On June 10, 2022 Imago BioSciences, Inc. ("Imago" or the "company") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with essential thrombocythemia (ET) (Press release, Imago BioSciences, JUN 10, 2022, View Source [SID1234615857]).

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The data were presented in a poster session during the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting and Congress (EHA) (Free EHA Whitepaper) taking place 9-12 June 2022. A Phase 2 data set with a cut-off of 1 November 2021 was previously presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021.

Updated Highlights (available data as of 29 April 2022):

Enrollment completed with 73 patients in April 2022
Of the 32 patients treated with bomedemstat for more than 24 weeks:
97% (31/32) achieved platelet count reduction to ≤400 x 109/L.
94% (30/32) achieved platelet count reduction to ≤400 x 109/L with no thromboembolic events, the primary efficacy endpoint of this study.
81% (26/32) of patients achieved a durable response, defined as platelet count of ≤400 x 109/L for at least 12 weeks.
Of the 31 patients with Total Symptom Score (TSS) data available at 24 weeks:
58% (18/31) showed a decrease in TSS.
32% (10/31) showed improvements ≥10 points, one component of the ELN criteria for response.
Importantly, platelet response rates were similar across all genotypes identified in the study (CALR, JAK2V617F, MPL and triple negative). Additionally, 67% (16/24) patients demonstrated a net decrease in mutation allele frequencies including both CALR and JAK2.
"I am genuinely thrilled with the results of our ongoing Phase 2 clinical study of bomedemstat in essential thrombocythemia (ET) that continues to support the tremendous potential of our drug candidate. Based on the most recent data cutoff for this Phase 2 trial, as monotherapy in patients with ET who have failed a standard-of-care treatment, bomedemstat demonstrated both favorable platelet and white count reduction and sustained durability of treatment effects," said Hugh Young Rienhoff, Jr. MD, CEO of Imago. "Having now completed, indeed exceeded, our target enrollment in the study, we remain on track for an End-of-Phase 2 meeting with the FDA later this year. Based on our clinical results to date and our productive interactions with regulatory authorities, we are excited about the upcoming Phase 3 registrational trial."

Safety & Tolerability

Bomedemstat was generally well-tolerated with no safety signals identified per the Safety Advisory Board.
The most common adverse events (AEs) (>20%) regardless of causality were dysgeusia (altered taste), fatigue, constipation, and arthralgia.
There were 19 reported serious adverse events (SAEs), 6 of which were deemed drug-related by the Investigator in 5% (3/67) of patients.
14 patients have discontinued treatment, with 10 due to AEs (1 death from aspiration pneumonia unrelated to bomedemstat), 2 due to withdrawal of consent, and 2 due to investigator decision.
Details on the Imago EHA (Free EHA Whitepaper) Presentation

Oral Presentation Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia (ET)
Session: 16. Myeloproliferative neoplasms – Clinical
Presenter: Francesca Palandri, M.D., Ph.D., Institute of Hematology "L. & A. Seràgnoli" Sant’Orsola-Malpighi University Hospital, Bologna, Italy
Date & Time: Friday, June 10, 2022, at 10:30 AM ET

For further details, please see the EHA (Free EHA Whitepaper) 2022 abstract and presentation on the Imago website here.

Virtual Investor Event Details

Individuals interested in listening to the event at 10:30 a.m. ET on Saturday, 11 June 2022 may do so by dialing (844) 348-6880 for domestic callers, or +1 (914) 800-3944 for international callers, and reference conference ID: 3493998; or from the webcast link in the investor relations section of the company’s website at: www.imagobio.com. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

About Imago’s Phase 2 Essential Thrombocythemia Program

Essential thrombocythemia (ET) is a rare blood cancer resulting in the overproduction of platelets which increases the risk of blood clots and bleeding. It is one of the myeloproliferative neoplasms (MPN) family of rare bone marrow diseases and affects approximately 80,000 – 100,000 patients in the U.S. Imago BioSciences is developing bomedemstat (IMG-7289), an orally administered LSD1 inhibitor, as a potential therapy for patients with ET.

This Phase 2 multi-center, open-label study was designed to assess the safety, efficacy, and pharmacodynamics of bomedemstat, an oral inhibitor of lysine-specific demethylase 1 (LSD1) (www.clinicaltrials.gov Identifier NCT04254978). Eligible patients aged 18 or older with ET who had failed at least one standard therapy and required treatment in order to lower their platelet count were considered for participation in this study. Exploratory assessments include the serial measurement of mutant allele frequencies and changing plasma cytokine profiles. The trial is being conducted in the United States, the United Kingdom, Europe, Hong Kong, New Zealand, and Australia. Imago announced first patient dosed on October 1, 2020. As of April 29, 2022, the trial completed enrollment with 73 participants.

On June 10, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported positive initial data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) (Press release, Cogent Biosciences, JUN 10, 2022, View Source [SID1234615856]). The data are being presented today in a poster presentation at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Vienna, Austria.

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"Advanced systemic mastocytosis is a severe, debilitating hematologic disorder and physicians and patients remain in search of more effective and better tolerated treatment options to fight this disease," said Daniel DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and APEX clinical trial investigator. "I am very impressed with the early, encouraging results presented today from the APEX study. If results like these can be shown in a larger set of patients with AdvSM, I believe bezuclastinib has the potential to help us take a big step forward in treating systemic mastocytosis patients."

"We are very excited to present initial clinical data from the APEX study of bezuclastinib in advanced systemic mastocytosis," said Andrew Robbins, Chief Executive Officer at Cogent Biosciences. "These results reinforce the hypothesis that a potent, selective KIT D816V inhibitor with limited CNS penetration has the potential to provide meaningful clinical activity to all systemic mastocytosis patients, without the tolerability challenges seen with other available treatment options. Based on these results, we expect to accelerate our timelines and investment and look forward to providing another APEX clinical update by the end of 2022, and to presenting SUMMIT clinical data in non-advanced systemic mastocytosis (NonAdvSM) patients in the first half of 2023."

Data from Ongoing Phase 2 APEX Clinical Trial
APEX is a global, open-label, multi-center, two-part Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. As of the data cutoff date of May 24, 2022, 11 patients had been treated in Part 1 at one of four dose levels (50 mg BID, 100 mg BID, 200 mg BID or 400 mg QD). The median age of patients at study entry was 70 years (ranging from 48-87 years). Patients were enrolled with the following sub-types: two patients with aggressive systemic mastocytosis (ASM), eight patients with systemic mastocytosis with associated hematologic neoplasm (SM-AHN), and one patient with mast cell leukemia (MCL). Two patients had received prior avapritinib and midostaurin treatment.

Initial Safety Data 
As of the cutoff date, May 24, 2022, bezuclastinib was generally well-tolerated at all doses. The majority of adverse events were Grade 1/2 and seen in no more than one patient with one serious adverse event and no Grade 4 events reported. Grade 3 events reported as at least possibly related were anemia (1 patient), neutropenia (1 patient) and hypersensitivity/mediator flare (1 patient). There were no reported cases of periorbital/peripheral edema, cognitive effects or intracranial bleeding events, which have been associated with other KIT inhibitors. As of the cutoff date, all patients remained on study. Subsequently, one SM-AHN patient with chronic myelomonocytic leukemia (CMML) transformed to acute myeloid leukemia (AML) and discontinued participation in the trial.

Initial Clinical Activity Data
As of the data cutoff date of May 24, 2022, all 11 patients treated were evaluated for signs of clinical activity. Eight of 11 patients had been treated for at least two cycles, had available data from bone marrow biopsy, and were evaluated for additional endpoints Cycle 3 Day 1 (C3D1) evaluable.

11/11 patients achieved ≥50% reduction in serum tryptase levels by central assessment
89% median reduction in serum tryptase
Six of these patients achieved reduction to <20 ng/mL
8/8 patients (C3D1 evaluable) achieved ≥50% reduction in bone marrow mast cells by central review
Six of these patients achieved complete clearance of bone marrow mast cell aggregates
8/8 patients (C3D1 evaluable) demonstrated decreases in KIT D816V variant allele fraction (VAF) by droplet digital polymerase chain reaction (ddPCR)
All patients remained on treatment with treatment duration ranging from 0.5 – 4.8 months
Two patients enrolled had previously received and discontinued avapritinib for toxicity reasons (intracranial hemorrhage, thrombocytopenia). Both patients have demonstrated clinical outcomes consistent with the avapritinib-naïve patients, including similar magnitude reductions in serum tryptase.

Bezuclastinib Clinical Development 
Based on the favorable initial safety and tolerability profile and clinical activity observed to date in the Phase 2 APEX clinical trial with bezuclastinib for AdvSM, Cogent will continue enrolling patients in Part 1 of APEX to determine a recommended dose for use in Part 2 of the trial. A pre-planned interim analysis is scheduled once approximately 28 patients have received at least two cycles of study treatment in Part 1. Cogent plans to present additional data from APEX by the end of 2022. In addition, Cogent continues to actively enroll patients in SUMMIT, a Phase 2 clinical trial with bezuclastinib for NonAdvSM, and PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST). Cogent plans to present initial data from SUMMIT and lead-in data from PEAK in the first half 2023.

Conference Call Information & EHA (Free EHA Whitepaper) poster
Cogent will host a webcast today at 8:00 am ET to discuss today’s APEX results. The webcast will be accessible through the Investors and Media section of Cogent’s website at View Source Following the live webcast, an archived replay will also be available.

The APEX poster to be presented at EHA (Free EHA Whitepaper) is available to registered conference attendees as well as on the Cogent Biosciences website in the Posters and Publications section of www.cogentbio.com/research.

On June 10, 2022 ChromaDex Corp. (NASDAQ:CDXC) ("the Company") a global bioscience company dedicated to healthy aging, reported a signed distribution agreement with Sinopharm Xingsha to accelerate cross-border sales of Tru Niagen into mainland China (Press release, ChromaDex, JUN 10, 2022, View Source [SID1234615855]). Tru Niagen features ChromaDex’s proprietary Niagen (patented nicotinamide riboside or NR) ingredient, which is the world’s most efficient NAD+ (nicotinamide adenine dinucleotide) precursor on the market, particularly over NMN (nicotinamide mononucleotide). Sinopharm Xingsha is the main platform of Sinopharm Group for food supplements and healthcare products and is a subsidiary of Sinopharm Group, with businesses including pharmaceutical manufacturing, marketing and distribution of drugs, and food supplements and healthcare products. Sinopharm Group is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission (SASAC) of the State Council, with a full value chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business, and financial services. In line with ChromaDex’s recent China Joint Venture announcement, Sinopharm Xingsha will collaborate to secure Health Food Registration in China.

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"We are delighted to announce the official launch of our partnership with Sinopharm Xingsha which will support accelerated cross-border sales of Tru Niagen across mainland China," said Rob Fried, CEO of ChromaDex. "China’s marketplace remains strategically important with more than 260 million people over the age of 60 and it is our intention to become the leading provider of NAD+ boosting supplements in the market."

According to a recently commissioned "Sizing the Market for NAD+ Supplements in China" report by Euromonitor, white space is considerable ― growing from a standing start in 2018 to annual NAD+ sales in excess of $700 million in 2021, with leading NMN brands each capturing approximately $30 to $50 million of retail sales. The report further estimates that NAD+ sales will reach in excess of $1.5 billion in 20241.

"ChromaDex is a global leader in the NAD+ supplement market, and Tru Niagen is a product endorsed by strong science," said Pan Lei, General Manager of Sinopharm Xingsha. "We are very honored to have this strategic cooperation with ChromaDex to jointly bring this excellent product to the Chinese consumers. Going forward, Sinopharm Xingsha will leverage its advantages and expertise in brand incubation, promotion, marketing, online and offline channel construction, registration of imported health supplements, etc., to offer a full range of services to support the brand promotion and sales channel development of Tru Niagen products in China."

Tru Niagen is currently available for sale to Chinese consumers on several cross-border online and marketplace platforms, primarily through T-mall, and JD. Under terms of the agreement, ChromaDex’s existing cross-border activity in this region will be transitioned to Sinopharm Xingsha in a coordinated effort to accelerate growth of Tru Niagen by leveraging Sinopharm’s established infrastructure, and marketing capabilities. The expansion of Tru Niagen will be supported by the introduction of a new premium Tru Niagen SKU, which will be launched in the future. Tru Niagen is also available in over 200 Watsons stores in Hong Kong and Macau, as well as over 100 Watsons stores in Singapore.

Tru Niagen, featuring Niagen, is one of the top-selling brands in the Vitamin B3 category on Amazon U.S. for boosting NAD+ levels. Supplementation with Niagen is backed by 20 published and peer-reviewed clinical trials. Niagen has achieved regulatory acceptance for use in supplements by the US FDA. Additionally, Niagen has been approved for use in food supplements by the European Commission, complementary medicines by the Therapeutic Goods Administration of Australia (TGA), medical foods by the Brazilian Health Regulatory Agency (ANVISA), and medical foods by the Food Standards Australia New Zealand (FSANZ). Tru Niagen has also been approved by Health Canada as a Natural Health Product. ChromaDex continues to lead the industry in NAD+ research, with the ChromaDex External Research Program (CERPTM) celebrating over 250 material transfer agreements (MTAs) featuring Niagen and other proprietary ingredients.

On June 10, 2022 ADC Therapeutics SA (NYSE: ADCT) reported that results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in relapsed or refractory (r/r) Hodgkin lymphoma (Press release, ADC Therapeutics, JUN 10, 2022, View Source [SID1234615854]). An overall response rate (ORR) of 70.1% and a complete response (CR) rate of 33.3% was observed with a median duration of response of 13.7 months for all responders in r/r Hodgkin lymphoma patients who were refractory or had relapsed after a median of 6 prior treatments, including brentuximab vedotin (BV) and a PD-1 blockade. The safety profile of Cami was substantially consistent with previously reported interim findings. The results will be presented today during an oral session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA2022).

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The Phase 2 single-arm, multicenter, open-label clinical trial is evaluating Cami in 117 patients with r/r Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT). Patients received a median of 6 prior lines of systemic therapy.

Data to be presented at EHA (Free EHA Whitepaper)2022 by Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital in Milan, Italy, include:

·ORR of 70.1% and CR rate of 33.3% in patients with a median of 6 prior treatments

·Median duration of response (DOR) was 13.7 months and median progression-free survival (PFS) was 9.1 months; patients who achieved a CR had a median DOR of 14.5 months

·14 patients received HSCT following treatment with Cami

·The most common grade ≥3 treatment-emergent adverse events in ≥5% of patients were: thrombocytopenia (9.4%), anemia (8.5%), hypophosphatemia (7.7%), neutropenia (7.7%), maculopapular rash (6.8%) and lymphopenia (5.1%)

·8/117 patients developed Guillain-Barré syndrome/polyradiculopathy. GBS symptoms could be mitigated with careful medical intervention.

In addition, the following three posters will be presented at EHA (Free EHA Whitepaper)2022 today from 16:30 – 17:45 CEST / 10:30 a.m. – 11:45 a.m. EDT in Hall D:

·Health-Related Quality Of Life And Tolerability Of Loncastuximab Tesirine In High-Risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated In A Phase 2 Clinical Trial (LOTIS 2)
Abstract Code: P1717

·Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Patients Who Received Car-T Therapy
Abstract Code: P1182

·Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Post Car-T Failure
Abstract Code: P1181

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

On June 10, 2022 AbbVie (NYSE: ABBV) reported new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor naïve patients with myelofibrosis (MF), a rare and difficult to treat blood cancer (Press release, AbbVie, JUN 10, 2022, View Source [SID1234615853]). These preliminary findings show spleen volume and symptomatic improvement in this cohort. These data are consistent with previously observed data from relapsed/refractory patients in Cohort 1a1 and will be shared in an oral presentation at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Abstract #S197).2

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REFINE is a Phase 2 non-randomized open-label multi-cohort study evaluating the safety and efficacy of navitoclax alone or in combination with ruxolitinib in MF.

"Current treatment options for myelofibrosis are limited and targeted toward controlling disease symptoms," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology clinical development, AbbVie. "Together with pre-clinical findings, early results of this study demonstrating anti-fibrosis activity of navitoclax in combination with ruxolitinib are promising. Specifically, the data findings regarding reduction in spleen volume, symptoms and bone marrow fibrosis help support the further exploration of disease modification in myelofibrosis."

The results presented at EHA (Free EHA Whitepaper) 2022 were from a preliminary analysis of 32 JAK inhibitor naïve MF patients from Cohort 3 of the Phase 2 REFINE trial (NCT03222609).2 The primary endpoint was spleen volume reduction of ≥35 percent (SVR35) from baseline at week 24.2 Key secondary endpoints include ≥50 percent reduction in total symptom score (TSS50) at week 24, anemia response and BMF reduction.2

In the results, SVR35 was achieved by 63 percent of evaluable patients at week 24 (20/32) and by 78 percent at any time on treatment (25/32).2 At week 24, 41 percent (11/27) of evaluable patients with measurable baseline symptoms reached TSS50; notably, 67 percent of patients (18/27) met this endpoint at any time during the study.2 In this cohort, 35 percent of evaluable patients, with available fibrosis grade at baseline and during the study, (9/26) achieved reduction in BMF by ≥1 grade at any time during the study with three patients experiencing ≥2 grade reductions in BMF.2 Additionally, 40 percent of patients evaluable for anemia response (6/15) experienced improvement in anemia, a common clinical feature of MF.2

Preliminary safety analysis identified no new safety signals. Thirty-one (97 percent) patients reported one or more adverse event (AE).1 The most common Grade ≥3 AEs were thrombocytopenia (47 percent), anemia (34 percent), and neutropenia (25 percent).1 Seven patients (22 percent) reported experiencing serious AEs.1 Three patients (9 percent) experienced an AE leading to navitoclax discontinuation and three patients (9 percent) reported an AE leading to ruxolitinib discontinuation.2

"These data reinforce the importance of early intervention in myelofibrosis and the potential to achieve improved clinical outcomes," said Francesco Passamonti, Full Professor of Hematology, University of Insubria and Chief, Hematology, Varee Hospital. "These preliminary results show good responses to combination therapy with navitoclax that may continue to improve over time."

About Navitoclax
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3

Navitoclax is not approved by the U.S. Food and Drug Administration (FDA) or any Health Authority worldwide at this time. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.

AbbVie has an extensive late-stage clinical trial program for investigational navitoclax that is currently enrolling. For more information about enrolling in a clinical trial, please visit us here.

About the REFINE Study
REFINE is a multi-cohort, Phase 2, randomized, open-label, multicenter study evaluating the tolerability and efficacy of navitoclax alone or when added to ruxolitinib in patients with myelofibrosis (MF).4 The primary outcome measure is the percentage of patients who achieve Spleen Volume Reduction of greater than or equal to 35 percent (SVR35) from baseline to Week 24. Secondary outcomes measures include percentage of participants achieving 50 percent reduction in Total Symptom Score from baseline to Week 24 and change in grade of bone marrow fibrosis assessed according to the European Consensus Grading System.

Data presented at EHA (Free EHA Whitepaper) 2022 include preliminary safety and efficacy results from Cohort 3 of REFINE (n=32). Patients in Cohort 3 had primary or secondary MF with splenomegaly and had not received JAK-2 therapy or BET inhibitors prior to enrollment. Data presented at EHA (Free EHA Whitepaper) 2022 are representative of data from Cohort 3 of the REFINE study as of February 7, 2022.

Data included in the official EHA (Free EHA Whitepaper) 2022 Abstract Book are representative of data from Cohort 3 of the REFINE study as of October 4, 2021.

More information can be found on View Source (NCT03222609).

About Myelofibrosis
Myelofibrosis (MF) is a rare, difficult-to-treat blood cancer that results in excessive scar tissue formation (fibrosis) in the bone marrow. Patients living with MF experience symptoms such as an enlarged spleen, fatigue, weakness, and severe anemia, that are often debilitating and greatly impact quality of life. MF also carries a risk of transformation to more aggressive disease such as acute myeloid leukemia.4

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit View Source