Delving into the Latest Updates on Tusamitamab ravtansine with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Maytansin-loaded anti-CEACAM5 mAb, Tusamitamab ravtansine, BGA 7650

+ [6]

Target

CEACAM5 x Tubulin

Action

antagonists, inhibitors

Mechanism

CEACAM5 antagonists(Carcinoembryonic antigen related cell adhesion molecule 5 antagonists), Tubulin inhibitors

Therapeutic Areas

NeoplasmsRespiratory DiseasesDigestive System Disorders+ [1]

Active Indication

CEACAM5 positive non-squamous non-small cell lung cancermetastatic non-small cell lung cancerMetastatic Non-Squamous Non-Small Cell Lung Carcinoma+ [6]

Inactive Indication

Advanced Malignant Solid NeoplasmColorectal CancerHR-positive/HER2-low Solid Tumors+ [6]

Originator Organization

ImmunoGen, Inc.

Active Organization

SanofiSanofi-Aventis Recherche & Développement SA

Innovent Biologics, Inc.

+ [1]

Inactive Organization

Sanofi SA

Innovent Biologics (Suzhou) Co. Ltd.

License Organization

ImmunoGen, Inc.

Innovent Biologics, Inc.

Sanofi

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

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Sequence Code 9561035H

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Sequence Code 9561041L

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This study is a prospective, open-label, multi-cohort, exploratory phase II clinical trial in patients with either CEACAM5-positive NSQ NSCLC, ER+ breast cancer or gastric cancer. Eligible subjects will receive Tusamitamab ravtansine (100mg/m2 IV Q2W). The investigators hypothesize that intratumoral exposure of Tusamitamab ravtansine would be an important factor in determining treatment efficacy. Combining exposure with measurements of tumor PD reactions in a proper PK/PD study is the goal of this study.

Start Date16 Feb 2024

Sponsor / Collaborator

Erasmus MC

[+1]

NCT05849246

/ TerminatedPhase 2

Open-label, Phase 2 Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)

Primary objective：
·To assess the antitumor activity of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
Secondary objectives： To assess the safety and tolerability of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
To assess the pharmacokinetic (PK) characteristic of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.

Start Date31 Jul 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT05429762

/ TerminatedPhase 1

Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

Start Date03 Oct 2022

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Tusamitamab ravtansine

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100 Translational Medicine associated with Tusamitamab ravtansine

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100 Patents (Medical) associated with Tusamitamab ravtansine

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23

Literatures (Medical) associated with Tusamitamab ravtansine

01 Feb 2026·JTO clinical and research reports

The Landscape of CEACAM5 Expression by Immunohistochemistry in NSCLC

Article

Author: Hueniken, Katrina ; Li, Quan ; Bates, Mackenzie ; Tsao, Ming-Sound ; Almutrafi, Amna ; Hou, Likun ; Pham, Nhu-An ; Azaizeh, Alhareth ; Hsu, Ying-Han R

Introduction:

Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) is a target of antibody-drug conjugate therapy for NSCLC. High expression of CEACAM5 has been reported in approximately 25% of patients with lung adenocarcinoma. However, CEACAM5 expression has not been systematically examined in a real-world and large patient population with NSCLC. There are also limited data on the prognostic impact of CEACAM5 protein expression.

Methods:

We assessed CEACAM5 protein expression by immunohistochemistry in two separate cohorts of patients with NSCLC to include both routine clinical biopsy and resection specimens, using the anti-CEACAM5 clone 769 antibody assay protocol and scoring scheme for the tusamitamab ravtansine clinical trials. Expression levels were categorized as high (≥50% tumor cells at ≥2+ intensity), moderate (1%-49% tumor cells at ≥2+ intensity), and negative (0/1+ intensity) and scored independently by three thoracic pathologists. Interrater reliability was determined by Kendall's coefficient of concordance and Fleiss' kappa. Association with PD-L1 and driver mutation was calculated by Fisher exact or chi-square test. Correlation with recurrence-free survival and overall survival was determined by log-rank tests.

Results:

The interrater reliability of CEACAM5 assessment was moderate among three pathologists. The overall prevalence of high CEACAM5 expression was 18%. CEACAM5 expression did not significantly correlate with tumor stage, PD-L1 expression, tumor mutation burden, and EGFR or KRAS mutations. There was no prognostic effect of CEACAM5 expression on recurrence-free survival or overall survival.

Conclusions:

Our data revealed that 18% of routinely diagnosed clinical NSCLC samples had high CEACAM5 expression by immunohistochemistry, and its expression was not associated with oncogenic driver mutations or patient prognosis in a predominantly early stage NSCLC cohort.

01 Feb 2026·CPT-Pharmacometrics & Systems Pharmacology

Novel Drug‐Disease Modeling Framework for Oncology Benefit–Risk Evaluation: Application to Tusamitamab Ravtansine

Article

Author: Thai, Hoai‐Thu ; Pouzin, Clemence ; Cerou, Marc ; Fliscounakis‐Huynh, Sophie ; Comets, Emmanuelle ; Chadjaa, Mustapha ; Veyrat‐Follet, Christine ; Fagniez, Nathalie ; Mihaljevic, Frano

ABSTRACT:

This study introduces a novel drug‐disease modeling framework designed to assess the benefit–risk balance of antibody‐drug conjugates (ADC) in oncology. The framework integrates dose levels, pharmacokinetics, tumor growth dynamics, progression‐free survival (PFS), and dose‐adjusted adverse events. We demonstrated this through its application to tusamitamab ravtansine (Tusa), an ADC targeting Carcinoembryonic Antigen‐Related Cell Adhesion Molecule 5 in non‐squamous non‐small cell lung cancer (nsq NSCLC). We developed our model using phase I trial safety data from 254 patients (doses: 5–190 mg/m 2 ) and efficacy data from 88 nsq NSCLC patients (dose 100 mg/m 2 ). This model accurately predicted phase III outcomes for the Tusa arm via an iterative simulation. Using phase III baseline characteristics, simulations of Tusa doses comparing three dose levels (80, 100, and 120 mg/m 2 every 2 weeks) revealed a critical trade‐off: while higher doses increased response rates, they also substantially increased corneal toxicity without improving survival. These findings demonstrate how early‐phase data can inform optimal dose selection by quantifying benefit–risk. This robust framework and methodology is generalizable beyond Tusa, offering value to support dose selection and trial decision‐making in oncology drug development.

01 Aug 2025·International Journal of Clinical Oncology

Phase 1 study evaluating safety and pharmacokinetics of tusamitamab ravtansine monotherapy in Japanese patients with advanced malignant solid tumors

Article

Author: Yamazaki, Kentaro ; Tada, Keisuke ; Ohshima, Shinobu ; Fagniez, Nathalie ; Kawakami, Takeshi ; Kadowaki, Shigenori ; Muro, Kei ; Yoshino, Takayuki ; Mishima, Saori ; Tanaka, Tomoyuki

Abstract:

Background:

Tusamitamab ravtansine (SAR408701) is an immunoconjugate that binds carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and delivers its cytotoxic payload to target cells. Here, we report findings from three dosing regimens of tusamitamab ravtansine administration in Japanese adults with advanced malignant solid tumors.

Methods:

Japanese adults (aged ≥ 20 years) with CEACAM5-expressing malignant solid tumors were enrolled in this Phase 1, open-label, non-randomized, dose-escalation evaluation of tusamitamab ravtansine in three parts: (i) main dose-escalation part with every two weeks (Q2W) administration, (ii) loading dose (LD) part with Q2W administration with a LD at Cycle 1 (C1) only, and (iii) dose-escalation every three weeks (Q3W) part. Primary objectives were to evaluate the tolerability and safety of tusamitamab ravtansine.

Results:

Nine patients were enrolled in the main dose-escalation part, 16 patients in the dose-escalation bis part with LD, and nine patients in the dose-escalation Q3W part. Administration of tusamitamab ravtansine resulted in a manageable safety profile with no dose-limiting toxicities reported during the observation period except for two events during dose-escalation bis Q2W part. Most common adverse events (AEs) were corneal events, gastrointestinal disorders, and metabolic events. After first administration, tusamitamab ravtansine exposure was dose proportional over the dose range 80–170 mg/m2. Best overall response (BOR) was stable disease, observed in all three parts; confirmed response was not observed at any dose level.

Conclusion:

Tusamitamab ravtansine demonstrated a tolerable safety profile at a dose of 80–170 mg/m2 in three different administration schedules in Japanese adults with metastatic solid tumors.

23

News (Medical) associated with Tusamitamab ravtansine

13 Sep 2024

·www.drugs.com

Tusamitamab Ravtansine Does Not Extend Survival With Nonsquamous NSCLC

FRIDAY, Sept. 13, 2024 -- Tusamitamab ravtansine (tusa rav), an immunoconjugate, does not improve progression-free survival (PFS) in patients with previously treated advanced nonsquamous non-small cell lung cancer (NSCLC), according to a study presented at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer, held from Sept. 7 to 10 in San Diego. Benjamin Besse, from Gustave Roussy in Paris, and colleagues randomly assigned adult participants in the CARMEN-LC03 trial (with previously treated advanced nonsquamous NSCLC with platinum-based chemotherapy and immunotherapy) to intravenously receive either tusa rav 100 mg/m 2 once every two weeks (194 patients) or docetaxel 75 mg/m 2 once every three weeks (177 patients). The analysis included comparison of survival among patients with CEACAM5 positivity (assessed by immunohistochemistry) of ≥2+ intensity involving ≥50 percent of tumor cells. The researchers reported that during a median follow-up of 7.4 and 18.1 months for PFS (determined by an independent radiologic committee) and overall survival (OS), respectively, median PFS for tusa rav versus docetaxel was 5.4 versus 5.9 months (hazard ratio [HR], 1.14; 95 percent confidence interval [CI], 0.86 to 1.51; P = 0.820), while median OS (60 percent information fraction) was 12.8 versus 11.5 months (HR, 0.85; 95 percent CI, 0.64 to 1.11; P = 0.112). Objective response rates were also similar between the groups. With tusa rav, time to deterioration of disease-related symptoms/physical functioning/role functioning were numerically prolonged. Tusa rav was associated with lower numbers of grade ≥3 treatment-related adverse events (AE) and treatment-related serious AEs, as well as resulting discontinuation and dose reduction. However, dose delay was more frequent with tusa rav, mainly due to corneal events. Tusa rav was associated with incidence and severity of ocular AEs that were consistent with previous studies. “Despite trends favoring tusa rav on interim OS and electronic patient-reported outcomes analysis, the study did not meet the dual primary end point on improving the PFS per central review, likely due to unanticipated higher median PFS and OS with docetaxel,” the authors write. Abstract More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultImmunotherapyClinical StudyAACR

21 Dec 2023

·firstwordpharma.com

Sanofi’s pipeline aspirations take a hit with ADC failure

Sanofi is ending development of tusamitamab ravtansine after the antibody-drug conjugate (ADC) failed to meet the primary endpoint of a Phase III study for lung cancer. The news deals an early setback to R&D head Houman Ashrafian, who only took over the role in September, as well as the company’s ambitions in oncology.The CARMEN-LC03 trial enrolled patients with metastatic non-squamous non-small-cell lung cancer whose tumours express high levels of CEACAM5, the target of tusamitamab ravtansine. Sanofi said Thursday that an independent data monitoring committee found that the study missed its dual primary endpoint of improving progression-free survival versus docetaxel.The drugmaker added that although there was a trend for improved overall survival - the trial’s other dual primary goal - the study was terminated based on non-improvement in PFS at the final analysis. Chief medical officer Dietmar Berger remarked “although the results are not what we hoped for… We will continue to explore the potential of CEACAM5 as a biomarker in cancer types where it is highly expressed,” with the company adding that it will also continue work on antibody tusamitamab-based ADCs.Tusamitamab ravtansine, also known as SAR408701, was developed through a partnership with ImmunoGen, although Sanofi was granted an exclusive license to the ADC in 2017. According to the French company’s pipeline, tusamitamab ravtansine was also being investigated in Phase II studies, both as a monotherapy and as part of combination regimens, in gastric cancer and earlier stages of lung cancer.

Phase 2License out/inADCPhase 3Phase 1

21 Dec 2023

·www.biospace.com

Sanofi Axes Lung Cancer ADC After Phase III Trial Failure

Pictured: Sanofi's Germany office at night/iStock, Panama7 Sanofi is putting the kibosh on developing its antibody-drug conjugate tusamitamab ravtansine after an analysis of a Phase III readout showed it did not meet a primary endpoint in non-small cell lung cancer, according to the company’s announcement on Thursday. The Phase III CARMEN-LC03 trial evaluated the antibody-drug conjugate (ADC) in a monotherapy setting against the chemotherapy docetaxel in non-small cell lung cancer (NSCLC) patients with tumors that had high levels of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). An independent data monitoring committee analysis found that the ADC did not reach its dual primary endpoint of progression-free survival (PFS). Despite an “improved” overall survival trend, Sanofi said it is terminating the program due to the “non-improvement” in PFS. The trial participants can stay on the therapy if benefit is seen or switch to another treatment, according to the company. However, Sanofi is not giving up on the drug as it plans to continue to “explore” the potential of tusamitamab-based ADCs and CEACAM5 research in other cancers. “Although the results are not what we hoped for, our research and work to advance potentially transformative therapies in areas of high unmet need for people living with cancer will not stop. We will continue to explore the potential of CEACAM5 as a biomarker in cancer types where it is highly expressed,” Sanofi CMO Dietmar Berger said in a statement. The ADC was looking encouraging, according to a document from ASCO related to the ADC’s safety which found the adverse effects of tusamitamab ravtansine were “nonserious and reversible.” Sanofi licensed the rights to the ADC outside of China from Innovent in 2017 and expanded the agreement in 2022 to nab the rights in China and grab another one of Innovent’s assets, according to Pharmaphorum. Sanofi has been playing in the ADC space for a number of years, as it has been inking collaboration deals since at least 2015. Last year, the French pharma secured an exclusive agreement with Seagen to develop and commercialize ADCs for cancer treatments. The deal had Sanofi and Seagen co-funding the development activities for up to three cancer targets, with the companies splitting the profit. Sanofi also paid Seagen an unknown amount for the three targets. Sanofi’s decision to discontinue the global clinical development program for tusamitamab ravtansine comes amid some high-pro in the ADC space by prominent pharma players including Pfizer, BMS, AbbVie and AstraZeneca. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Phase 3ADCLicense out/in

100 Deals associated with Tusamitamab ravtansine

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	United States	Sanofi	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	China	Sanofi SA	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	China	Sanofi	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	Japan	Sanofi SA	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	Japan	Sanofi	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	Argentina	Sanofi	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	Argentina	Sanofi SA	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	Australia	Sanofi SA	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	Australia	Sanofi	06 Feb 2020
CEACAM5 positive non-squamous non-small cell lung cancer	Phase 3	Belgium	Sanofi	06 Feb 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02187848 (Pubmed \| Transl Oncol)	Phase 1	Advanced Lung Non-Small Cell Carcinoma CEACAM5	92	Tusamitamab ravtansine 100 mg/m2 (High CEACAM5 expression)	ngdunyvwka(hcphwszmlv) = hcwmcfbuyq ddwawcdibq (yiihcgqaoz ) View more	Positive	01 Jan 2026
				Tusamitamab ravtansine 100 mg/m2 (Moderate CEACAM5 expression)	ngdunyvwka(hcphwszmlv) = kpsfxprrbp ddwawcdibq (yiihcgqaoz ) View more
NCT05245071 (CARMEN-LC06, ESMO_ELCC2025) Manual	Phase 2	Non-squamous non-small cell lung cancer	22	Tusamitamab ravtansine 100 mg/m²	aknrzrbxve(fqetqqayaq) = dnljqufzhz beroqwtjtd (xotlolyfso, 1.1 - 29.2) View more	Negative	26 Mar 2025
NCT05245071 (CARMEN-LC06, CTgov)	Phase 2	Non-squamous non-small cell lung cancer	22	Ravtansine+Tusamitamab	lncjhwoyqq = mqbdjsczut tsggxowati (cmjcmvwiln, xbfnpzhjbq - bocivwklvj) View more	-	25 Mar 2025
NCT04659603 (CARMEN-BT01, CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic \| Advanced Malignant Solid Neoplasm \| Metastatic breast cancer	50	tusamitamab ravtansine (Cohort A: mBC)	mybkkipfqh = crmwasvcmv jphssagixz (alrerdddzi, oamoxreecu - tstxrrllrj) View more	-	25 Mar 2025
				tusamitamab ravtansine (Cohort B: mPAC)	mybkkipfqh = hublybtbgu jphssagixz (alrerdddzi, ymhtlxdagr - pcgfpvrxfi) View more
NCT04524689 (CARMEN-LC05, CTgov)	Phase 2	Non-squamous non-small cell lung cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	57	Ravtansine+Tusamitamab+Pembrolizumab (Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab)	kxoqzlxcjv = uaxtyhlcdm wvovvivubz (bmhojusvna, tsqrtmnmsr - silojhzpiv) View more	-	17 Mar 2025
				Ravtansine+Tusamitamab+Pembrolizumab (Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab)	kxoqzlxcjv = aqjywigqec wvovvivubz (bmhojusvna, hrtvrquixy - hsocaophzm) View more
NCT05071053 (CARMEN-GC01, CTgov)	Phase 2	stomach adenocarcinoma \| Gastrooesophageal junction cancer \| Gastroesophageal junction adenocarcinoma	35	Ravtansine+Tusamitamab+Ramucirumab	kifsfnvibm = lhhoswezet wghlvgpcbc (kpcdbazwll, kcyauvmkkb - fcabbrvcxk) View more	-	05 Dec 2024
NCT04154956 (CARMEN-LC03, CTgov)	Phase 3	CEACAM5 positive non-squamous non-small cell lung cancer \| metastatic non-small cell lung cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	389	Docetaxel	tpubkgimud(dsxjqtxikz) = kxzzcvbfev lieavuxxnl (ijoofsbpps, yznhtyxmtu - ssgatfsaqh) View more	-	01 Nov 2024
NCT04524689 (CARMEN-LC05, ESMO2024) Manual	Phase 2	Non-squamous non-small cell lung cancer CEACAM5 Positive	57	Tusamitamab ravtansine + PembrolizuPembrolizumab	gbthbgngtx(lynlrzkeur) = cubfvdfaho okxdjmbvgv (gbdhfgvikq ) View more	Positive	14 Sep 2024
				Tusamitamab ravtansine 170 mg/m^2+ Pembrolizumab	gbthbgngtx(lynlrzkeur) = kzgpghkfen okxdjmbvgv (gbdhfgvikq ) View more
NCT04394624 (CARMEN-LC04, CTgov)	Phase 2	metastatic non-small cell lung cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	31	Ravtansine+Tusamitamab+Ramucirumab (Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab)	txxwsgunuu = zkelhvpglo glyanppnzz (vznaqzllth, llsabhlrwi - mgeopabcpo) View more	-	28 Mar 2024
				Ravtansine+Tusamitamab+Pembrolizumab+Ramucirumab (Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab)	fedccrwnli(ettzynniip) = iddkwapzbh ypaujdgoak (krpxkpvftp, vlkpoyambq - rnevftludj) View more
NCT04154956 (CARMEN-LC03, Corporate Publications) Manual	Phase 3	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma Second line	-	tusamitamab ravtansine	pyzmvphipr(ocmvpsjmdq) = did not meet qrqogpgqpz (yypsdmuupz ) Not Met View more	Negative	21 Dec 2023
				docetaxel

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