New Cabometyx® knowledge present encouraging ends in monotherapy and together throughout totally different tumor sorts together with metastatic non-small cell lung most cancers

• COSMIC-021 Section Ib examine is evaluating Cabometyx^® (cabozantinib) together with atezolizumab in superior stable tumors, together with non-small cell lung most cancers

• New analyses from pivotal Section III Checkmate -9ER trial additional help the superior efficacy of Cabometyx and nivolumab over sunitinib in superior renal cell carcinoma

• Two new analyses from pivotal Section III COSMIC-311 trial additional help the potential of Cabometyx in radioactive iodine-refractory differentiated thyroid most cancers

PARIS, FRANCE, 26 Might 2022 – Ipsen (Euronext: IPN; ADR: IPSEY) at the moment introduced encouraging knowledge to be introduced for the multi-targeted tyrosine kinase inhibitor (TKI), Cabometyx^® (cabozantinib), throughout a variety of most cancers sorts at this 12 months’s American Society of Medical Oncology Annual Assembly (ASCO 2022) to be held on 3-7 June. Knowledge shows will embrace findings in metastatic non-small cell lung most cancers (NSCLC), in addition to established indications of superior renal cell carcinoma and radioactive iodine-refractory differentiated thyroid most cancers (RAI-R DTC). These knowledge present that the therapeutic potential of Cabometyx as a key remedy possibility in a broad vary of tumors is constant to be realized.

Up to date outcomes from the multicenter Section Ib COSMIC-021 trial evaluating the mixture of Cabometyx plus atezolizumab in an expanded affected person inhabitants in metastatic NSCLC exhibit encouraging medical exercise with manageable toxicity in individuals beforehand handled with an immune checkpoint inhibitor (ICI).[i] These knowledge lay the foundations for the potential of Cabometyx in metastatic NSCLC which is being additional examined within the ongoing Section III CONTACT-01 trial. This trial is evaluating the mixture of Cabometyx plus atezolizumab vs docetaxel in sufferers with metastatic NSCLC beforehand handled with an ICI and platinum-containing chemotherapy, and topline outcomes of the examine are anticipated to be introduced within the second half of 2022.

“At the moment, first-line immunotherapy with or with out chemotherapy is the usual of look after sufferers with metastatic NSCLC however there’s a actual want for extra efficient remedy choices for these sufferers who progress after a previous immunotherapy,” stated Santiago Ponce-Aix, M.D., Head of Drug Improvement Division, Institute Gustave Roussy, France, and an investigator within the COSMIC-021 trial. “These new knowledge are encouraging as they present the potential position of Cabometyx in creating an setting which can improve atezolizumab’s exercise in NSCLC. We sit up for additional knowledge evaluating this mix for this affected person inhabitants the place there stays such a excessive unmet medical want.”

“The therapeutic potential of Cabometyx as a remedy possibility in opposition to a broad vary of tumors together with NSCLC is constant to be evaluated and these knowledge exhibit our ambition to convey significant new remedies to sufferers. These newest knowledge help the potential position of Cabometyx to positively influence remedy when paired with immunotherapy, and we’ll proceed to guage Cabometyx as each a monotherapy and together with different revolutionary therapies for essentially the most difficult-to-treat cancers,” stated Dr. Howard Mayer, Govt Vice President and Head of Analysis and Improvement at Ipsen.

An exploratory evaluation may even be introduced investigating the connection between depth of response (DepOR) and medical outcomes in CheckMate -9ER, evaluating Cabometyx together with nivolumab vs sunitinib in beforehand untreated superior renal cell carcinoma.^[ii] DepOR was outlined as the most effective p.c discount from baseline in sum of diameters of goal lesions. General, better proportions of sufferers receiving Cabometyx plus nivolumab demonstrated deeper responses vs sunitinib. No matter remedy, deeper responses had been usually related to improved progression-free survival (PFS) and total survival.²

Moreover, two new knowledge analyses from the pivotal Section III trial COSMIC-311 evaluating Cabometyx in RAI-R DTC can be introduced. One evaluation pertains to outcomes for prespecified subgroups based mostly on the baseline histology subtypes of papillary and follicular thyroid cancers, with outcomes displaying Cabometyx maintained superior efficacy vs placebo regardless of histology subtype.[iii]  Median PFS was 9.2 months for Cabometyx vs 1.9 months for placebo within the papillary thyroid most cancers (PTC) subgroup (HR 0.27 95% CI, 0.17-0.43) and 11.2 months vs 2.5 months within the follicular thyroid most cancers (FTC) subgroup (HR 0.18 95% CI, 0.10-0.31). The general response price (ORR) was 15% for Cabometyx vs 0% for placebo within the PTC subgroup and eight% vs 0% within the FTC subgroup.³

One other evaluation can be introduced associated to outcomes for prespecified subgroups who obtained prior lenvatinib and/or sorafenib remedy. The info from this evaluation confirmed Cabometyx maintained its PFS vs placebo regardless of prior lenvatinib and/or sorafenib remedy.^[iv] Median PFS throughout the totally different teams included 16.6 months for Cabometyx vs 3.2 months for placebo in prior sorafenib (no lenvatinib) (HR 0.13, 95% CI 0.06–0.26), 5.8 months vs 1.9 months in prior lenvatinib (no sorafenib) (HR 0.28, 95% CI 0.16-0.48), and seven.6 months vs 1.9 months in prior sorafenib and lenvatinib (HR 0.27, 95% CI 0.13–0.54).⁴

The security profile recognized in COSMIC-021, CheckMate -9ER and COSMIC-311 was in line with that beforehand noticed for Cabometyx in monotherapy and together.

Ipsen thanks the sufferers and investigators concerned within the COSMIC-021, CheckMate -9ER and COSMIC-311 medical trials.

ENDS

Extra info could be discovered in the course of the presentation classes outlined under:

About non-small cell lung most cancers (NSCLC)

Lung most cancers is among the main causes of most cancers dying globally.[vi] There are broadly two totally different teams of lung most cancers – NSCLC and SCLC (small cell lung most cancers). NSCLC accounts for round 80-85% of all circumstances.[vii] The primary subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and enormous cell carcinoma. These subtypes, which begin from various kinds of lung cells are grouped collectively as NSCLC as a result of their remedy and prognoses are sometimes related.⁷

About renal cell carcinoma (RCC)

There have been over 430,000 new circumstances of kidney most cancers identified worldwide in 2020.[viii] Of those, RCC is the most typical sort of kidney most cancers, accounting for roughly 90% of circumstances.[ix]^,[x] It’s nearly twice as frequent in males, and male sufferers account for over two thirds of deaths.⁹ If detected within the early phases, the five-year survival price is excessive, however for sufferers with or late-stage metastatic RCC the survival price is far decrease, round 12%, with no recognized treatment for this illness.[xi]^,[xii]

About radioactive iodine-refractory differentiated thyroid most cancers (RAI-R DTC)

In 2020, over 580,000 new circumstances of thyroid most cancers had been identified worldwide.[xiii] Thyroid most cancers is the ninth mostly occurring most cancers globally and incidence is thrice larger in girls than in males, with the illness representing one in each 20 cancers identified amongst girls.¹³ Whereas cancerous thyroid tumors embrace differentiated, medullary and anaplastic types, differentiated thyroid most cancers (DTC) makes up about 90 to 95% of circumstances.[xiv]^,[xv] DTC is often handled with surgical procedure, adopted by ablation of the remaining thyroid tissue with radioactive iodine (RAI), however roughly 5 to fifteen% of circumstances are proof against RAI remedy.[xvi] Sufferers who develop RAI-R DTC have a poor prognosis with a median estimated survival of three to 5 years.[xvii]

Concerning the COSMIC-021 trial[xviii]

COSMIC-021 is a multicenter, Section Ib, open-label examine that was divided into two elements: a dose-escalation part and an enlargement cohort part. Within the enlargement part, the trial enrolled 23 cohorts in 12 tumor sorts: NSCLC, RCC, UC, castration-resistant prostate most cancers, hepatocellular carcinoma, triple-negative breast most cancers, epithelial ovarian most cancers, endometrial most cancers, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, head and neck most cancers, and DTC. Exelixis is the examine sponsor of COSMIC-021. Each Ipsen and Takeda Pharmaceutical Firm Restricted (Takeda) have opted in to take part within the trial and are contributing to the funding for this examine below the phrases of the businesses’ respective collaboration agreements with Exelixis. Roche is offering atezolizumab for the trial.

Concerning the CheckMate -9ER trial[xix]

CheckMate -9ER was an open-label, randomized, multi-national Section III trial evaluating individuals dwelling with beforehand untreated superior or metastatic RCC. A complete of 651 sufferers (23% favorable threat, 58% intermediate threat, 20% poor threat; 25% PD-L1 ≥1%) had been randomized to Cabometyx plus nivolumab (n= 323) versus sunitinib (n=328). The first endpoint was progression-free survival (PFS). The secondary endpoints included total survival (OS) and goal response price (ORR). The first efficacy evaluation in contrast the doublet mixture versus sunitinib in all randomized sufferers. The trial was sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen and Takeda.

Concerning the COSMIC-311 trial[xx]

COSMIC-311 was a multicenter, randomized, double-blind, placebo-controlled Section III trial that enrolled 258 sufferers at 164 websites globally. Sufferers had been randomized in a 2:1 ratio to obtain both Cabometyx 60 mg or placebo once-daily. The first endpoints had been progression-free survival within the intention-to-treat inhabitants in addition to goal response price within the first 100 randomly assigned sufferers (goal response price intention-to-treat [OITT] inhabitants), each evaluated by a blinded impartial radiology committee. Extra endpoints included security, total survival and high quality of life. Exelixis is the sponsor, and Ipsen is co-funding the COSMIC-311 trial.

About Cabometyx (cabozantinib)

Outdoors the USA and Japan, Cabometyx is at present accredited in 60 international locations, together with within the European Union (E.U.), Nice Britain, Norway, Iceland, Australia, New Zealand, Switzerland, South Korea, Canada, Brazil, Taiwan, Hong Kong, Singapore, Macau, Jordan, Lebanon, the Russian Federation, Ukraine, Turkey, the United Arabic Emirates (U.A.E.), Saudi Arabia, Serbia, Israel, Mexico, Chile, Peru, Panama, Guatemala, the Dominican Republic, Ecuador, Thailand, Malaysia, Colombia, Egypt and Kazakhstan for the remedy of superior renal cell carcinoma (RCC) in adults who’ve obtained prior vascular endothelial progress issue (VEGF)-targeted remedy; within the E.U., Nice Britain, Norway, Iceland, Canada, Australia, New Zealand, Brazil, Taiwan, Hong Kong, Singapore, Lebanon, Jordan, the Russian Federation, Ukraine, Turkey, the U.A.E., Saudi Arabia, Israel, Serbia, Mexico, Chile, Peru, Panama, Guatemala, the Dominican Republic, Ecuador, Thailand, Egypt, Malaysia and Kazakhstan for beforehand untreated intermediate- or poor-risk superior RCC; and within the E.U., Nice Britain, Norway, Iceland, Canada, Australia, Switzerland, Saudi Arabia, Serbia, Israel, Taiwan, Hong Kong, South Korea, Singapore, Jordan, the Russian Federation, Ukraine, Turkey, Lebanon, the U.A.E., Peru, Panama, Guatemala, Chile, the Dominican Republic, Ecuador, Thailand, Brazil, New Zealand, Egypt, Malaysia and Kazakhstan for hepatocellular carcinoma (HCC) in adults who’ve beforehand been handled with sorafenib. Cabometyx is accredited together with nivolumab as first-line remedy for individuals dwelling with superior RCC, within the E.U., Nice Britain, Norway, Iceland, Switzerland, Canada, Taiwan, Singapore, the U.A.E., Australia, Chile, Israel, Thailand, Malaysia, South Korea, Saudi Arabia, the Russian Federation, Brazil and Kazakhstan. Cabometyx can also be accredited within the E.U., Nice Britain and Canada as a monotherapy for the remedy of grownup sufferers with regionally superior or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine who’ve progressed throughout or after prior systemic remedy. Within the U.S., Cabometyx tablets are accredited for the remedy of individuals dwelling with superior RCC; for the remedy of individuals dwelling with HCC who’ve been beforehand handled with sorafenib; for sufferers with superior RCC as a first-line remedy together with nivolumab; and for adults and pediatric sufferers 12 years of age and older with regionally superior or metastatic DTC.

The detailed suggestions for the usage of Cabometyx are described within the Summary of Product Characteristics (EU SmPC)* and within the U.S. Prescribing Information (USPI).

Ipsen has unique rights for the commercialization of Cabometyx exterior the U.S. and Japan. Cabometyx is marketed by Exelixis within the U.S. and by Takeda in Japan. Cabometyx is a registered trademark of Exelixis.

*This SmPC doesn’t embrace particulars of the approval of Cabometyx on 3 Might 2022 to be used within the E.U. within the remedy of grownup sufferers with regionally superior or metastatic DTC, refractory or not eligible to radioactive iodine who’ve progressed throughout or after prior systemic remedy. Extra info could be discovered on the European Commission’s website.

About Ipsen 

Ipsen is a worldwide, mid-sized biopharmaceutical firm targeted on transformative medicines in Oncology, Uncommon Illness and Neuroscience. With Specialty Care gross sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 international locations. Alongside its external-innovation technique, the Firm’s analysis and improvement efforts are targeted on its revolutionary and differentiated technological platforms situated within the coronary heart of main biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.Okay.; Cambridge, U.S.; Shanghai, China. Ipsen, excluding its Shopper HealthCare enterprise, has round 4,500 colleagues worldwide and is listed in Paris (Euronext: IPN) and within the U.S. by means of a Sponsored Degree I American Depositary Receipt program (ADR: IPSEY). For extra info, go to ipsen.com

Ipsen’s Ahead-Wanting Statements

The forward-looking statements, aims and targets contained herein are based mostly on Ipsen’s administration technique, present views and assumptions. Such statements contain identified and unknown dangers and uncertainties that will trigger precise outcomes, efficiency or occasions to vary materially from these anticipated herein. All the above dangers may have an effect on Ipsen’s future capacity to attain its monetary targets, which had been set assuming cheap macroeconomic situations based mostly on the data obtainable at the moment. Use of the phrases ‘believes’, ‘anticipates’ and ‘expects’ and related expressions are meant to establish forward-looking statements, together with Ipsen’s expectations relating to future occasions, together with regulatory filings and determinations. Furthermore, the targets described on this doc had been ready with out considering exterior progress assumptions and potential future acquisitions, which can alter these parameters. These aims are based mostly on knowledge and assumptions thought to be cheap by Ipsen. These targets rely on situations or info prone to occur sooner or later, and never completely on historic knowledge. Precise outcomes could depart considerably from these targets given the incidence of sure dangers and uncertainties, notably the truth that a promising drugs in early improvement part or medical trial could find yourself by no means being launched available on the market or reaching its industrial targets, notably for regulatory or competitors causes. Ipsen should face or would possibly face competitors from generic drugs that may translate right into a lack of market share. Moreover, the analysis and improvement course of includes a number of phases every of which includes the substantial threat that Ipsen could fail to attain its aims and be compelled to desert its efforts close to a drugs during which it has invested important sums. Subsequently, Ipsen can’t be sure that favorable outcomes obtained throughout preclinical trials can be confirmed subsequently throughout medical trials, or that the outcomes of medical trials can be adequate to exhibit the protected and efficient nature of the medication involved. There could be no ensures a drugs will obtain the required regulatory approvals or that the medication will show to be commercially profitable. If underlying assumptions show inaccurate or dangers or uncertainties materialize, precise outcomes could differ materially from these set forth within the forward-looking statements. Different dangers and uncertainties embrace however aren’t restricted to, normal trade situations and competitors; normal financial elements, together with rate of interest and forex change price fluctuations; the influence of pharmaceutical trade regulation and healthcare laws; world traits towards healthcare price containment; technological advances, new drugs and patents attained by opponents; challenges inherent in new-medicine improvement, together with acquiring regulatory approval; Ipsen’s capacity to precisely predict future market situations; manufacturing difficulties or delays; monetary instability of worldwide economies and sovereign threat; dependence on the effectiveness of Ipsen’s patents and different protections for revolutionary medicines; and the publicity to litigation, together with patent litigation, and/or regulatory actions. Ipsen additionally relies on third events to develop and market a few of its medicines which may doubtlessly generate substantial royalties; these companions may behave in such methods which may trigger injury to Ipsen’s actions and monetary outcomes. Ipsen can’t be sure that its companions will fulfil their obligations. It could be unable to acquire any profit from these agreements. A default by any of Ipsen’s companions may generate decrease revenues than anticipated. Such conditions may have a detrimental influence on Ipsen’s enterprise, monetary place or efficiency. Ipsen expressly disclaims any obligation or enterprise to replace or revise any forward-looking statements, targets or estimates contained on this press launch to mirror any change in occasions, situations, assumptions or circumstances on which any such statements are based mostly, until so required by relevant legislation. Ipsen’s enterprise is topic to the chance elements outlined in its registration paperwork filed with the French Autorité des Marchés Financiers. The dangers and uncertainties set out aren’t exhaustive and the reader is suggested to consult with Ipsen’s 2021 Common Registration Doc, obtainable on ipsen.com

For additional info:

1. Cabozantinib (C) Plus Atezolizumab (A) in Sufferers (Pts) With Superior Non-Small Cell Lung Most cancers (NSCLC) Beforehand Handled With an Immune Checkpoint Inhibitor (ICI): Outcomes from Cohorts 7 and 20 of the COSMIC-021 Examine

2. Affiliation between depth of response and medical outcomes: exploratory evaluation in sufferers with beforehand untreated superior renal cell carcinoma (aRCC) in CheckMate 9ER

3. Cabozantinib versus placebo in sufferers (pts) with radioiodine-refractory (RAIR) differentiated thyroid most cancers (DTC) who’ve progressed after prior VEGFR-targeted remedy: outcomes in prespecified subgroups based mostly on histology subtypes

4. Cabozantinib (C) versus placebo (P) in sufferers (pts) with radioiodine-refractory (RAIR) differentiated thyroid most cancers (DTC) who’ve progressed after prior VEGFR-targeted remedy: outcomes in prespecified subgroups based mostly on prior VEGFR-targeted remedy

5. Cabozantinib (C) in Mixture With Atezolizumab (A) in Urothelial Carcinoma (UC): Outcomes From Cohorts 3, 4, 5 of the COSMIC-021 Examine

6. World Well being Group: GLOBOCAN 2020 – Lung Most cancers: Estimated most cancers incidence, mortality and prevalence worldwide. [Internet; cited September 2021] Obtainable from: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pd

7. American Most cancers Society. What’s Lung Most cancers? Might 2022. Obtainable: https://www.most cancers.org/most cancers/lung-cancer/about/what-is.html

8. Kidney Most cancers Factsheet. GLOBOCAN 2020. Accessed: Might 2022. Obtainable: https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf

9. Kidney Most cancers. Mayo Clinic. Accessed: Might 2022. Obtainable: https://www.mayoclinic.org/diseases-conditions/kidney-cancer/symptoms-causes/syc-20352664

10. Infographic: Kidney Most cancers. Mayo Clinic. Accessed: Might 2022. Obtainable: https://www.mayoclinic.org/diseases-conditions/kidney-cancer/multimedia/kidney-cancer-infographic/ifg-20441505

11. Survival charges for kidney most cancers. American Most cancers Society. Accessed: Might 2022. Obtainable: https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html

12. Orlin, I et al., Renal cell carcinomas epidemiology within the period of widespread imaging. Journal of Medical Oncology. 2019; 37:15

13. Sung. H et al. World most cancers statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 international locations. CA: A Most cancers Journal For Clinicians. doi: 10.3322/caac.21660..

14. Most cancers.Web. ASCO. Thyroid Most cancers: Introduction. Final accessed: Might 2022. Obtainable at: https://www.cancer.net/cancer-types/thyroid-cancer/introduction.

15. Chen D. et al. Progressive evaluation of distant metastasis in differentiated thyroid most cancers. Oncol Lett 19: 1985- 1992, 2020. doi: 10.3892/ol.2020.11304

16. Worden F. Remedy methods for radioactive iodine-refractory differentiated thyroid most cancers. Ther Adv Med Oncol. 6:267–279. doi: 10.1177/1758834014548188.

17. Fugazzola L. et al. 2019 European Thyroid Affiliation Tips for the Remedy and Observe-Up of Superior Radioiodine-Refractory Thyroid Most cancers. Eur Thyroid J. 2019;8:227–245. doi: 10.1159/000502229.

18. ClinicalTrials.gov. Examine of Cabozantinib in Mixture With Atezolizumab to Topics With Regionally Superior or Metastatic Strong Tumors (NCT03170960). Might 2022. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT03170960

19. ClinicalTrials.gov. A Examine of Nivolumab Mixed With Cabozantinib In comparison with Sunitinib in Beforehand Untreated Superior or Metastatic Renal Cell Carcinoma (CheckMate 9ER) (NCT03141177). Might 2022. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT03141177

20. ClinicalTrials.gov. A Examine of Cabozantinib In contrast With Placebo in Topics With Radioiodine-refractory Differentiated Thyroid Most cancers Who Have Progressed After Prior Vascular Endothelial Development Issue Receptor (VEGFR) -Focused Remedy (NCT03690388). Might 2022. Obtainable at: https://clinicaltrials.gov/ct2/show/NCT03690388

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