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		United States	Registered
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia		PARTNER		PARTNER United States
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia PARTNER TERRITORY United States
	First Line Acute Lymphoblastic Leukemia		United States
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

PIXUVRI^® (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
PIXUVRI is indicated for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-Cell Lymphoma. PIXURVI is not registered in the United States.
PIXUVRI is indicated for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-Cell Lymphoma. PIXURVI is not registered in the United States.

TIBSOVO^® (ivosidenib tablets)	IDH1-mutant IC-Ineligible Frontline AML		United States	Registered
PRIMARY INDICATION First Line Acute Myeloid Leukemia with IDH1 Mutation		PARTNER		PARTNER United States
PRIMARY INDICATION First Line Acute Myeloid Leukemia with IDH1 Mutation PARTNER TERRITORY United States
	First Line Acute Myeloid Leukemia with IDH1 Mutation		United States
TIBSOVO (ivosidenib tablets) in combination with azacitidine is indicated in the U.S. for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Additional Information
TIBSOVO (ivosidenib tablets) in combination with azacitidine is indicated in the U.S. for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Additional Information

TIBSOVO^® (ivosidenib tablets)	R/R IDH1-AML		United States	Registered
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia with a IDH1-mutation		PARTNER Acquired by Servier from Agios Pharmaceuticals in 2021		PARTNER United States
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia with a IDH1-mutation PARTNER Acquired by Servier from Agios Pharmaceuticals in 2021 TERRITORY United States
	Relapsed or Refractory Acute Myeloid Leukemia with a IDH1-mutation	Acquired by Servier from Agios Pharmaceuticals in 2021	United States
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

TIBSOVO^® (ivosidenib tablets)	IDH1-mutant IC-Ineligible Frontline AML		United States	Registered
PRIMARY INDICATION First Line Acute Myeloid Leukemia with IDH1 mutation (intensive chemotherapy ineligible)		PARTNER		PARTNER United States
PRIMARY INDICATION First Line Acute Myeloid Leukemia with IDH1 mutation (intensive chemotherapy ineligible) PARTNER TERRITORY United States
	First Line Acute Myeloid Leukemia with IDH1 mutation (intensive chemotherapy ineligible)		United States

Ivosidenib	IDH1-mutant IC-Eligible Frontline AML		World except for China	Phase 3
PRIMARY INDICATION First Line Intensive Chemotherapy-Eligible Acute Myeloid Leukemia		PARTNER		PARTNER World except for China
PRIMARY INDICATION First Line Intensive Chemotherapy-Eligible Acute Myeloid Leukemia PARTNER TERRITORY World except for China
	First Line 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

Pegaspargase	ALL		Phase 2
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia		PARTNER	PARTNER
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia PARTNER TERRITORY
	First Line Acute Lymphoblastic Leukemia

Calaspargase pegol-knl	ALL		World	Phase 2
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia (Patients ≥ 21 years old)		PARTNER		PARTNER World
PRIMARY INDICATION First Line Acute Lymphoblastic Leukemia (Patients ≥ 21 years old) PARTNER TERRITORY World
	First Line Acute Lymphoblastic Leukemia (Patients ≥ 21 years old)		World

UCART19	R/R ALL		Phase 2
PRIMARY INDICATION Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia		PARTNER Allogene	PARTNER
PRIMARY INDICATION Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia PARTNER Allogene TERRITORY
	Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia	Allogene

UCART19	R/R ALL		Phase 2
PRIMARY INDICATION Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia		PARTNER Allogene	PARTNER
PRIMARY INDICATION Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia PARTNER Allogene TERRITORY
	Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia	Allogene

Ivosidenib	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

BCL-2 Inhibitor	R/R AML + NHL + MM	Novartis/Vernalis	Phase 1
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia, Non-Hodgkin’s Lymphoma, Multiple Myeloma		PARTNER Novartis/Vernalis	PARTNER
PRIMARY INDICATION Relapsed or Refractory Acute Myeloid Leukemia, Non-Hodgkin’s Lymphoma, Multiple Myeloma PARTNER Novartis/Vernalis TERRITORY
	Relapsed or Refractory Acute Myeloid Leukemia, Non-Hodgkin’s Lymphoma, Multiple Myeloma	Novartis/Vernalis
In combination with MCL-1 Inhibitor
In combination with MCL-1 Inhibitor

BCL-2 Inhibitor		Phase 1
PRIMARY INDICATION	PARTNER	PARTNER
PRIMARY INDICATION PARTNER TERRITORY

In combination with HMA
In combination with HMA

MCL-1 Inhibitor	AML		Phase 1
PRIMARY INDICATION Acute Myeloid Leukemia		PARTNER	PARTNER
PRIMARY INDICATION Acute Myeloid Leukemia PARTNER TERRITORY
	Acute Myeloid Leukemia
In combination with venetoclax
In combination with venetoclax

MCL-1 Inhibitor	AML		Phase 1
PRIMARY INDICATION Acute Myeloid Leukemia		PARTNER	PARTNER
PRIMARY INDICATION Acute Myeloid Leukemia PARTNER TERRITORY
	Acute Myeloid Leukemia
In combination with azacitidine
In combination with azacitidine

Solid Tumors

Molecule Area	Primary Indication	Partner	Territory	Phase

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

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

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

TIBSOVO^® (ivosidenib tablets)	Previously treated IDH1-mutant CCA		United States	Registered
PRIMARY INDICATION Previously treated IDH1-mutated cholangiocarcinoma		PARTNER		PARTNER United States
PRIMARY INDICATION Previously treated IDH1-mutated cholangiocarcinoma PARTNER TERRITORY United States
	Previously treated IDH1-mutated cholangiocarcinoma		United States
TIBSOVO (ivosidenib tablets) is approved in the U.S. for previously treated IDH1-mutated cholangiocarcinoma.
TIBSOVO (ivosidenib tablets) is approved in the U.S. for previously treated IDH1-mutated cholangiocarcinoma.

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

Trifluridine/tipiracil	mCRC Third Line	Taiho Pharmaceutical Co.	World except for North America and Asia	Phase 3
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

Vorasidenib	IDH-mutant Low-Grade Glioma		World	Phase 3
PRIMARY INDICATION Residual or Recurrent Low-grade Glioma with IDH1/2 mutation		PARTNER		PARTNER World
PRIMARY INDICATION Residual or Recurrent Low-grade Glioma with IDH1/2 mutation PARTNER TERRITORY World
	Residual or Recurrent Low-grade Glioma with IDH1/2 mutation		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-MET	MTAP-Deleted NSCLC		World	Phase 2
PRIMARY INDICATION Non-Small Cell Lung Cancer		PARTNER		PARTNER World
PRIMARY INDICATION Non-Small Cell Lung Cancer PARTNER TERRITORY World
	Non-Small Cell Lung Cancer		World

Anti-LAG3	Solid Tumors		World	Phase 1
PRIMARY INDICATION Solid Tumors		PARTNER		PARTNER World
PRIMARY INDICATION Solid Tumors PARTNER TERRITORY World
	Solid Tumors		World

Anti-NKG2A	Metastatic Gastric or Colorectal Cancers		World	Phase 1
PRIMARY INDICATION Metastatic Gastric or Colorectal Cancers		PARTNER		PARTNER World
PRIMARY INDICATION Metastatic Gastric or Colorectal Cancers PARTNER TERRITORY World
	Metastatic Gastric or Colorectal Cancers		World

PD-L1x4-1BB	Solid Tumors		World except for the United States	Phase 1
PRIMARY INDICATION Solid Tumors		PARTNER		PARTNER World except for the United States
PRIMARY INDICATION Solid Tumors PARTNER TERRITORY World except for the United States
	Solid Tumors		World except for the United States

MAT2A	ESCC		World	Phase 1
PRIMARY INDICATION Esophageal Squamous Cell Carcinoma		PARTNER		PARTNER World
PRIMARY INDICATION Esophageal Squamous Cell Carcinoma PARTNER TERRITORY World
	Esophageal Squamous Cell Carcinoma		World

Anti-CD73	Various Solid Tumors		World	Phase 1
PRIMARY INDICATION High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies		PARTNER		PARTNER World
PRIMARY INDICATION High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies PARTNER TERRITORY World
	High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies		World

Anti-PD-1, Anti-TIM3, Irinotecan Combo	Solid Tumors	Symphogen...	World	Phase 1
PRIMARY INDICATION Second Line Biliary Tract Cancer and Esophageal Squamous Cell Carcinoma		PARTNER Symphogen is a subsidiary of Servier that serves as the antibody center of excellence. **		PARTNER World
PRIMARY INDICATION Second Line Biliary Tract Cancer and Esophageal Squamous Cell Carcinoma PARTNER Symphogen is a subsidiary of Servier that serves as the antibody center of excellence. ** TERRITORY World
	Second Line Biliary Tract Cancer and Esophageal Squamous Cell Carcinoma	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

Vorasidenib	IDH-mutant Grade 2-3 Glioma		World	Phase 1
PRIMARY INDICATION Grade 2-3 Glioma with IDH1/2 mutation		PARTNER		PARTNER World
PRIMARY INDICATION Grade 2-3 Glioma with IDH1/2 mutation PARTNER TERRITORY World
	Grade 2-3 Glioma with IDH1/2 mutation		World

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

PIXUVRI®

(pixantrone)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

TIBSOVO®

(ivosidenib tablets)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

TIBSOVO®

(ivosidenib tablets)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

TIBSOVO®

(ivosidenib tablets)

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

Ivosidenib

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

Pegaspargase

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

Calaspargase pegol-knl

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

UCART19

PRIMARY INDICATION

PARTNER

PARTNER

PRIMARY INDICATION

PARTNER

TERRITORY

ONCASPAR^®

ASPARLAS^®

PIXUVRI^®

TIBSOVO^®

TIBSOVO^®

TIBSOVO^®

LONSURF^®