Oral SERD Shows Prolonged Activity. (Pubmed Central) - Nov 4, 2022
But not all oral selective estrogen receptor degraders have demonstrated impressive efficacy. In August, Sanofi announced that it was ending development of amcenestrant after an interim analysis of a pivotal phase III trial found that the study would likely end in failure.
- amcenestrant (SAR439859) / Sanofi
Trial completion date, Trial termination, Trial primary completion date: AMEERA-6: Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity (clinicaltrials.gov) - Oct 24, 2022
P3, N=3, Terminated, Sponsor: Sanofi
In August, Sanofi announced that it was ending development of amcenestrant after an interim analysis of a pivotal phase III trial found that the study would likely end in failure. Trial completion date: Feb 2034 --> Oct 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Oct 2022; Sponsor decision to prematurely stop the study, not linked to any safety concern
- | amcenestrant (SAR439859) / Sanofi, giredestrant (GDC-9545) / Roche, elacestrant (RAD1901) / Menarini
Journal: Integrating new oral selective oestrogen receptor degraders in the breast cancer treatment. (Pubmed Central) - Oct 15, 2022
Promising results from early-phase trials are not translating into sufficient clinical benefit in pivotal trials of main oral SERDs in monotherapy, except for elacestrant. Whether oral SERDs might become the backbone for combination strategies in MBC or the preferred (neo)adjuvant endocrine agents is under evaluation.
- amcenestrant (SAR439859) / Sanofi
AMEERA-6: Phase 3 study of adjuvant Amcenestrant versus Tamoxifen for patients with hormone receptor-positive early breast cancer, who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1643;
P3
AMEERA-6 recruited the first patient in March 2022 and is being conducted in partnership with AFT, BIG, EORTC, and Sanofi. Clinical trial information: NCT05128773
- amcenestrant (SAR439859) / Sanofi, Verzenio (abemaciclib) / Eli Lilly
Characterization of residual disease after neoadjuvant selective estrogen receptor degrader (SERD) therapy using tumor organoids in the I-SPY Endocrine Optimization Protocol (EOP) (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_937;
Neoadjuvant treatment with a SERD can render ER and PR low or absent at the time of surgical resection, which does not necessarily imply the presence of endocrine therapy resistant disease. The use of organoids and additional IHC markers (GATA3) demonstrate that receptor negativity may be an indicator of the drug hitting its target, suggesting ER signaling is still intact.
- amcenestrant (SAR439859) / Sanofi
EMBARGOED Pre-clinical study of amcenestrant and HER2-targeted therapies in HER2+/ER+ breast cancer cell line models (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_913;
- amcenestrant (SAR439859) / Sanofi, Verzenio (abemaciclib) / Eli Lilly
Early MRI and PET biomarkers for hormone receptor-positive/HER2-negative early-stage breast cancer in the setting of neoadjuvant endocrine therapy and neoadjuvant chemotherapy in the I-SPY 2 TRIAL (Hemisfair Ballroom) - Oct 10, 2022 - Abstract #SABCS2022SABCS_285;
Radiology 263:663–672, 2012 3. Radiology 279:44–55, 2016
- Impact of ESR1 mutations on selective estrogen receptor degraders and modulators: An integrated liquid-biopsy and pharmacodynamics approach (Stars at Night Ballroom 3&4) - Oct 10, 2022 - Abstract #SABCS2022SABCS_236;
The study suggests that genomic variability in drug targets detectable through ctDNA may modulate therapeutic response. Preclinical models are under development to investigate the combined endocrine resistance mechanism suggested by the significant co- occurrence between ESR1 mutations in SERDs/SERMs docking sites and ESR1 hotspot mutations and provide valuable additional insights for drug development and future treatment algorithms.
- ||||| amcenestrant (SAR439859) / Sanofi
Clinical: Dr. Sara Tolaney [@stolaney1] sits down with @OBRtweets to discuss the AMEERA-3 trial, which explored the selective estrogen receptor degrader (SERD) amcenestrant in patients with endocrine-resistant ER+/HER2- advanced breast cancer. #bcsm @DanaFarberNews (Twitter) - Sep 25, 2022
- |||| amcenestrant (SAR439859) / Sanofi
Clinical: The AMEERA-3 trial failed to meet its primary end point of superior progression-free survival for #amcenestrant compared with endocrine therapy in patients with endocrine-resistant, ER-positive advanced breast cancer. #bcsm #esmo22 | @stolaney1 https://t.co/vUBWcqlybb (Twitter) - Sep 22, 2022
- ||| amcenestrant (SAR439859) / Sanofi
Trial completion date, Metastases: AMEERA-5: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (clinicaltrials.gov) - Sep 22, 2022
P3, N=1068, Active, not recruiting, Sponsor: Sanofi
Preclinical models are under development to investigate the combined endocrine resistance mechanism suggested by the significant co- occurrence between ESR1 mutations in SERDs/SERMs docking sites and ESR1 hotspot mutations and provide valuable additional insights for drug development and future treatment algorithms. Trial completion date: Jun 2027 --> Dec 2023
- || amcenestrant (SAR439859) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: AMEERA-1: Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (clinicaltrials.gov) - Sep 22, 2022
P1/2, N=136, Active, not recruiting, Sponsor: Sanofi
Trial completion date: Jun 2027 --> Dec 2023 Trial completion date: Aug 2024 --> Dec 2023 | Trial primary completion date: Aug 2024 --> Dec 2023
- || amcenestrant (SAR439859) / Sanofi
Any interesting insights from ameera-3 that amcenestrant failed? (Twitter) - Sep 16, 2022
- |||| amcenestrant (SAR439859) / Sanofi
Clinical, Interview: In this @touchONCOLOGY interview, @stolaney1 discusses the phase II study, investigating amcenestrant vs endocrine treatment of physician’s choice in patients with endocrine-resistant ER+/HER2− advanced #BreastCancer. https://t.co/FBdGFuL35S (Twitter) - Sep 15, 2022
- ||| amcenestrant (SAR439859) / Sanofi
Trial completion date, Trial termination, Trial primary completion date: Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function (clinicaltrials.gov) - Sep 14, 2022
P1, N=13, Terminated, Sponsor: Sanofi
Trial completion date: Aug 2024 --> Dec 2023 | Trial primary completion date: Aug 2024 --> Dec 2023 Trial completion date: Nov 2022 --> May 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2022 --> May 2022; Sponsor decision to prematurely stop the study, not linked to any safety concern
- ||||| amcenestrant (SAR439859) / Sanofi
Clinical: The #OncoAlertTopTweet 🚨 Day 2⃣ #ESMO22 Tweet @matteolambe 🇮🇹 Presented by @stolaney1 from @DanaFarber data from #AMEERA3 trial showing no benefit of #SERD #amcenestrant 🆚standard ET in pretreated patients with advanced HR+/HER2- #BreastCancer Best, @weoncologists (Twitter) - Sep 10, 2022
- ||| amcenestrant (SAR439859) / Sanofi, giredestrant (GDC-9545) / Roche
The #OncoAlertTopTweet 🚨 Day 2⃣ #ESMO22 Tweet @hoperugo 🇺🇸 Oral SERDs @stolaney1 & miguel Martin present late line Ameera 3 and acelERA trials. Both amcenestrant and giredestrant were not better that ET of Choice but +signal in ESR1 mutant disease. Best, @weoncologists (Twitter) - Sep 10, 2022
- ||||| amcenestrant (SAR439859) / Sanofi
Clinical: (2/2) Given to the outcome of an interim analysis of ph 3 AMEERA-5 trial, Sanofi is discontinuing the global clinical development of amcenestrant. @stolaney1 #ESMO22 @myESMO (Twitter) - Sep 10, 2022
- ||||| amcenestrant (SAR439859) / Sanofi
Clinical: (1/2) Great talk by @stolaney1 sharing data of AMEERA-3 trial which did not meet its primary objective; PFS was numerically similar between amcenestrant and treatment of physician’s choice (median 3.6 vs 3.7 months; HR1.05) in pts with endocrine-resistant ER+/HER2− ABC. #ESMO22 (Twitter) - Sep 10, 2022
- |||||| amcenestrant (SAR439859) / Sanofi
Clinical: Presented by super @stolaney1 from @DanaFarber data from #AMEERA3 trial showing no benefit of #SERD #amcenestrant vs. standard endocrine therapy in pretreated patients with advanced HR+/HER2- #BreastCancer: development of this agent has been stopped #ESMO22 @OncoAlert #bcsm (Twitter) - Sep 10, 2022
- ||| amcenestrant (SAR439859) / Sanofi, giredestrant (GDC-9545) / Roche
Oral SERDs #ESMO2022 @stolaney1 and miguel Martin present late line Ameera 3 and acelERA trials. Both amcenestrant and giredestrant were not better that ET of Choice but +signal in ESR1 mutant disease. Selection/biology key in late line studies. @OncoAlert (Twitter) - Sep 10, 2022
- ||||| amcenestrant (SAR439859) / Sanofi
Clinical: Dr. Tolaney (@stolaney1) presents the results of AMEERA-3 phase 2 trial, testing amcenestrant vs endocrine treatment of physician choice in patients with HR+ metastatic breast cancer. #ESMO22 #bcsm @DFCI_BreastOnc https://t.co/RA0NQNWb60 (Twitter) - Sep 10, 2022
- ||| amcenestrant (SAR439859) / Sanofi, giredestrant (GDC-9545) / Roche, elacestrant (RAD1901) / Menarini
#Esmo22 Sanofi and Roche’s duelling #Serd duds (Via @JacobPlieth) $SNY $RHHBY #amcenestrant #giredestrant #elacestrant $RDUS #Menarini https://t.co/vtCQvv02W1 (Twitter) - Sep 7, 2022
- |||| amcenestrant (SAR439859) / Sanofi
Trial primary completion date, Metastases: AMEERA-5: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (clinicaltrials.gov) - Sep 7, 2022
P3, N=1068, Active, not recruiting, Sponsor: Sanofi
Trial completion date: Nov 2022 --> May 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2022 --> May 2022; Sponsor decision to prematurely stop the study, not linked to any safety concern Trial primary completion date: Jan 2024 --> Jun 2022
- ||||| amcenestrant (SAR439859) / Sanofi
Enrollment closed, Enrollment change: AMEERA-6: Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity (clinicaltrials.gov) - Aug 22, 2022
P3, N=3, Active, not recruiting, Sponsor: Sanofi
Trial primary completion date: Jan 2024 --> Jun 2022 Recruiting --> Active, not recruiting | N=3738 --> 3
- || amcenestrant (SAR439859) / Sanofi
Enrollment closed, Enrollment change: Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function (clinicaltrials.gov) - Aug 19, 2022
P1, N=13, Active, not recruiting, Sponsor: Sanofi
Recruiting --> Active, not recruiting | N=3738 --> 3 Recruiting --> Active, not recruiting | N=24 --> 13
- ||| amcenestrant (SAR439859) / Sanofi
Enrollment closed, Enrollment change, Combination therapy, Monotherapy, Metastases: AMEERA-1: Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (clinicaltrials.gov) - Aug 19, 2022
P1/2, N=136, Active, not recruiting, Sponsor: Sanofi
Recruiting --> Active, not recruiting | N=24 --> 13 Recruiting --> Active, not recruiting | N=251 --> 136
- |||| amcenestrant (SAR439859) / Sanofi
Sanofi trial failure halts work on breast cancer treatment amcenestrant https://t.co/vInNr8ks65 (Twitter) - Aug 17, 2022
- ||| amcenestrant (SAR439859) / Sanofi
Clinical: Sad to hear that amcenestrant program will be discontinued. We have a challenge in selecting who the right patients are for SERD, but I still believe in the SERDs and see a huge need for novel endocrine therapies. https://t.co/aXbHBX00Qy (Twitter) - Aug 17, 2022
- |||| amcenestrant (SAR439859) / Sanofi
Disappointed to see this press release that Sanofi will discontinue amcenestrant development since AMEERA-5 (amcenestrant +palbo vs AI +palbo) did not meet the prespecified boundary to continue. @OncoAlert #bcsm https://t.co/CmGevoUdBu (Twitter) - Aug 17, 2022