Oncology Pipeline

Research & Development

Our Pipeline

At Servier Pharmaceuticals, our core business is focused in oncology where we believe that we have a unique opportunity to redefine how cancer is treated. We are committed to finding solutions that will address today's challenges. We aim to understand the needs of our patients at all points of their journey, while ensuring those who can benefit from our products have access to them. Advancing innovation for patients is at the heart of everything we do. Servier has significantly accelerated its investment in hard-to-treat cancers with more than 50% of research and development dedicated to deliver significant advances in areas of high unmet need that may truly move the needle for our patients.

Servier’s pipeline includes many oncology assets at varying stages of clinical development

Hematological Malignancies

Molecule Area	Primary Indication	Partner	Territory	Phase

ONCASPAR^® (pegaspargase)	ALL		World	Registered
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia		PARTNER		PARTNER World
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia PARTNER TERRITORY World
	First Line Acute Lymphoblastic Leukemia		World
ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with first line acute lymphoblastic leukemia (ALL), ALL and hypersensitivity to native forms of L-asparaginase. Additional Information
ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with first line acute lymphoblastic leukemia (ALL), ALL and hypersensitivity to native forms of L-asparaginase. Additional Information

ASPARLAS^® (calaspargase pegol-mknl)	ALL		World	Registered
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia		PARTNER		PARTNER World
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia PARTNER TERRITORY World
	First Line Acute Lymphoblastic Leukemia		World
ASPARLAS is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of ALL in pediatric and young adult patients aged 1 month to 21 years. Additional Information
ASPARLAS is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of ALL in pediatric and young adult patients aged 1 month to 21 years. Additional Information

TIBSOVO® (ivosidenib tablets)	IDH1-AML		World except for China	Registered
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia with a IDH1-mutation		PARTNER Acquired by Servier from Agios Pharmaceuticals in 2021		PARTNER World except for China
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia with a IDH1-mutation PARTNER Acquired by Servier from Agios Pharmaceuticals in 2021 TERRITORY World except for China
	Relapsed or Refractory Acute Myeloid Leukemia with a IDH1-mutation	Acquired by Servier from Agios Pharmaceuticals in 2021	World except for China
TIBSOVO (ivosidenib tablets) is indicated in the U.S. for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA test in adult patients newly-diagnosed with AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy or adult patients with relapsed or refractory AML. Additional Information
TIBSOVO (ivosidenib tablets) is indicated in the U.S. for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA test in adult patients newly-diagnosed with AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy or adult patients with relapsed or refractory AML. Additional Information

IDHIFA ® (enasidenib)	IDH2-mutant R/R AML	Bristol Myers Squibb	United States	Registered
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia with a IDH2-mutation		PARTNER Servier acquired U.S. co-promotion and milestone rights for IDHIFA in 2021 from Agios Pharmaceuticals		PARTNER United States
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia with a IDH2-mutation PARTNER Servier acquired U.S. co-promotion and milestone rights for IDHIFA in 2021 from Agios Pharmaceuticals TERRITORY United States
	Relapsed or Refractory Acute Myeloid Leukemia with a IDH2-mutation	Servier acquired U.S. co-promotion and milestone rights for IDHIFA in 2021 from Agios Pharmaceuticals	United States
IDHIFA (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. Additional Information
IDHIFA (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. Additional Information

PIXURVI^® (pixantrone)	NHL		World	Registered
PRIMARY INDICATION Relapsed or Refractory Non-Hodgkin Lymphoma		PARTNER		PARTNER World
PRIMARY INDICATION Relapsed or Refractory Non-Hodgkin Lymphoma PARTNER TERRITORY World
	Relapsed or Refractory Non-Hodgkin Lymphoma		World
PIXURVI is indicated for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-Cell Lymphoma. PIXURVI is not registered in the United States.
PIXURVI is indicated for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-Cell Lymphoma. PIXURVI is not registered in the United States.

MCL1 Inhibitor	AML	Novartis/Vernalis	World except for North America and Japan	Phase 1
PRIMARY INDICATION Acute Myeloid Leukemia*		PARTNER Novartis/Vernalis		PARTNER World except for North America and Japan
PRIMARY INDICATION Acute Myeloid Leukemia* PARTNER Novartis/Vernalis TERRITORY World except for North America and Japan
	Acute Myeloid Leukemia*	Novartis/Vernalis	World except for North America and Japan
*In combination with BCL-2 Inhibitor
*In combination with BCL-2 Inhibitor

BCL-2 Inhibitor	R/R AML + NHL + MM	Novartis/Vernalis	World except for North America and Japan	Phase 1
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia, Non-Hodgkin’s Lymphoma, Multiple Myeloma		PARTNER Novartis/Vernalis		PARTNER World except for North America and Japan
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia, Non-Hodgkin’s Lymphoma, Multiple Myeloma PARTNER Novartis/Vernalis TERRITORY World except for North America and Japan
	Relapsed or Refractory Acute Myeloid Leukemia, Non-Hodgkin’s Lymphoma, Multiple Myeloma	Novartis/Vernalis	World except for North America and Japan

BCL- 2 Inhibitor	R/R AML	Novartis/Vernalis	World except for North America and Japan	Phase 1
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia		PARTNER Novartis/Vernalis		PARTNER World except for North America and Japan
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia PARTNER Novartis/Vernalis TERRITORY World except for North America and Japan
	Relapsed or Refractory Acute Myeloid Leukemia	Novartis/Vernalis	World except for North America and Japan

BCL-2 Inhibitor	R/R NHL	Novartis/Vernalis	World except for North America and Japan	Phase 1
PRIMARY INDICATION Relapsed or Refractory Non-Hodgkin’s Lymphoma		PARTNER Novartis/Vernalis		PARTNER World except for North America and Japan
PRIMARY INDICATION Relapsed or Refractory Non-Hodgkin’s Lymphoma PARTNER Novartis/Vernalis TERRITORY World except for North America and Japan
	Relapsed or Refractory Non-Hodgkin’s Lymphoma	Novartis/Vernalis	World except for North America and Japan

BCL-2 Inhibitor	R/R MM	Novartis/Vernalis	World except for North America and Japan	Phase 1
PRIMARY INDICATION Relapsed or Refractory Multiple Myeloma		PARTNER Novartis/Vernalis		PARTNER World except for North America and Japan
PRIMARY INDICATION Relapsed or Refractory Multiple Myeloma PARTNER Novartis/Vernalis TERRITORY World except for North America and Japan
	Relapsed or Refractory Multiple Myeloma	Novartis/Vernalis	World except for North America and Japan

BCL-2 Inhibitor	R/R CLL	Novartis/Vernalis	Phase 1
PRIMARY INDICATION Relapsed or Refractory Chronic Lymphocytic Leukemia		PARTNER Novartis/Vernalis	PARTNER
PRIMARY INDICATION Relapsed or Refractory Chronic Lymphocytic Leukemia PARTNER Novartis/Vernalis TERRITORY
	Relapsed or Refractory Chronic Lymphocytic Leukemia	Novartis/Vernalis

Anti-CD19	R/R ALL Pediatric	Allogene Therapeutics	World except for the United States	Phase 1
PRIMARY INDICATION Relapsed or Refractory Acute Lymphoblastic Leukemia Pediatric*		PARTNER Allogene Therapeutics		PARTNER World except for the United States
PRIMARY INDICATION Relapsed or Refractory Acute Lymphoblastic Leukemia Pediatric* PARTNER Allogene Therapeutics TERRITORY World except for the United States
	Relapsed or Refractory Acute Lymphoblastic Leukemia Pediatric*	Allogene Therapeutics	World except for the United States
*Based on Cellectis TALEN® genome editing platform
*Based on Cellectis TALEN® genome editing platform

Anti-CD19	R/R ALL Adult	Allogene Therapeutics	World except for the United States	Phase 1
PRIMARY INDICATION Relapsed or Refractory Acute Lymphoblastic Leukemia Adult*		PARTNER Allogene Therapeutics		PARTNER World except for the United States
PRIMARY INDICATION Relapsed or Refractory Acute Lymphoblastic Leukemia Adult* PARTNER Allogene Therapeutics TERRITORY World except for the United States
	Relapsed or Refractory Acute Lymphoblastic Leukemia Adult*	Allogene Therapeutics	World except for the United States
*Based on Cellectis TALEN® genome editing platform
*Based on Cellectis TALEN® genome editing platform

Anti-CD19	R/R NHL	Allogene Therapeutics	World except for the United States	Phase 1
PRIMARY INDICATION Relapsed or Refractory Non-Hodgkin’s Lymphoma*		PARTNER Allogene Therapeutics		PARTNER World except for the United States
PRIMARY INDICATION Relapsed or Refractory Non-Hodgkin’s Lymphoma* PARTNER Allogene Therapeutics TERRITORY World except for the United States
	Relapsed or Refractory Non-Hodgkin’s Lymphoma*	Allogene Therapeutics	World except for the United States
*Based on Cellectis TALEN® genome editing platform
*Based on Cellectis TALEN® genome editing platform

Ivosidenib	IDH1-mutant R/R MDS		World except for China	Phase 1
PRIMARY INDICATION Relapsed or Refractory Myelodysplastic Syndrome		PARTNER		PARTNER World except for China
PRIMARY INDICATION Relapsed or Refractory Myelodysplastic Syndrome PARTNER TERRITORY World except for China
	Relapsed or Refractory Myelodysplastic Syndrome		World except for China

Ivosidenib	IDH1-mutant IC-Ineligible Frontline AML		Phase 3
PRIMARY INDICATION First line Acute Myeloid Leukemia with IDH1 Mutation		PARTNER	PARTNER
PRIMARY INDICATION First line Acute Myeloid Leukemia with IDH1 Mutation PARTNER TERRITORY
	First line Acute Myeloid Leukemia with IDH1 Mutation
An ongoing phase 3 study, the AGILE trial is evaluating Ivosidenib + Azacitidine in adults with newly diagnosed AML and the IDH1 mutation who are not candidates for intensive treatment.
An ongoing phase 3 study, the AGILE trial is evaluating Ivosidenib + Azacitidine in adults with newly diagnosed AML and the IDH1 mutation who are not candidates for intensive treatment.

Ivosidenib	IDH1-mutant IC-Eligible Frontline AML		World except for China	Phase 3
PRIMARY INDICATION Intensive Chemotherapy-Eligible Acute Myeloid Leukemia		PARTNER		PARTNER World except for China
PRIMARY INDICATION Intensive Chemotherapy-Eligible Acute Myeloid Leukemia PARTNER TERRITORY World except for China
	Intensive Chemotherapy-Eligible Acute Myeloid Leukemia		World except for China
HOVON 150 AML/AMLSG 29-18 is a phase 3, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in IC-eligible patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with excess blasts-2, with an IDH1 or IDH2 mutation
HOVON 150 AML/AMLSG 29-18 is a phase 3, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in IC-eligible patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with excess blasts-2, with an IDH1 or IDH2 mutation

Solid Tumors

Molecule Area	Primary Indication	Partner	Territory	Phase

LONSURF^® (trifluridine/tipiracil)	mCRC Third Line	Taiho Pharmaceutical Co.	World except for the United States	Registered
PRIMARY INDICATION Third line metastatic Colorectal Cancer		PARTNER Taiho Pharmaceutical Co.		PARTNER World except for the United States
PRIMARY INDICATION Third line metastatic Colorectal Cancer PARTNER Taiho Pharmaceutical Co. TERRITORY World except for the United States
	Third line metastatic Colorectal Cancer	Taiho Pharmaceutical Co.	World except for the United States
LONSURF (trifluridine and tipiracil) is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Additional Information
LONSURF (trifluridine and tipiracil) is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Additional Information

LONSURF^® (trifluridine/tipiracil)	mCRC Third Line	Taiho Pharmaceutical Co.	World except for North America and Asia	Phase 2
PRIMARY INDICATION Third line metastatic colorectal cancer with acquired EGFR resistance		PARTNER Taiho Pharmaceutical Co.		PARTNER World except for North America and Asia
PRIMARY INDICATION Third line metastatic colorectal cancer with acquired EGFR resistance PARTNER Taiho Pharmaceutical Co. TERRITORY World except for North America and Asia
	Third line metastatic colorectal cancer with acquired EGFR resistance	Taiho Pharmaceutical Co.	World except for North America and Asia
*In combination with an EGFR inhibitor Additional Information
*In combination with an EGFR inhibitor Additional Information

LONSURF^® (trifluridine/tipiracil)	mCRC First Line	Taiho Pharmaceutical Co.	World except for North America and Asia	Phase 3
PRIMARY INDICATION First and third line metastatic Colorectal Cancer*		PARTNER Taiho Pharmaceutical Co.		PARTNER World except for North America and Asia
PRIMARY INDICATION First and third line metastatic Colorectal Cancer* PARTNER Taiho Pharmaceutical Co. TERRITORY World except for North America and Asia
	First and third line metastatic Colorectal Cancer*	Taiho Pharmaceutical Co.	World except for North America and Asia
*In combination with bevacizumab
*In combination with bevacizumab

LONSURF^® (trifluridine/tipiracil)	mGC Third Line		World except for North America and Asia	Registered
PRIMARY INDICATION Third line metastatic Gastric Cancer		PARTNER Taiho Pharmaceutical Co.		PARTNER World except for North America and Asia
PRIMARY INDICATION Third line metastatic Gastric Cancer PARTNER Taiho Pharmaceutical Co. TERRITORY World except for North America and Asia
	Third line metastatic Gastric Cancer	Taiho Pharmaceutical Co.	World except for North America and Asia
LONSURF (trifluridine and tipiracil) is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Additional Information
LONSURF (trifluridine and tipiracil) is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Additional Information

ONIVYDE^® (Liposomal irinotecan)	mPAC post-gemcitabine	Ipsen	World except for the United States and Taiwan	Registered
PRIMARY INDICATION Post-gemcitabine Metastatic Pancreatic Cancer		PARTNER Ipsen		PARTNER World except for the United States and Taiwan
PRIMARY INDICATION Post-gemcitabine Metastatic Pancreatic Cancer PARTNER Ipsen TERRITORY World except for the United States and Taiwan
	Post-gemcitabine Metastatic Pancreatic Cancer	Ipsen	World except for the United States and Taiwan
ONIVYDE (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. *In combination with 5-FU/leucovorin Additional Information
ONIVYDE (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. *In combination with 5-FU/leucovorin Additional Information

Vorasidenib	IDH-mutant Low-Grade Glioma		World	Phase 3
PRIMARY INDICATION First line Low Grade Glioma		PARTNER		PARTNER World
PRIMARY INDICATION First line Low Grade Glioma PARTNER TERRITORY World
	First line Low Grade Glioma		World
The INDIGO Study is a Phase 3 clinical trial evaluating the safety and effectiveness of vorasidenib in people with Grade 2 low-grade gliomas with an IDH mutation.
The INDIGO Study is a Phase 3 clinical trial evaluating the safety and effectiveness of vorasidenib in people with Grade 2 low-grade gliomas with an IDH mutation.

Anti-PD-1, Anti-TIM3, Irinotecan Combo	Solid Tumors	Symphogen...	World	Phase 1
PRIMARY INDICATION Second Line Cholangiocarcinoma		PARTNER Symphogen is a subsidiary of Servier that serves as the antibody center of excellence. **		PARTNER World
PRIMARY INDICATION Second Line Cholangiocarcinoma PARTNER Symphogen is a subsidiary of Servier that serves as the antibody center of excellence. ** TERRITORY World
	Second Line Cholangiocarcinoma	Symphogen is a subsidiary of Servier that serves as the antibody center of excellence. **	World
*License option not yet exercised
*License option not yet exercised

Ivosidenib	Previously treated IDH1-mutant CCA		World except for China	Submitted
PRIMARY INDICATION Second line Cholangiocarcinoma with an IDH1-mutation		PARTNER		PARTNER World except for China
PRIMARY INDICATION Second line Cholangiocarcinoma with an IDH1-mutation PARTNER TERRITORY World except for China
	Second line Cholangiocarcinoma with an IDH1-mutation		World except for China
Ivosidenib was investigated in the ClarIDHy study, a global, randomized Phase 3 trial in previously treated IDH1 mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.
Ivosidenib was investigated in the ClarIDHy study, a global, randomized Phase 3 trial in previously treated IDH1 mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.

AG-270	MTAP-Deleted Pancreatic Cancer		World	Phase 1
PRIMARY INDICATION Metastatic Pancreatic Cancer		PARTNER		PARTNER World
PRIMARY INDICATION Metastatic Pancreatic Cancer PARTNER TERRITORY World
	Metastatic Pancreatic Cancer		World

Anti-Met	MTAP-Deleted NSCLC		Phase 2
PRIMARY INDICATION Non Small Cell Lung Cancer		PARTNER	PARTNER
PRIMARY INDICATION Non Small Cell Lung Cancer PARTNER TERRITORY
	Non Small Cell Lung Cancer

Anti-CD73	Various Solid Tumors		Phase 1
PRIMARY INDICATION Various Solid Tumors		PARTNER	PARTNER
PRIMARY INDICATION Various Solid Tumors PARTNER TERRITORY
	Various Solid Tumors

Oncology Pipeline

Research & Development

Our Pipeline

Hematological Malignancies

ONCASPAR®

(pegaspargase)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

ASPARLAS®

(calaspargase pegol-mknl)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

TIBSOVO®

(ivosidenib tablets)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

IDHIFA ®

(enasidenib)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

PIXURVI®

(pixantrone)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

MCL1 Inhibitor

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

BCL-2 Inhibitor

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

BCL- 2 Inhibitor

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

BCL-2 Inhibitor

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

BCL-2 Inhibitor

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

BCL-2 Inhibitor

ONCASPAR^®

ASPARLAS^®

PIXURVI^®