New investigational clinical data for Ipsen’s oncology products in 11 solid tumor types to be presented at 2019 ASCO Annual Meeting

Paris (France), 24 May 2019 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that new data from clinical studies on investigational uses of cancer medicines cabozantinib (Cabometyx®), liposomal irinotecan (Onivyde®), and lanreotide autogel (Somatuline®, marketed as Somatuline Depot® in the United States) will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
The meeting takes place in Chicago, Illinois, U.S., 31 May–4 June 2019; data featuring Ipsen medicines includes:

New data from the Phase 3 CELESTIAL trial on the association of adverse events with efficacy outcomes for cabozantinib in patients with advanced hepatocellular carcinoma
Overview of the Phase 3 COSMIC-312 trial of cabozantinib in combination with atezolizumab vs sorafenib in patients with advanced hepatocellular carcinoma who have not received previous systemic anticancer therapy
First Phase 2 data from the CaboGIST study (trial 1317) from the European Organization for Research and Treatment of Cancer on the activity and safety of cabozantinib in patients with metastatic gastrointestinal stromal tumor after failure of imatinib and sunitinib
Preliminary results from the RESILIENT study of liposomal irinotecan injection in patients with small cell lung cancer
Results from a Phase 2 multicenter study of lanreotide autogel in the treatment of clinical symptoms associated with inoperable malignant intestinal obstruction

“At Ipsen, patients inspire and drive us to tackle some of the most difficult-to-treat cancers, particularly where few effective options exist. ASCO gives us the opportunity to share the progress we have made in our mission of developing and delivering therapeutic solutions that meet the real needs of patients and may help improve their lives,” said Dr. Alexandre Lebeaut, Ipsen’s Executive Vice President, R&D, and Chief Scientific Officer. “With our continued clinical programs and collaborations, we are making strides in renal, liver and small cell lung cancers and other cancers with high unmet need, and we look forward to continuing to advance these programs.”

Follow Ipsen on Twitter via @IpsenGroup and @IpsenUS and keep up to date with ASCO 2019 congress news and updates by using the hashtag #ASCO19.

Overview of key Ipsen presentations at ASCO 2019:

MEDICINE	ABSTRACT TITLE	ABSTRACT NUMBER/TIMING (CDT)
CABOMETYX®(CABOZANTINIB)	Phase 3 (COSMIC-311) randomized, double-blind, placebo-controlled study of cabozantinib in patients with radioiodine (RAI)-refractory differentiated thyroid cancer (DTC) who have progressed after prior VEGFR-targeted therapy	Abstract TPS6097 Poster 82a – Category: Head and Neck Cancer; Saturday, 1 June, 1:15 PM – 4:15 PM; Hall A TIP
	Association of adverse events (AEs) with efficacy outcomes for cabozantinib (C) in patients (pts) with advanced hepatocellular carcinoma (aHCC) in the Phase 3 CELESTIAL trial	Abstract 4088 Poster 193 – Category: Gastrointestinal (Noncolorectal) Cancer; Monday, 3 June, 8:00 AM – 11:00 AM; Hall A
	Phase 3 (COSMIC-312) study of cabozantinib (C) in combination with atezolizumab (A) vs sorafenib (S) in patients (pts) with advanced hepatocellular carcinoma (aHCC) who have not received previous systemic anticancer therapy	Abstract TPS4157 Poster 254a – Category: Gastrointestinal (Noncolorectal) Cancer; Monday, 3 June, 8:00 AM – 11:00 AM; Hall A TIP
ONIVYDE® (NAL-IRI/LIPOSOMAL IRINOTECAN)	RESILIENT: Study of Irinotecan Liposome Injection (nal-IRI) in Patients with Small Cell Lung Cancer: Preliminary Findings from Part 1 Dose-defining Phase	Abstract 8562 Poster 318 – Category: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers; Poster – Sunday, 2 June, 8:00 AM – 11:00 AM; Hall A
SOMATULINE® AUTOGEL® (LANREOTIDE AUTOGEL/DEPOT)	Efficacy and Safety of Lanreotide Autogel (LAN) 120 mg in the Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction (IMIO): Results From A Phase II Multicenter Study	Abstract 4118 Poster 223 – Category: Gastrointestinal (Noncolorectal) Cancer; Poster – Monday, 3 June, 8:00 AM – 11:00 AM; Hall A

Overview of key investigator sponsored study presentations featuring Ipsen medicines at ASCO 2019:

MEDICINE	ABSTRACT TITLE	ABSTRACT NUMBER/TIMING (CDT)
CABOMETYX®(CABOZANTINIB)	Activity and safety of cabozantinib in patients with metastatic gastrointestinal stromal tumor after failure of imatinib and sunitinib. European Organization for Research and Treatment of Cancer (EORTC) Phase 2 trial 1317 “CaboGIST” EORTC Sponsored Study	Abstract 11006 Oral: Category: Sarcoma; Monday, 3 June, 10:00 AM – 10:12 AM; E450
	PDIGREE: An adaptive Phase 3 trial of PD-inhibitor nivolumab and Ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated Renal Cell Cancer (Alliance A031704) NCI Sponsored Study	Abstract TPS4596 Poster 417a – Category: Genitourinary (Nonprostate) Cancer; Poster – Monday, 3 June, 1:15 PM – 4:15 PM; Hall A
	Prognostic value of sequential 18F-FDG + Na18F PET/CT (NaF+FDG PET) in metastatic genitourinary (GU) cancer patients (pts) treated with Cabozantinib/ Nivolumab +/- Ipilimumab (CaboNivoIpi) NCI Sponsored Study	Abstract 4544 Poster 370 – Category: Genitourinary (Nonprostate) Cancer; Poster – Monday, 3 June, 1:15 PM – 4:15 PM; Hall A
	Circulating tumor cell (CTC) enumeration in patients (pts) with metastatic genitourinary (mGU) tumors treated in a phase I study of cabozantinib and nivolumab (CaboNivo) +/- ipilimumab (CaboNivoIpi)	Abstract 4555 Poster 381 – Category: Genitourinary (Nonprostate) Cancer; Poster – Monday, 3 June, 1:15 PM – 4:15 PM; Hall A
	Correlates of overall survival (OS) in metastatic vs. primary uveal melanoma (UM) and results of a randomized trial of cabozantinib (cabo) vs. chemotherapy (chemo) Alliance A091201 NCI Sponsored Study	Abstract 9506 – Oral: Category: Melanoma/Skin Cancers; Poster – Tuesday, 4 June, 11:45 AM – 11:57 AM; S406
ONIVYDE® (NAL-IRI/LIPOSOMAL IRINOTECAN)	A multicenter phase Ib/II study of nalirinotecan, 5fluouracil and leucovorin in combination with nivolumab as second-line therapy for patients with advanced unresectable biliary tract cancer	Abstract TPS4154 Poster 252b – Category: Gastrointestinal (Noncolorectal) Cancer; Poster – Monday, 3 June, 8:00 AM – 11:00 AM; Hall A

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