A Phase Ib/III Study to Evaluating the Efficacy and Safety of Parsaclisib in Combination With Rituximab and Lenalidomide Versus Rituximab in Combination With Lenalidomide in Subjects With Relapsed or Refractory Follicular Lymphoma

A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma

Start Date28 Jul 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT04796922 / WithdrawnPhase 3

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (MZL or FL) .

Start Date30 Dec 2022

Sponsor / Collaborator

Incyte Corp.

CTR20213340 / TerminatedPhase 3

一项在骨髓纤维化受试者中评价PI3Kδ抑制剂Parsaclisib联合芦可替尼的III期、随机、双盲、安慰剂对照研究

[Translation] A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Combined with Ruxolitinib in Subjects with Myelofibrosis

评价并比较parsaclisib+芦可替尼组与安慰剂+芦可替尼组在第24周的脾脏体积。

[Translation]

The spleen volume at week 24 was evaluated and compared between the parsaclisib + ruxolitinib group and the placebo + ruxolitinib group.

Start Date20 May 2022

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

[+2]

100 Clinical Results associated with Parsaclisib

100 Translational Medicine associated with Parsaclisib

100 Patents (Medical) associated with Parsaclisib

Literatures (Medical) associated with Parsaclisib

19 Dec 2023·Cancer research communications

Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Article

Author: Munster, Pamela ; Lakshminarayanan, Mani ; O'Day, Steven ; Bowman, Jill ; Kirkwood, John M ; Jones, Mark ; Villaruz, Liza C ; Mettu, Niharika B ; Gibney, Geoffrey T ; Cho, Daniel C ; Hodi, F Stephen ; Iannotti, Nicholas ; Smith, Michael

Abstract:

Purpose::

This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ inhibitor) in combination with pembrolizumab [programmed death-1 (PD-1) inhibitor].

Experimental Design::

Patients with advanced or metastatic solid tumors with disease progression following all available therapies were enrolled and received itacitinib (Part 1 initially 300 mg once daily) or parsaclisib (Part 1 initially 10 mg once daily; Part 2 all patients 0.3 mg once daily) plus pembrolizumab (200 mg every 3 weeks).

Results::

A total of 159 patients were enrolled in the study and treated with itacitinib (Part 1, n = 49) or parsaclisib (Part 1, n = 83; Part 2, n = 27) plus pembrolizumab. The maximum tolerated/pharmacologically active doses were itacitinib 300 mg once daily and parsaclisib 30 mg once daily. Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. Most common parsaclisib TRAEs were fatigue, nausea, diarrhea, and pyrexia in Part 1, and fatigue, maculopapular rash, diarrhea, nausea, and pruritus in Part 2. In patients receiving itacitinib plus pembrolizumab, four (8.2%) achieved a partial response (PR) in Part 1. Among patients receiving parsaclisib plus pembrolizumab, 5 (6.0%) achieved a complete response and 9 (10.8%) a PR in Part 1; 5 of 27 (18.5%) patients in Part 2 achieved a PR.

Conclusions::

Although combination of itacitinib or parsaclisib with pembrolizumab showed modest clinical activity in this study, the overall response rates observed did not support continued development in patients with solid tumors.

Significance::

PD-1 blockade combined with targeted therapies have demonstrated encouraging preclinical activity. In this phase I study, patients with advanced solid tumors treated with pembrolizumab (PD-1 inhibitor) and either itacitinib (JAK1 inhibitor) or parsaclisib (PI3Kδ inhibitor) experienced limited clinical activity beyond that expected with checkpoint inhibition alone and showed little effect on T-cell infiltration in the tumor. These results do not support continued development of these combinations.

01 Dec 2023·Hematological oncology

Safety and efficacy of parsaclisib in combination with obinutuzumab and bendamustine in patients with relapsed or refractory follicular lymphoma (CITADEL‐102): A phase 1 study

Article

Author: Langmuir, Peter ; Duras, Juraj ; Cordoba, Raul ; Zinzani, Pier Luigi ; Stouffs, Michael ; Liu, Huiqing ; Sancho, Juan-Manuel ; Boccia, Ralph ; Coleman, Morton ; Oreiro, Mariana Bastos ; Williams, Vanessa ; Hamadani, Mehdi ; Hutchings, Martin

Abstract:

Parsaclisib is a potent and highly selective PI3Kδ inhibitor that has shown clinical benefit with monotherapy in a phase 2 study in relapsed or refractory (R/R) follicular lymphoma (FL). CITADEL‐102 (NCT03039114), a phase 1, multicenter study, assessed the efficacy of parsaclisib in combination with obinutuzumab and bendamustine in patients with R/R FL. Patients were ≥18 years of age with histologically confirmed and documented CD20‐positive FL, and R/R to previous rituximab‐containing treatment regimens. Part one (safety run‐in) determined the maximum tolerated dose of parsaclisib in combination with standard dosage regimens of obinutuzumab and bendamustine. Part two (dose expansion) was an open‐label, single‐group design evaluating safety, tolerability (primary endpoint), and efficacy (secondary endpoint) of parsaclisib combination therapy. Twenty‐six patients were enrolled in CITADEL‐102 and all patients received parsaclisib 20 mg once daily for 8 weeks, followed by 20 mg once weekly thereafter, in combination with obinutuzumab and bendamustine. One patient in safety run‐in experienced a dose‐limiting toxicity of grade 4 QT interval prolongation that was considered related to parsaclisib. Eight patients (30.8%) discontinued treatment due to treatment‐emergent adverse events (TEAEs) of colitis (2 [7.7%]), alanine aminotransferase and aspartate aminotransferase increase (both in one patient [3.8%]), neutropenia, thrombocytopenia, QT prolongation, tonsil cancer, and maculopapular rash (each 1 [3.8%]). The most common reported TEAEs were pyrexia (53.8%), neutropenia (50.0%), and diarrhea (46.2%). Twenty‐three patients (88.5%) experienced grade 3 or 4 TEAEs; the most common were neutropenia (34.6%), febrile neutropenia (23.1%), and thrombocytopenia (19.2%). Seventeen patients (65.4%) had a complete response and 3 patients (11.5%) had a partial response, for an objective response rate of 76.9%. Overall, results from CITADEL‐102 suggest that the combination of parsaclisib with obinutuzumab and bendamustine did not result in unexpected safety events, with little evidence of synergistic toxicity, and demonstrated preliminary efficacy in patients with R/R FL who progressed following prior rituximab‐containing regimens.

01 Sep 2023·EClinicalMedicine

Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): a phase 2 study

Article

Author: Zheng, Fred ; Morley, Nicholas ; Wahlin, Björn E ; DeMarini, Douglas J ; Avigdor, Abraham ; McKinney, Matthew S ; Cunningham, David ; Canales, Miguel ; Devizzi, Liliana ; Jiang, Wei ; Belada, David ; Hrom, John S ; Jiang, Ping ; Lynch, Ryan C ; Trněný, Marek ; Paneesha, Shankara ; Bastos-Oreiro, Mariana

Background:

Parsaclisib, a potent and highly selective PI3Kδ inhibitor, has shown clinical benefit in patients with relapsed or refractory (R/R) B-cell malignancies. This phase 2 study (CITADEL-203; NCT03126019, EudraCT 2017-001624-22) assessed efficacy and safety of parsaclisib monotherapy in patients with R/R follicular lymphoma (FL).

Methods:

Patients ≥18 years of age with histologically confirmed R/R FL (grade 1-3a) and prior treatment with ≥2 systemic therapies received parsaclisib 20 mg once daily (QD) for 8 weeks then parsaclisib 20 mg once weekly (weekly dosing group [WG]) or parsaclisib 20 mg QD for 8 weeks then parsaclisib 2.5 mg QD (daily dosing group [DG]); DG was selected for further assessment. Primary endpoint was objective response rate (ORR).

Findings:

At data cut-off (January 15, 2021), 126 patients had been treated (WG: n = 23; DG: n = 103). ORR (95% confidence interval [CI]) was 77.7% (68.4-85.3) with a complete response rate (95% CI) of 19.4% (12.3-28.4) in DG; median (95% CI) duration of response was 14.7 months (10.4-not estimable [NE]), median progression-free survival was 15.8 months (11.0-NE), and median overall survival was not reached. The most common any-grade treatment-emergent adverse events (TEAEs) among all treated patients included diarrhoea (n = 48, 38.1%), nausea (n = 31, 24.6%), and cough (n = 28, 22.2%); the most common grade ≥3 TEAEs were diarrhoea (n = 15, 11.9%), neutropenia (n = 13, 10.3%), and colitis (n = 7, 5.6%). Dose interruption, reduction, and discontinuation from TEAEs occurred in 46.8% (n = 59), 17.5% (n = 22), and 23.8% (n = 30) of patients, respectively.

Interpretation:

Treatment with parsaclisib demonstrated rapid and durable responses, and a manageable safety profile in patients with R/R FL.

Funding:

Incyte Corporation.

News (Medical) associated with Parsaclisib

25 May 2023

·www.businesswire.com

Data from Across Incyte’s Oncology Portfolio Accepted for Presentation at the 2023 ASCO Annual Meeting and EHA2023 Hybrid Congress

WILMINGTON, Del.--( BUSINESS WIRE )--Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from across its oncology portfolio will be presented at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6 in Chicago, and at the European Hematology Association 2023 (EHA2023) Hybrid Congress held in Frankfurt, Germany, from June 8-11 and virtually from June 14-15. “Our presence at ASCO and EHA illustrates Incyte’s ongoing commitment to science that can lead to additional, needed solutions for patients with cancer,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “These data underscore the potential of our oncology pipeline, and highlight the variety of approaches we are exploring to advance research in areas where we believe we can have the greatest impact for patients.” Key abstracts accepted by ASCO and EHA include: ASCO Abstracts Abstracts are available to registered attendees on the ASCO Congress platform. Posters and slides will be available to registered attendees at the scheduled session start time. Poster Discussion LIMBER Phase 1/2 Study of the Activin Receptor-Like Kinase (ALK)-2 Inhibitor Zilurgisertib (INCB000928, LIMBER-104) as Monotherapy or with Ruxolitinib (RUX) in Patients (pts) with Anemia due to Myelofibrosis (MF) (Abstract #7017. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. Monday, June 5, 12:30 p.m. – 2:00 p.m. ET) Poster Presentations CK0804 Phase 1b, Open-Label Study of Add-On Therapy with CK0804 in Participants with Myelofibrosis, with Suboptimal Response to Ruxolitinib (Abstract #TPS7087. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. Monday, June 5, 9:00 a.m. – 12:00 p.m. ET) 1 Immuno-oncology (IO) A Phase 1/2 Study of Retifanlimab (INCMGA00012, Anti–PD-1), INCAGN02385 (Anti–LAG-3), and INCAGN02390 (Anti–TIM-3) Combination Therapy in Patients (Pts) with Advanced Solid Tumors (Abstract #2599. Session: Developmental Therapeutics—Immunotherapy. Saturday, June 3, 9:00 a.m. – 12:00 p.m. ET) Itacitinib Rates of Cytokine Release Syndrome (CRS) and Immune Effector Cell–Associated Neurotoxicity Syndrome (ICANS) from Center for International Blood and Marrow Transplant Research (CIBMTR) Data on U.S. Subjects (SUBJ) with Lymphoma Following Chimeric Antigen Receptor T Cell (CAR-T) Therapy (Abstract #7528. Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia. Monday, June 5, 9:00 a.m. – 12:00 p.m. ET) LIMBER Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 (LIMBER-103) in Patients (pts) with Relapsed or Refractory Myelofibrosis (R/R MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #7069. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. Monday, June 5, 9:00 a.m. – 12:00 p.m. ET) EHA Abstracts Abstracts are available on the EHA2023 Congress platform and accessible for on-demand viewing until August 15, 2023. Oral Presentations Ponatinib PhALLCON: A Phase 3 Study Comparing Ponatinib vs Imatinib in Newly Diagnosed Ph+ALL (Abstract #S110. Session: Immune Therapeutic Treatment in ALL. Friday, June 9, Date, 8:45 a.m. – 9:00 a.m. ET) 2 Ruxolitinib Ruxolitinib in Pediatric Patients with Treatment-Naive or Steroid Refractory Chronic Graft-Versus-Host Disease: Primary Findings from the Phase 2 REACH 5 Study (Abstract #S245. Session: SCT Clinical. Saturday, June 10, 5:30 a.m. – 6:45 a.m. ET) 3 Poster Presentations LIMBER Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 in Patients (pts) with Relapsed or Refractory Myelofibrosis (R/R-MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #P1055. Session: Myeloproliferative Neoplasms - Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) Phase 1/2 Study of the Activin Receptor-like Kinase 2 (ALK2) Inhibitor Zilurgisertib (INCB000928, LIMBER-104) as Monotherapy or with Ruxolitinib in Patients with Anemia due to Myelofibrosis (Abstract #P1022. Session: Myeloproliferative Neoplasms - Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) Parsaclisib A Phase 2, Multicenter, Single-Arm Study of Parsaclisib, a PI3Kδ Inhibitor, in Relapsed or Refractory Follicular Lymphoma in China: Updated Results from the Study (Abstract #P1099. Session: Indolent and Mantle-Cell Non-Hodgkin Lymphoma - Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) 4 Ponatinib Multicenter, Prospective and Retrospective Observational Cohort Study of Ponatinib in Patients with CML in Italy: Long-Term Follow-Up Results of the OITI Trial (Abstract #P663. Session: Chronic Myeloid Leukemia - Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) Early Cytogenetic or Molecular Landmark Response to Ponatinib Treatment Predicts Outcomes in Heavily Pretreated Patients with Chronic-Phase Chronic Myeloid Leukemia in PACE: 5-Year Data (Abstract #P670. Session: Chronic Myeloid Leukemia – Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) 3 Post Hoc Analysis of Patient Responses by T315I Mutation Status from the 3-Year Update of the OPTIC Trial: A Dose-Optimization Study of Three Starting Doses of Ponatinib (Abstract #P662. Session: Chronic Myeloid Leukemia – Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) 3 Ruxolitinib Characteristics and Clinical Outcomes in Patients (Pts) With Polycythemia Vera (PV) Receiving Ruxolitinib (RUX) after Hydroxyurea (HU): A Longitudinal Analysis from REVEAL (Abstract #P1032. Session: Myeloproliferative Neoplasms – Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) Disease Progression and Leukemic Transformation in Patients with Lower-Risk Myelofibrosis (MF): An Analysis from MOST (Abstract #P1045. Session: Myeloproliferative Neoplasms – Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) Treatment Comparison of Hydroxyurea vs Ruxolitinib in Essential Thrombocythemia (ET): A Matched Cohort Analysis (Abstract #P1046. Session: Myeloproliferative Neoplasms – Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) Tafasitamab Comprehensive Molecular Subtyping of Diffuse Large B-Cell Lymphoma Cell Lines and Association with Tafasitamab Activity (Abstract #P1227. Session: Lymphoma Biology & Translational Research. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) Five-Year Efficacy and Safety of Tafasitamab in Patients with Relapsed or Refractory DLBCL: Final Results from the Phase 2 L-MIND Study (Abstract #P1138. Session: Aggressive Non-Hodgkin Lymphoma – Clinical. Friday, June 9, 12:00 p.m. – 1:00 p.m. ET) 5 For full session details and data presentation listings, please see the ASCO ( https://conferences.asco.org ) and EHA2023 ( https://ehaweb.org/congress ) online programs. About Jakafi ® (ruxolitinib) Jakafi ® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi ® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States. About Iclusig ® (ponatinib) tablets Ponatinib (Iclusig ® ) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Tafasitamab (Monjuvi ® / Minjuvi ® ) Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In the United States, Monjuvi ® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe, Minjuvi ® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi ® monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Monjuvi ® and Minjuvi ® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI ® in the U.S., and marketed by Incyte under the brand name Minjuvi ® in Europe and Canada. XmAb ® is a registered trademark of Xencor, Inc. About Zynyz™ (retifanlimab-dlwr) Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a trademark of Incyte. About LIMBER Incyte is a leader in the discovery and development of therapies for patients with myeloproliferative neoplasms (MPNs) and graft-versus-host disease (GVHD). The LIMBER clinical trial program is designed to evaluate multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs and GVHD. These include ruxolitinib-based combinations with BET and ALK2, new therapeutic options including axatilimab and novel targets such as mutant CALR. About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte . Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions and Incyte’s goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; the effects of the COVID-19 pandemic and measures to address the pandemic on Incyte and its partners’ clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the U.S. FDA and other regulatory authorities outside of the United States; the efficacy or safety of Incyte and its partners’ products; the acceptance of Incyte and its partners’ products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended March 31, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements. ______________________________ 1 Cellenkos-sponsored abstract 2 Takeda-sponsored abstract 3 Novartis-sponsored abstract 4 Innovent-sponsored abstract 6 MorphoSys-sponsored abstract

Phase 2ImmunotherapyClinical ResultLicense out/inPhase 1

17 May 2023

·www.prnewswire.com

Innovent Announces Clinical Data of Multiple Trials Will be Presented at the 2023 ASCO and EHA Annual Meetings

ROCKVILLE, Md. and SUZHOU, China, May 16, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, today announces that about 30 accepted abstracts of clinical data from multiple trials in relation to TYVYT® (sintilimab injection), olverembatinib (BCR-ABL TKI), IBI326 (equecabtagene autoleucel), IBI376 (parsaclisib), IBI110 (anti-LAG-3 monoclonal antibody), IBI939 (anti-TIGIT monoclonal antibody) and IBI351 (KRASG12C inhibitor) will be presented at the upcoming international medical conferences. A brief summary of the selected presentations is as follows: AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING 2023 (Jun 2-6) Topic: PD-1 blockade with sintilimab plus induction chemotherapy and concurrent chemoradiotherapy (IC-CCRT) versus IC-CCRT in locoregionally-advanced nasopharyngeal carcinoma (LANPC): A multicenter, phase 3, randomized controlled trial (CONTINUUM).[1] Presentation Type: Oral Presentation Presentation Time ：June 5, 2023, 08:00 - 11:00 (GMT-5) Chicago, IL, U.S. Abstract Number: LBA 6002 Main Researcher: Professor Jun Ma and Professor Liu Xu, Department of Radiation Oncology, Sun Yat-sen University Cancer Center Topic: Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: Updated results from a phase 1b study Presentation Type: Poster Presentation Abstract Number: 2576 Main Researchers: Professor Nong Xu and Professor Chenyu Mao, The First Affiliated Hospital, School of Medicine, Zhejiang University. Topic: Efficacy and safety of IBI110 in combination with sintilimab in first-line of advanced hepatocellular carcinoma: preliminary results from a phase 1b study Presentation Type: Poster Presentation Abstract Number: 2577 Main Researcher: Professor Baocai Xing and Professor Ming Liu, Peking University Cancer Hospital & Institute. Topic: Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: preliminary results from a pooled analysis of two phase 1 studies Presentation Type: Poster Presentation Abstract Number: 3586 Main Researcher: Professor Ying Yuan and Professor Kefeng Ding, The Second Affiliated Hospital, Zhejiang University School of Medicine. Topic: CT103A, a novel fully human BCMA-targeting CAR-T therapy, in patients with relapsed/refractory multiple myeloma: updated long-term follow-up results of phase 1b/2 study (FUMANBA-1) Presentation Type: Poster Presentation Abstract Number: 8025 Main Researchers: Professor Chunrui Li, Department of Hematology, Tongji Hospital of Tongji Medical College, Huazhong University of Science; Professor Lugui Qiu, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Topic: Antitumor activity of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) Presentation Type: Poster Presentation Abstract Number: 11540 Main Researcher: Professor Haibo Qiu, Sun Yat-sen University Cancer Center. Topic: A study to evaluate the safety, tolerability and efficacy of IBI939 in combination with sintilimab in patients with previously untreated locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC): updated efficacy and safety results Presentation Type: Online Publication Abstract Number: e14578 Main Researcher: Professor Ying Cheng and Professor Chunjiao Wu, Jilin Cancer Hospital. EUROPEAN HEMATOLOGY ASSOCIATION (EHA) 2023 Hybrid Congress (Jun 8-15) Topic: CD47/PD-L1 bispecific antibody (IBI322) in anti-PD-1 or PD-L1 treatment-resistant classical Hodgkin lymphoma: a Phase 1 study Presentation Type: Oral Presentation Presentation Time: June 11, 2023, 11:30 - 12:45 (CEST) Frankfurt, Germany Abstract Number: S216 Main Researchers: Professor Ting Niu, West China Hospital of Sichuan University; Professor Huilai Zhang, Tianjin Medical University Cancer Institute & Hospital. Topic: A phase 2, multicenter, single-arm study of parsaclisib, a PI3kδ inhibitor, in relapsed or refractory follicular lymphoma in China: updated results from the study Presentation Type: Poster Presentation Abstract Number: P1099 Main Researcher: Professor Weili Zhao and Professor Zhong Zheng, Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Topic: Safety and efficacy of IBI346, a first-in-class BCMA-targeting modular CAR-T cell therapy, for patients with relapsed/refractory multiple myeloma (RR MM): preliminary results from two Phase 1 studies Presentation Type: Poster Presentation Abstract Number: P1406 Main Researcher: Professor Zhengzheng Fu and Professor Depei Wu, The First Affiliated Hospital of Soochow University; Professor Chunrui Li, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection), Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI), Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase 3 or pivotal clinical trials, and 18 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: . and . Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (Selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics

Phase 1ASCOPhase 2ImmunotherapyClinical Result

02 May 2023

·www.fiercebiotech.com

Incyte whittles down pipeline, scrapping 6 R&D programs

Incyte's pipeline cuts will allow the pharma to funnel resources to “programs that can have a high impact for patients and for Incyte," according to CEO Hervé Hoppenot. Incyte is whittling down its R&D pipeline, scrapping six discovery programs—one in a rare form of anemia and five in various cancers—to focus on eight remaining programs. The Jakafi maker’s remaining R&D programs “have high potential,” Incyte CEO Hervé Hoppenot said in a May 2 release. The pipeline trim will allow the pharma to funnel its resources to “programs that can have a high impact for patients and for Incyte." The company has ended phase 3 work on a small molecule PI3K inhibitor—known as parsaclisib—in warm autoimmune hemolytic anemia, citing the “challenging regulatory landscape associated with the PI3K class.” While several PI3K inhibitors have managed to snag FDA approval, the drug class has been frequently tied to serious or even fatal side effects. Last year, the FDA lost confidence in the safety profile of PI3K inhibitors for blood cancers after data from six randomized clinical trials indicated that four marketed PI3K inhibitors may shorten blood cancer patients’ life expectancy because of their toxicity. Since then, the agency said it would put the meds under a more stringent regulatory scope. Incyte’s parsaclisib had also been assessed in a phase 3 trial as a combo treatment alongside the pharma’s approved JAK inhibitor Jakafi for certain cancers. However, the pharma’s first effort at building a better Jakafi regimen ended in failure after an independent data monitoring committee found it was on course to miss the primary endpoint of reducing spleen volume in patients with bone marrow cancer myelofibrosis, and the study was discontinued. Incyte has also ended development of its adenosine program, which includes four separate assets. First on the list is INCB106385, which was being assessed in two separate phase 1 trials among patients with advanced solid tumors. One of those trials also evaluated INCA00186, which is being discontinued, alongside anti-GITR antibody INCAGN1876 in various cancers and INCB81776 in advanced malignancies. All the adenosine programs were discontinued based on early efficacy data, according to Incyte’s release. While Incyte continues to expand the reach of pemazyre—the first FDA-approved drug designed to specifically treat bile duct cancer—in non-U.S. countries, the pharma has ended a phase 2 clinical trial dubbed FIGHT-210 that was testing out the drug in non-small cell lung cancer. So what remains? One of the eight programs the company is zooming in on is INCB123667, a CDK2 inhibitor being studied in a phase 1 trial for patients with advanced malignancies. Another of the surviving programs is INCA33890, a bispecific antibody that has shown anti-tumor effects in preclinical studies. Alongside other discovery programs, Incyte continues to work to expand labels for its approved drugs. Despite the R&D overhaul, the drug developer still seems to be investing in new science for its pipeline. Last month, Incyte paid out $7 million cash to use Biotheryx’s platform to identify and initially develop molecular glue degraders for “multiple historically undruggable oncology targets.” The deal gives Biotheryx the chance to make another $6 million in R&D funding and up to $347 million in milestone payments.

Phase 1Phase 2Drug ApprovalPhase 3Clinical Trial Termination

100 Deals associated with Parsaclisib

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KEGG	Wiki	ATC	Drug Bank
D11437	-	-	DB14867

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Follicular Lymphoma	NDA/BLA	CN	Incyte Corp.	06 Jan 2023
Recurrent Follicular Lymphoma	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	06 Jan 2023
Recurrent Follicular Lymphoma	NDA/BLA	CN	Quotient Sciences Ltd.	06 Jan 2023
Refractory Follicular Lymphoma	NDA/BLA	CN	Incyte Corp.	06 Jan 2023
Refractory Follicular Lymphoma	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	06 Jan 2023
Refractory Follicular Lymphoma	NDA/BLA	CN	Quotient Sciences Ltd.	06 Jan 2023
Follicular Lymphoma	NDA/BLA	US	Incyte Corp.	01 Nov 2021
Mantle-Cell Lymphoma	NDA/BLA	US	Incyte Corp.	01 Nov 2021
Marginal Zone B-Cell Lymphoma	NDA/BLA	US	Incyte Corp.	01 Nov 2021
Autoimmune Haemolytic Anaemias	Phase 3	US	Incyte Corp.	15 Mar 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02718300 (Pubmed)	Phase 2	Myelofibrosis Add-on	-	Parsaclisib 10 or 20 mg, once daily for 8 weeks, and once weekly thereafter	ogozqjvtjv(weshyoefhp) = 19% cjaqskjguk (twupafnxsc ) View more	-	26 Mar 2024
				Parsaclisib 5 or 20 mg, once daily for 8 weeks, then 5 mg once daily thereafter
NCT04434937 (CTgov)	Phase 2	Refractory Follicular Lymphoma	42	Parsaclisib	afpqrkiqrj(tlojbleutn) = fhjrqkeuut eyesvxdfcs (azpeewefrr, kwqxtxrmyn - tkqfjdlnhv) View more	-	03 Jan 2024
NCT02646748 (Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm	159	Itacitinib	vwqpatdkeu(jrordvpvar) = Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. gtlwutkmuj (fmdlrantrq ) View more	Negative	19 Dec 2023
				Parsaclisib
NCT04298879 (EHA2023)	Phase 2	Refractory Follicular Lymphoma	61	Parsaclisib 20 mg	rnajpaeqde(rbcxwbnafu) = lqfiwtjyky iidmtqhomy (obrlbqseka, 82.7 - 97.6) View more	-	08 Jun 2023
NCT03538041 (CTgov)	Phase 2	Autoimmune Haemolytic Anaemias	25	Parsaclisib (Parsaclisib 1 mg QD)	jprmbtfhor(gxzuwzyuhb) = tglevcjzpu uqddcpsyfn (nafvaupzjs, ukvqnhwdxj - zikllwtrxn) View more	-	22 Sep 2022
				Parsaclisib (Parsaclisib 2.5 mg QD)	jprmbtfhor(gxzuwzyuhb) = vrwybwwryw uqddcpsyfn (nafvaupzjs, wmrpczqnjr - rxoffkfncv) View more
NCT02718300 (INCB 50465-201, AACR2022) Manual	Phase 2	Primary Myelofibrosis	67	parsaclisib+ruxolitinib (low PC)	vgxluknhdy(pdwyfzfpif) = hrttxkjutd kpxreawgqg (bkydflgkkq ) View more	Positive	15 Jun 2022
				parsaclisib+ruxolitinib (higher PC)	vgxluknhdy(pdwyfzfpif) = ghppwguftp kpxreawgqg (bkydflgkkq ) View more
NCT04298879 (ASCO2022)	Phase 2	Refractory Follicular Lymphoma	61	Parsaclisib 20 mg QD followed by 2.5 mg QD	kjzrskxwtr(zpodqlvfsj) = fexolgsyak itfasmwzoc (kudzhovtdx, 75.8 - 94.2) View more	Positive	02 Jun 2022
NCT03039114 (CITADEL-102, EHA2022) Manual	Phase 1	Follicular Lymphoma CD20 Positive	26	Parsaclisib+Bendamustine Hydrochloride+Obinutuzumab	dsudqjmmnf(rkeryaieya) = rjekfmstnx yhbvvwforv (xyuplzxgzb ) View more	Positive	12 May 2022
NCT02718300 (INCB 50465-201, EHA2022)	Phase 2	Primary Myelofibrosis Add-on	67	Parsaclisib-ruxolitinib combination therapy	jxhkvfzrpb(ufelfwerbz) = orikfgiqsb deljzyaowy (obfvengvbz )	-	12 May 2022
NCT03424122 (CITADEL-112, EHA2022)	Phase 1	B-Cell Lymphoma	50	Parsaclisib + Rituximab	rupdagtltc(caxzmhpzbf) = TEAEs with fatal outcome were reported in 2 pts in Tmt A (COVID-19 and COVID-19 pneumonia [n = 1]), and 1 pt in Tmt C (COVID-19, acute kidney injury) fgygakudwx (bmudwktvmb ) View more	-	12 May 2022
				Parsaclisib + Rituximab + Bendamustine

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