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, IBI-126

+ [3]

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+ [3]

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

Colorectal CancerHR-positive/HER2-low Solid TumorsMetastatic Gastric Carcinoma+ [4]

Originator Organization

ImmunoGen, Inc.

Active Organization

Sanofi

Innovent Biologics, Inc.Sanofi-Aventis Recherche et Développement SA

+ [1]

Inactive Organization

Sanofi SA

Sanofi-Aventis Deutschland GmbH

Innovent Biologics (Suzhou) Co. Ltd.

License Organization

ImmunoGen, Inc.

Innovent Biologics, Inc.

Sanofi SA

+ [1]

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

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Sequence Code 9561035H

Source: *****

Sequence Code 9561041L

Source: *****

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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26

Literatures (Medical) associated with Tusamitamab ravtansine

01 Feb 2024·Clinical pharmacology and therapeutics

Prediction of CYP Down Regulation after Tusamitamab Ravtansine Administration (a DM4‐Conjugate), Based on an In Vitro–In Vivo Extrapolation Approach

Article

Author: Klieber, Sylvie ; Teutonico, Donato ; Ziti-Ljajic, Samira ; Pardon, Magalie ; Nguyen, Laurent ; Pouzin, Clemence ; Perreard-Dumaine, Anne ; Fagniez, Nathalie

Tusamitamab ravtansine is an antibody‐drug conjugate (ADC) composed of a humanized monoclonal antibody (IgG1) and DM4 payload. Even if DM4 and its main metabolite methyl‐DM4 (Me‐DM4) circulate at low concentrations after ADC administration, their potential as perpetrators of cytochrome P450 mediated drug–drug interaction was assessed. In vitro studies in human hepatocytes indicated that Me‐DM4 elicited a clear concentration‐dependent down regulation of cytochrome P450 enzymes (CYP3A4, 1A2, and 2B6). Because DM4 was unstable under the incubation conditions studied, the in vitro constants could not be determined for this entity. Thus, to predict the clinical relevance of this observed downregulation, an in vitro‐in vivo extrapolation (IVIVE) pharmacokinetic (PK) based approach was developed. To mitigate model prediction errors and because of their similar inhibitory effect on tubulin polymerization, the same downregulation constants were used for DM4 and Me‐DM4. This approach describes the time course of decreasing CYP3A4, 1A2, and 2B6 enzyme amounts as a function of circulating concentrations of DM4 and Me‐DM4 predicted from a population PK model. The developed IVIVE‐PK model showed that the highest CYP abundance decrease was observed for CYP3A4, with a transient reduction of < 10% from baseline. The impact on midazolam exposure, as probe substrate of CYP3A, was then simulated based on a physiologically‐based PK static method. The maximal CYP3A4 abundance reduction was associated with a predicted midazolam area under the curve (AUC) ratio of 1.14. To conclude, the observed in vitro downregulation of CYPs by Me‐DM4 is not expected to have relevant clinical impact.

31 Dec 2023·mAbs

Antibodies to watch in 2023

Article

Author: Crescioli, Silvia ; Kaplon, Hélène ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Chenoweth, Alicia

In this 14th installment of the annual Antibodies to Watch article series, we discuss key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecast events that might occur in 2023. As of mid-November, 12 antibody therapeutics had been granted first approvals in either the United States or European Union (tebentafusp (Kimmtrak), faricimab (Vabysmo), sutimlimab (Enjaymo), relatlimab (Opdualag), tixagevimab/cilgavimab (Evusheld), mosunetuzumab (Lunsumio), teclistamab (TECVAYLI), spesolimab (SPEVIGO), tremelimumab (Imjudo; combo with durvalumab), nirsevimab (Beyfortus), mirvetuximab soravtansine (ELAHERE™), and teplizumab (TZIELD)), including 4 bispecific antibodies and 1 ADC. Based on FDA action dates, several additional product candidates could be approved by the end of 2022. An additional seven were first approved in China or Japan in 2022, including two bispecific antibodies (cadonilimab and ozoralizumab). Globally, at least 24 investigational antibody therapeutics are undergoing review by regulatory agencies as of mid-November 2022. Our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline grew by ~20% in the past year to include nearly 140 investigational antibody therapeutics that were designed using a wide variety of formats and engineering techniques. Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine).

01 Oct 2023·Lung cancer (Amsterdam, Netherlands)

The search for therapeutic targets in lung cancer: Preclinical and human studies of carcinoembryonic antigen-related cell adhesion molecule 5 expression and its associated molecular landscape

Article

Author: Angevin, Eric ; Lefebvre, Anne-Marie ; Demers, Brigitte ; Falda-Buscaiot, François ; Attenot, Florence ; Larois, Christelle ; Adam, Julien ; Henry, Christophe ; Bauchet, Anne-Laure ; Masson, Nina ; Soria, Jean-Charles ; Scoazec, Jean-Yves ; Chiron, Marielle ; Combeau, Cécile ; Sidhu, Sukhvinder ; Nicolazzi, Céline ; Naimi, Souad ; Chadjaa, Mustapha ; Ternès, Nils ; Dib, Colette

OBJECTIVES:

CEACAM5 is a cell-surface glycoprotein expressed on epithelial cells of some solid tumors. Tusamitamab ravtansine (SAR408701), a humanized antibody-drug conjugate targeting CEACAM5, is in clinical development for nonsquamous non-small cell lung cancer (NSQ-NSCLC) with CEACAM5 high expression (HE), defined as membranous CEACAM5 immunohistochemistry staining at ≥ 2+ intensity in ≥ 50% of tumor cells.

MATERIALS AND METHODS:

We investigated correlations between CEACAM5 expression by immunohistochemistry, CEACAM5 protein expression by ELISA, and CEACAM5 RNA expression by RNA-seq in NSQ-NSCLC patient-derived xenograft (PDX) models, and tumor responses to tusamitamab ravtansine in these models. We assessed prevalence of CEACAM5 HE, clinicopathologic characteristics and molecular markers in patients with NSQ-NSCLC in clinical cohorts.

RESULTS:

In a lung PDX set of 10 NSQ-NSCLC specimens, correlations between CEACAM5 by IHC, ELISA and RNA-seq ranged from 0.72 to 0.88. In a larger lung PDX set, higher H-scores were present in NSQ- (n = 93) vs SQ-NSCLC (n = 128) models, and in 12 of these NSQ-NSCLC models, more tumor responses to tusamitamab ravtansine occurred in CEACAM5 HE (5/8; 62.5%) versus moderate or negative expression (1/4; 25%), including 3 with KRAS mutations among the 6 responders. In clinical NSQ-NSCLC samples, CEACAM5 HE prevalence was (52/214; 24.3%) in primary tumors and (6/17; 35.3%) in metastases. In NSQ-NSCLC primary tumors, CEACAM5 HE prevalence was significantly higher in KRAS-altered versus wild-type (35.0% vs 19.5%; P = 0.028) and in programmed cell death ligand 1 (PD-L1) negative (tumor cells 0%)/low (1-49%) versus high (≥50%) (33.3%, 26.1%, 5.0%; P = 0.031), but not significantly different in EGFR-mutated versus wild-type (20.0% vs 25.7%, P = 0.626).

CONCLUSIONS:

In NSQ-NSCLC tumors, CEACAM5 HE prevalence was 24.3% overall and was higher with KRAS altered and with PD-L1 negative/low tumors but similar regardless of EGFR mutation status. These findings support targeting CEACAM5 and the clinical development of tusamitamab ravtansine for patients with NSQ-NSCLC with CEACAM5 HE.

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 SA	06 Feb 2020

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Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05245071 (CARMEN-LC06, ESMO_ELCC2025) Manual	Phase 2	Non-squamous non-small cell lung cancer	22	Tusamitamab ravtansine 100 mg/m²	kgcvdhwviq(mzsfplmefu) = soaapuohob zcrgfvqbyq (lisfpgkdqd, 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	codlrhkceh = vonghkrvcm eyfaiztzur (axqflqvadd, ulovtwwqwk - otglpgefbu) 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)	gxmztezulu = kwpdgpudzn kbeeqbhjuu (aoyfgkjruw, wljehwpxkb - bfzmkblfew) View more	-	25 Mar 2025
				tusamitamab ravtansine (Cohort B: mPAC)	gxmztezulu = soquemzznt kbeeqbhjuu (aoyfgkjruw, xrrfwergoq - zkrgcyovdy) 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)	tzifqrcmcs = sterdhwzdt psjkjblebg (qiilpgjshi, luajltibcf - wgjulponpz) View more	-	17 Mar 2025
				Ravtansine+Tusamitamab+Pembrolizumab (Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab)	tzifqrcmcs = tesrjfctga psjkjblebg (qiilpgjshi, lrfmrxrjzm - ixlobwrklf) View more
NCT05071053 (CARMEN-GC01, CTgov)	Phase 2	Adenocarcinoma \| stomach adenocarcinoma \| Gastrooesophageal junction cancer ... View more	35	Ravtansine+Tusamitamab+Ramucirumab	pwlqhxzhyq = abhykjgquc xtmjjqhueh (xrttaakwfo, mhbdrnrlvi - oxzdzepudy) 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	wibnljxtse(zlpleckfgs) = phowyflbwd ddkzeaebgl (ymspriojxp, dhpwshijfn - aydgsrjcme) 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	kifkjnrolm(reudvxsukt) = nlayqmrove ffghilzwzp (xaihwgdeos ) View more	Positive	14 Sep 2024
				Tusamitamab ravtansine 170 mg/m^2+ Pembrolizumab	kifkjnrolm(reudvxsukt) = ysdwaagqfq ffghilzwzp (xaihwgdeos ) View more
NCT04154956 (CARMEN-LC03, Corporate Publications) Manual	Phase 3	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma Second line	-	tusamitamab ravtansine	lfvagrdefc(upsntzvajf) = did not meet vrintayrmr (hcofjkmmre ) Not Met View more	Negative	21 Dec 2023
				docetaxel
NCT04394624 (CARMEN-LC04, ESMO 12023 \| ESMO 22023) Manual	Phase 2	metastatic non-small cell lung cancer Second line CEACAM5	31	Tusamitamab ravtansine+ ramucirumab	gtlxpbtkyn(kmlakuhirf) = efdnhsbtnq svybbpxglz (mhyztxwgxp ) View more	Positive	23 Oct 2023
NCT02187848 (AACR2023) Manual	Phase 1/2	Non-Small Cell Lung Cancer CEACAM5	92	tusamitamab ravtansine 100 mg/m2 (CEACAM5 high expressors)	ryrjeqtnel(ryxpromtto) = oxckggtmaj xbyenochcn (ohkvnvwcdk ) View more	Positive	14 Apr 2023
				tusamitamab ravtansine 100 mg/m2 (CEACAM5 moderate expressors)	ryrjeqtnel(mtxqsyaifb) = lvcxgruuqo dgnefkbkft (ppewlisvpb ) View more

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