A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors

Multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT)

开始日期2021-12-21

申办/合作机构

Orano Med LLC

[+1]

NCT03466216

/ Terminated临床1期

A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of AlphaMedix™ in Adult Subjects With SSRT(+) NETs.

AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications.
This drug addresses an unmet need in the field of peptide receptor radionuclide therapy (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumor cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug.

开始日期2018-02-05

申办/合作机构

Orano Med LLC

100 项与 212Pb-AR-RMX 相关的临床结果

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100 项与 212Pb-AR-RMX 相关的转化医学

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100 项与 212Pb-AR-RMX 相关的专利（医药）

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项与 212Pb-AR-RMX 相关的文献（医药）

2025-12-01·APPLIED RADIATION AND ISOTOPES

Activity standardization and determination of nuclear decay data of 212Pb at LNE-LNHB and first measurements in the SIR at BIPM

Article

作者: Chambon, L ; Michotte, C ; Coulon, R ; Loidl, M ; Amiot, M-N ; Carceller, C ; Bobin, C ; Sabot, B ; Thiam, C ; Pierre, S ; Boyer, B ; Courte, S ; Morelli, S ; Dulieu, C ; Lourenço, V

Lead-212/Bismuth-212 is a promising radiopharmaceutical with high therapeutic potential for Targeted Alpha Therapy. In this paper, the activity standardization of ²¹²Pb in equilibrium with its progeny was addressed by means of several measurement techniques at LNE-LNHB using a radioactive solution of ²¹²Pb-DOTAMTATE supplied by Orano Med (France). The primary standard was established by liquid scintillation counting using the Triple-to-Double Coincidence Ratio (TDCR) method and transferred to the Vinten 671 ionization chamber. The experimental calibration coefficients were compared to Monte Carlo simulations using the Penelope and Geant4 codes. An ampoule filled with a standardized solution of ²¹²Pb was sent to the BIPM for a submission to the International Reference System (SIR). The resulting equivalent activity was compared to the value calculated from the SIRIC software. A new measurement of the half-life of ²¹²Pb using a Centronic IG11 IC is presented. New γ-photon intensities based on γ-spectrometry were also measured. The present study on the metrological traceability of the radiopharmaceutical ²¹²Pb is an important outcome in the framework of the European project EPM AlphaMet (Metrology for Emerging Targeted Alpha Therapies).

2022-09-01·JOURNAL OF NUCLEAR MEDICINE1区 · 医学

Targeted α-Emitter Therapy with ²¹²Pb-DOTAMTATE for the Treatment of Metastatic SSTR-Expressing Neuroendocrine Tumors: First-in-Humans Dose-Escalation Clinical Trial

1区 · 医学

Article

作者: Tworowska, Izabela ; Torgue, Julien ; Delpassand, Ebrahim S ; Núñez, Rodolfo ; Hurt, Jason ; Shafie, Afshin ; Esfandiari, Rouzbeh

Peptide receptor radiotherapy with somatostatin analogs has been successfully used for years as a treatment for somatostatin-overexpressing tumors. Treatment of neuroendocrine tumors (NETs) with the β-particle emitter ¹⁷⁷Lu-DOTATATE is currently considered the standard of care for subjects with gastroenteropancreatic NETs. Despite the success of ¹⁷⁷Lu-DOTATATE, there remains significant room for improvement in terms of both safety and efficacy. Targeted α-emitter therapy with isotopes such as ²¹²Pb has the potential to improve both. Here, we present the preliminary results of the phase 1 first-in-humans dose-escalation trial evaluating ²¹²Pb-DOTAMTATE (a bifunctional metal chelator [DOTAM] and the SSTR-targeting peptide [TATE]) in patients with somatostatin receptor-positive NETs. Methods: Twenty subjects with histologically confirmed NETs, prior positive somatostatin analog scans, and no prior history of ¹⁷⁷Lu/⁹⁰Y/¹¹¹In peptide receptor radiotherapy, with different primary sites of the disease, were enrolled. Treatment began with single ascending doses of ²¹²Pb-DOTAMTATE, with subsequent cohorts receiving an incremental 30% dose increase, which was continued until a tumor response or a dose-limiting toxicity was observed. This was followed by a multiple ascending dose regimen. The recommended phase 2 dose regimen consisted of 4 cycles of 2.50 MBq/kg (67.6 μCi/kg) of ²¹²Pb-DOTAMTATE administered at 8-wk intervals, intravenously. Results: Ten subjects received the highest dose, 2.50 MBq/kg/cycle (67.6 μCi/kg/cycle). Treatment was well tolerated, with the most common treatment-emergent adverse events being nausea, fatigue, and alopecia. No serious treatment-emergent adverse events were related to the study drug, and no subjects required treatment delay or a dose reduction. An objective radiologic response of 80% was observed for the first 10 subjects treated at the recommended phase 2 dose. Conclusion: Targeted α-therapy with ²¹²Pb-DOTAMTATE has been shown to be well tolerated. Preliminary efficacy results are highly promising. If these results are confirmed in a larger, multicenter clinical trial, ²¹²Pb-DOTAMTATE would provide a substantial benefit over currently Food and Drug Administration-approved therapies for patients with metastatic or inoperable SSTR-expressing NETs regardless of the grade and location of the primary tumor.

2019-05-01·MOLECULAR CANCER THERAPEUTICS

Preclinical Investigation of 212Pb-DOTAMTATE for Peptide Receptor Radionuclide Therapy in a Neuroendocrine Tumor Model

Article

作者: Torgue, Julien J. ; Tworowska, Izabela ; Stallons, Tania A. Rozgaja ; Saidi, Amal ; Delpassand, Ebrahim S.

Abstract:

Somatostatin analogues have been examined as a treatment for somatostatin receptor overexpressing tumors for years; specifically, octreotate (TATE) and octreotide (TOC). Several versions of these analogues coupled to beta or gamma nuclides are currently used as imaging agents, as treatments with peptide receptor radionuclide therapy (PRRT) for patients with neuroendocrine tumors or are being explored in preclinical and clinical settings. Our study describes the use of 212Pb-DOTAMTATE, the octreotate analogue, in combination with 212Pb, the parent of an alpha emitter. Preclinical studies demonstrated tumor targeting of 212Pb-DOTAMTATE of >20% ID/g up to 24 hours post drug injection. The addition of kidney protection agents, including l-lysine and l-arginine decreases drug accumulation in the kidneys and the addition of ascorbic acid to the chelation mixture reduces oxidation of the drug product. 212Pb-DOTAMTATE displays a favorable toxicity profile with single-dose injections of 20 μCi showing 100% survival and with nontoxic cumulative doses up to 45 μCi, when fractionated into three smaller doses of 15 μCi. In an initial efficacy study, a single 10 μCi injection of 212Pb-DOTAMTATE extended the mean survival 2.4-fold. Efficacy was enhanced by giving three treatment cycles of 212Pb-DOTAMTATE and reducing the time between injections to two weeks. Efficacy was optimized further by the addition of a chemo-sensitizing agent, 5-fluorouracil, given in combination with three cycles of 10 μCi 212Pb-DOTAMTATE. These conditions led to 79% of the animals being tumor free at the end of the 31-week study suggesting that 212Pb-DOTAMTATE alone or in combination with a chemotherapeutic may have positive clinical implications.

项与 212Pb-AR-RMX 相关的新闻（医药）

2025-10-20

·GlobeNewswire-Health Care

Press Release: ESMO: AlphaMedixTM phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors

ESMO: AlphaMedixTM phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors New AlphaMedix data showed sustained and clinically meaningful responses across both RLT-naïve and RLT-exposed patients with unresectable or metastatic GEP-NETs First phase 2 study to evaluate TAT with lead-212 supporting its potential to address high unmet medical needs in difficult-to-treat, rare cancersPhase 2 study met all primary efficacy endpoints and was presented across two oral presentations at the 2025 ESMO Congress in Berlin, Germany Paris, October 20, 2025. New data from the ALPHAMEDIX-02 phase 2 study (clinical study identifier: NCT05153772) evaluating AlphaMedix (212Pb-DOTAMTATE), an investigational somatostatin receptor (SSTR) targeted alpha therapy (TAT) using the lead-212 isotope, underscore the first-in-class potential of this investigational medicine for the treatment of patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Detailed results from the phase 2 study, the first to evaluate a TAT across both radioligand therapy (RLT)-naïve and RLT-exposed patients affected by GEP-NETs, were presented in two oral presentations at the 2025 European Society for Medical Oncology (ESMO) Congress, Berlin, Germany. “Lead-212-based Targeted Alpha Therapy (TAT) could have a transformative impact across a broad range of solid tumors. With AlphaMedix’s consistent and clinically meaningful responses across both RLT-naïve and RLT-exposed gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients, the positive results underscore its potential in this rare and difficult-to-treat cancer,” said Volker Wagner, MD, PhD, Chief Medical Officer at Orano Med. “These data strongly encourage us to further advance the clinical development of AlphaMedix, and jointly with our partner, Sanofi, make this innovative TAT available to patients in need.” ALPHAMEDIX-02 phase 2 study ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix in patients with unresectable or metastatic SSTR+ GEP-NETs. The study included two cohorts evaluating RLT-naïve and RLT-exposed patients. The primary efficacy endpoint across both cohorts was the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS) and overall survival (OS). The study's efficacy endpoints are based on local investigator assessment, per protocol. In addition, a blinded independent central review (BICR) was conducted subsequently. The key efficacy endpoints were met within both the investigator-assessed and BICR results. The following results were presented: RLT-Naïve(n=35) Investigator assessment Independent assessment (BICR) *DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a ORR 60.0%(95% CI: 42.1-76.1) 57.1%(95% CI: 39.4-73.7) Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)* 71.9% for ≥ 24 months(95% CI: 44.6-87.4) 81.7% for ≥ 24 months(95% CI: 53.1-93.8) Complete Response (CR) - 2.9% Partial Response (PR) 60.0% 54.3% Stable Disease (SD) 34.3% 28.6% Disease control rate (DCR)** 94.3% (95% CI: 80.8-99.3) 85.7% (95% CI: 69.7-95.2) PFS 36-month PFS rate of 72.3% (95% CI: 53.3-84.5) 36-month PFS rate of 63.3% (95% CI: 40.3-79.4) OS 36-month OS rate of 88.2% (95% CI: 71.5-95.4) Not applicable*** RLT-Exposed(n=26) Investigator assessment Independent assessment (BICR) *DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a ORR 34.6%(95% CI: 17.2-55.7) 19.2%(95% CI: 6.6-39.4) Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)* 100% for ≥ 18 months(95% CI: 100-100) 100% for ≥ 18 months(95% CI: 100-100) Partial Response (PR) 34.6% 19.2% Stable Disease (SD) 61.5% 80.8% Disease control rate (DCR)** 96.2%(95% CI: 80.4-99.9) 100%(95% CI: 86.8-100) PFS 18-month PFS rate of 82.6% (95% CI: 59.0-93.3) 18-month PFS rate of 88% (95% CI: 67.3-96.0) OS 18-month OS rate of 85.1% (95% CI: 58.5-95.2) Not applicable*** AlphaMedix™ had a similar safety profile across both cohorts. Within the RLT-naïve cohort, 85.7% of patients received all four doses of AlphaMedix, and 84.6% of patients within the RLT-exposed cohort. All GEP-NET patients experienced at least one treatment-emergent adverse event (TEAE). Grade ≥3 TEAEs occurred in 42.3% of RLT-exposed patients and 54.3% of RLT-naïve patients. The most common Grade ≥3 TEAEs in both groups was lymphocyte count decrease (25.7% of RLT-naïve patients and 15.4% of RLT-exposed patients). “The future of oncology research will be driven by cutting-edge science and next-generation modalities, such as radioligand therapies. AlphaMedix, a promising targeted alpha therapy, embodies the type of solution Sanofi is working to advance,” said Christopher Corsico, MD, Global Head of Development at Sanofi. “We are excited to share these robust scientific findings at ESMO as the data could represent a significant advancement in how we treat gastroenteropancreatic neuroendocrine tumors. As we engage with health authorities and advance the clinical program, we remain focused on bringing this innovative modality to patients who need new treatment options” Advancing AlphaMedix in GEP-NETsRLTs, which work by delivering radiation directly to tumor cells, represent an emerging area of oncology research. While current approved beta-emitting RLTs have improved outcomes in patients with GEP-NETs, there remains a critical gap in care, including in those who have progressed following previous RLT. TAT represents an innovative modality in RLT, harnessing high-energy, short-range alpha emissions to precisely target cancer cells while reducing potential exposure to surrounding tissue. "The results observed in the ALPHAMEDIX-02 trial clearly demonstrate exceptional levels of efficacy for a Targeted Alpha Therapy (TAT), based on current available therapies, in both radioligand therapy (RLT)-naïve and RLT-exposed populations and could potentially set new expectations when treating gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients with RLTs” said Ebrahim Delpassand, MD, Founder and Chairman, CEO of RadioMedix. “For too long, this patient population has experienced inadequate disease control with current approved therapies. This important work provides hope for a new treatment for GEP-NET patients, their caregivers, and their healthcare providers.” In February 2024, AlphaMedix™ was designated as a breakthrough therapy by the US Food and Drug Administration in RLT-naïve patients with unresectable or metastatic GEP-NETs, recognizing the potential clinical benefits of lead-212–based TATs. The ALPHAMEDIX-02 results will form the basis for further discussions with health authorities. An international phase 3 study to further evaluate AlphaMedix in GEP-NETs is actively being planned. AlphaMedix is an investigational medicine and has not been approved by any regulatory authority. In September 2024, Sanofi entered an exclusive licensing agreement with Orano Med and RadioMedix to globally commercialize AlphaMedix. About the ALPHAMEDIX-02 studyALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix (212Pb-DOTAMTATE) in patients with histologically confirmed unresectable or metastatic GEP-NETs, positive somatostatin analogue imaging and at least one site of measurable disease. The study included two cohorts evaluating RLT-naïve (n=35) and RLT-exposed (n=26) GEP-NET patients. RLT-exposed patients had progressive disease after receiving up to four doses of 177Lu-DOTATATE and received their last dose at least six months prior to Day 1. In both cohorts, AlphaMedix was administered at 67.6 μCi/kg every eight weeks for up to four cycles (6 mCi maximum per cycle). The primary efficacy endpoint across both cohorts was ORR per RECIST 1.1. Secondary endpoints included PFS and OS. About NETs NETs are a heterogeneous group of cancers that originate from neuroendocrine cells. These cancers occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as the ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors. Despite the global prevalence of NETs increasing each year, it is considered a rare cancer that is estimated to affect approximately 35/100,000 individuals worldwide. In the United States, around 12,000 patients annually are expected to be diagnosed with neuroendocrine tumors, with an average five-year survival rate of 60% at a metastatic stage. About Orano MedOrano Med is a subsidiary of the Orano Group. Orano Med is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT). Leveraging its unique and secured access to 212Pb, the company is developing several 212Pb-based radioligand therapies combined with various targeting agents. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently expanding its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe. About RadioMedixRadioMedix, Inc., a clinical-stage biotechnology company and former sponsor of the AlphaMedix trial, is based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract service facilities for academic and industrial partners. including a cGMP and analytical suite for Phase I-II-III clinical trials and commercial launch. To learn more, visit www.radiomedix.com and LinkedIn. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Orano MedRegina Jehle | +33 6 74 56 11 31 | regina.jehle@orano.group Orano Press Office | +33 (0)1 34 96 12 15| press@orano.group Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group with the exception of Orano Med and AlphaMedix™. Attachment Press_Release

临床结果临床2期临床3期引进/卖出突破性疗法

2025-10-20

·EndPoints

Sanofi, Orano Med’s radiopharmaceutical looks competitive in rare cancer

AlphaMedix, the radiopharmaceutical being developed by Sanofi and its partner Orano Med, caused tumors to shrink or disappear in 57% of patients with a rare cancer who had not received a radioligand before, according to data revealed Monday. The uncontrolled mid-stage trial, called ALPHAMEDIX-02, enrolled 61 patients with a disease known as advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The partners said on Oct. 8 that the trial had succeeded . The overall response rate with AlphaMedix compares well with data from a trial of the only radioligand approved in this tumor type, Novartis’ Lutathera. In a Phase 3 study called NETTER-1, Lutathera achieved an ORR of just 18% in radioligand-naïve patients. “That is really obviously tremendously different,” Orano Med’s CMO Volker Wagner told Endpoints News ahead of the data presentation at the annual meeting of the European Society for Medical Oncology in Berlin. Another investigational radiopharmaceutical, ITM Isotope Technologies Munich’s ITM-11, reported ORR data at ESMO. In the Phase 3 COMPETE trial in GEP-NETs, 22% of radioligand-naïve patients responded to ITM-11. In Sanofi and Orano’s trial, the cancer was no longer detectable in 2.9% of 35 patients who had not received a radiopharmaceutical before. In a further 54%, the tumors were still there but had shrunk in size. In study participants that responded, 82% remained in response after at least two years. After three years, progression-free survival was 63%. Median PFS has not yet been reached in the trial, Wagner said, but he believes that AlphaMedix could beat Lutathera on this measure too. “The median PFS reported in NETTER-1 was 26 months,” he said. “We haven’t reached that yet, but when you look at the PFS rate … at 36 months, I think that gives us reason to be optimistic.” ALPHAMEDIX-02 also included a cohort of patients whose disease had progressed despite therapy with Lutathera. In this group, 19% of subjects saw their tumors shrink, though none had their cancer completely eliminated. Also, Lutathera-exposed patients who responded to AlphaMedix were still responding 18 months later. The 18-month progression-free survival rate was 88%. The Monday results come from a blinded independent assessment of ALPHAMEDIX-02; Sanofi and Orano also provided figures calculated by the trial investigators, which tend to be more positive. Patients in the trial received up to four doses of AlphaMedix, given every two months. The endpoints were measured two years after the final dose was administered. All the trial subjects had at least one treatment-emergent adverse event. Grade 3 or worse TEAEs occurred in 42% of Lutathera-exposed patients and 54% of radioligand-naïve patients. The most common grade 3 or worse TEAEs was lymphocyte count decrease, seen in 26% of radioligand-naïve patients and 15% of those who had failed on Lutathera. Sanofi and Orano Med plan to push AlphaMedix into global Phase 3 trials. Wagner declined to spell out the timing or size of such a trial, or whether it would be in patients who already had radioligand treatment. He did say that the Phase 3 would likely have a control arm. One possibility is that AlphaMedix might be pitted head-to-head against Lutathera, though Wagner did not confirm this. AlphaMedix targets the somatostatin receptor and delivers a radioactive payload of lead-212. This isotope emits alpha radiation, which the partners believe could be safer than beta emitters such as Lutathera and ITM-11.

临床结果临床3期ASCO会议

2025-10-13

·佰傲谷BioValley

1.1亿美元引进的放射性偶联物，2期所有疗效终点达到

在临床应用和开发当中，越来越多的证据表明放射性偶联物是一种有前景的药物开发类型。 2025年10月8日，赛诺菲发布了其在研放射性配体药物AlphaMedix在2期研究中达到了所有主要疗效终点，显示出对胃肠胰神经内分泌肿瘤（GEP-NET）患者具有临床意义且持久的益处。在新闻稿中，赛诺菲透露，该2期研究的成功结果将成为未来与卫生当局讨论的基础，以支持AlphaMedix的监管申请。 2期大获成功的AlphaMedix AlphaMedix（212Pb-dotamtate）是一种靶向生长激素抑制素受体（SSTR）的α粒子激发的多肽偶联核素药物。是由赛诺菲于2024年9月以最高3.2亿欧元（1亿欧元预付款和2.2亿欧元的里程碑付款）从Orano Group子公司Orano Med引进的资产。 AlphaMedix在2024年2月获得了美国FDA授予的突破性疗法资格，用于治疗未接受过多肽受体靶向放射治疗（PRRT）治疗的不可切除或转移性且SSTR阳性胃肠胰神经内分泌肿瘤（GEP-NET）患者。 AlphaMedix正在进行一项2期研究ALPHAMEDIX-02，以评估AlphaMedix在经组织学证实的不可切除或转移性且SSTR阳性，至少一个可测量疾病部位的GEP-NET的有效性和安全性；该研究分为两个队列：未曾接受过PRRT治疗（PRRT初治）（n=35）和曾接受过PRRT治疗（PRRT暴露）（n=26）。实际上简单来说就是区分为是否接受过诺华Lutathera治疗。此前，AlphaMedix曾报告，在2期研究中的在未接受过PRRT治疗的不可切除或转移性且SSTR阳性的GEP-NET患者的队列1中，客观缓解率（cORR）达到了47.2%。最近赛诺菲更新的2期结果，显示AlphaMedix在PRRT初治和PRRT暴露的不可切除或转移性且SSTR阳性的GEP-NET患者队列（队列2）中，显示出具有临床意义的总体缓解率和长期临床获益，包括无进展生存期（PFS）和总生存期（OS）。同时，AlphaMedix具有可控的安全性，2个队列的安全性相似。该研究正在进行中，完整结果将在2025年欧洲肿瘤内科学会（ESMO）大会上公布。结果也将构成与卫生当局讨论的基础。小结实际上，简单来说，AlphaMedix的2期研究中的2个队列区分主要是——是否接受过诺华Lutathera治疗。诺华的Lutathera是一款基于镥-177的肽受体放射性核素偶联物，于2018年获得FDA的批准用于SSTR阳性的GEP-NET成人患者。目前已经获得欧洲、美国、日本等多个监管机构的批准。 AlphaMedix的适应症与Lutathera一致，未来如果AlphaMedix成功上市，将会与Lutathera形成市场竞争。但不同的是，AlphaMedix是基于铅-212的α粒子。根据报道，相较于β核素，α核素在衰变过程中能够发射α粒子，其传能线密度（LET）比β核素高出近百倍，肿瘤杀灭效果优于β核素。另一方面，β核素破坏肿瘤细胞DNA单链，肿瘤细胞有修复的可能，从而导致肿瘤复发。但α核素可直接破坏肿瘤细胞DNA双链，导致肿瘤细胞永久性杀灭。此外，α粒子的射程较短，可能会减少对周围健康组织的暴露，具有更良好的安全性。参考资料： 1.https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053 2.https://www.fiercebiotech.com/biotech/sanofis-110m-radioligand-therapy-hits-response-rate-goal-phase-2-tumor-trial · · · · · · · ·

临床2期突破性疗法放射疗法引进/卖出临床结果

100 项与 212Pb-AR-RMX 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
生长抑素受体阳性神经内分泌肿瘤	临床2期	美国	Orano Med LLC	2021-12-21
神经内分泌肿瘤	临床2期	美国	RadioMedix, Inc.	2021-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05153772 (ALPHAMEDIX 02, Company_Website) 人工标引	临床2期	胃肠胰神经内分泌肿瘤 Somatostatin Receptor Positive	-	AlphaMedix (PRRT‑naïve)	鏇窪願鹽鏇膚觸膚糧網(鹹繭觸襯獵蓋構膚鬱衊) = AlphaMedix met all primary efficacy endpoints and showed clinically meaningful overall response rates. 鹹窪糧顧鏇餘簾衊願衊 (夢壓糧糧廠壓鏇鬱衊蓋 ) 达到更多	积极	2025-10-08
NCT05153772 (ALPHAMEDIX 02, Company_Website) 人工标引	临床2期	胃肠胰神经内分泌肿瘤 Somatostatin Receptor Positive	-	AlphaMedix (PRRT‑exposed)		积极	2025-10-08
NCT05153772 (ALPHAMEDIX 02, ASCO2024)	临床2期	胃肠胰神经内分泌肿瘤 SSTR+	-	212Pb-DOTAMTATE	構夢餘築遞鹹窪醖鏇鏇(艱艱網鬱觸餘簾鹹鹹鏇) = 蓋積網衊淵窪壓遞糧鏇淵鏇觸窪餘醖鑰鏇襯蓋 (憲顧觸鹹廠繭餘憲觸廠, 32.0 ~ 63.0)	积极	2024-05-24
NCT05153772 (ALPHAMEDIX 02, ASCO2024)	临床2期	胃肠胰神经内分泌肿瘤 SSTR+	-	177Lu-DOTATATE	構夢餘築遞鹹窪醖鏇鏇(艱艱網鬱觸餘簾鹹鹹鏇) = 憲蓋獵餘壓鏇鹽獵網衊淵鏇觸窪餘醖鑰鏇襯蓋 (憲顧觸鹹廠繭餘憲觸廠, 10 ~ 25)	积极	2024-05-24
212Pb-DOTAMTATE (SNMMI2022)	N/A	神经内分泌肿瘤 SSTR expressing	11	212Pb-DOTAMTATE at 67.6 µCi/kg/cycle	鹽憲鏇艱構積鏇襯淵齋(齋壓觸鬱淵積餘觸壓衊) = 網衊鹹積簾夢壓窪鏇鏇憲鹽憲鹹繭築糧憲鑰願 (顧鏇網選窪遞夢鹹蓋夢 )	积极	2022-08-08
NCT03466216 (ASCO2022) 人工标引	临床1期	神经内分泌肿瘤	10	212Pb-DOTAMTATE	糧鑰獵願齋醖鬱選糧糧(鬱選憲膚構鬱觸憲襯齋) = 壓鬱憲蓋糧艱築蓋網壓願淵製選鏇範遞顧齋餘 (窪齋鹽選鬱遞憲製獵鑰 ) 更多	积极	2022-06-02
NCT03466216 (ASCO 12021 \| ASCO 22021) 人工标引	临床1期	神经内分泌肿瘤一线 SSTR Expression	20	AlphaMedix	鹽構遞夢製選積簾憲繭(鏇淵獵憲餘夢範遞範遞) = 選襯齋鏇簾選淵鹹獵窪鑰願膚壓鏇鬱膚艱窪繭 (憲鹽淵網膚夢積構遞鹹 ) 更多	积极	2021-05-20
AlphaMedix (EANM2020)	N/A	神经内分泌肿瘤 SSTR-	16	AlphaMedix 30.7 ÂµCi/kg	遞衊窪積餘鑰選製願鏇(憲簾遞窪餘齋簾廠繭醖) = 7/16 (43%) 選壓鹹蓋製鑰窪繭壓醖 (鹽廠糧構鹽艱壓遞糧淵 ) 更多	积极	2020-09-18
AlphaMedix (EANM2020)	N/A	神经内分泌肿瘤 SSTR-	16	AlphaMedix 40.0 ÂµCi/kg		积极	2020-09-18
AACR2020	N/A	神经内分泌肿瘤	13	AlphaMedixTM	範製製鏇顧遞蓋窪醖鹹(製鹹衊艱鏇簾鬱鑰製選) = No clinically significant investigational drug-related hematological and renal toxicity was noted. 夢蓋艱製遞顧憲繭窪構 (糧顧窪鏇膚積膚鹽繭鹹 ) 更多	积极	2020-08-15