On May 11, 2023 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported its financial and operating results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Chemomab, MAY 11, 2023, View Source [SID1234631495]).

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"I am pleased to report that we have continued to make good progress on multiple fronts since our last quarterly update," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "In January we reported encouraging top-line results from our CM-101 Phase 2 liver fibrosis trial in nonalcoholic steatohepatitis (NASH) patients. In this study CM-101 appeared safe and demonstrated improvement across multiple disease-related fibrotic and inflammatory biomarkers. In our view, these data have been generally well-received by opinion leaders and potential partners. Importantly, these results also are consistent with the encouraging biomarker changes that were observed in two earlier CM-101 clinical trials and reinforce our optimism about CM-101’s potential as a treatment for fibro-inflammatory diseases."

Dr. Pfost continued, "We continue to make good progress in advancing our CM-101 Phase 2 clinical program in primary sclerosing cholangitis (PSC). We have opened additional clinical sites, added an open label extension and enhanced our patient outreach activities, supporting our goal of reporting top-line data in the second half of next year."

"Turning to systemic sclerosis (SSc), earlier this year we reported that our Investigational New Drug (IND) submission for our CM-101 Phase 2 trial was cleared by the FDA. We have been working diligently to prepare for the start of this proof-of-concept trial and we are on track to open our initial U.S. sites around mid-year. We expect to report data from this trial in the latter part of 2024. We also are supporting our clinical programs with an active schedule of scientific presentations at major medical meetings in the U.S. and Europe, and we anticipate several scientific publications in respected journals going forward. These activities aim to build knowledge about, and interest in, our unique approach to fibro-inflammatory diseases among researchers and opinion leaders."

"Since our last call, we have also added two exceptional senior executives—our Chief Medical Officer, Dr. Matt Frankel, and our Vice President of Corporate Development and Strategy, Dr. Mitch Jones. Matt brings us a wealth of global clinical and medical affairs experience, along with his track record in helping to bring numerous drugs to market. Mitch is an MD/PhD with a rich combination of science and business skills that make him uniquely well qualified to lead the corporate development function at Chemomab."

"I am also pleased to announce that today we are extending our estimated cash runway by another quarter through the first half of 2024," said Dr. Pfost. "We accomplished this extension while maintaining the resources needed to advance our two clinical programs towards our expected data read-outs in the second half of 2024. In conclusion, we believe that CM-101 has the potential to make a difference in deadly diseases with few current treatment options and we are committed to staying laser-focused on assessing its potential."

Clinical Update

Reported Top-line Results from CM-101 Phase 2 Liver Fibrosis Trial in NASH Patients

Top-line results were reported in January demonstrating that CM-101 met its primary endpoint of safety and tolerability and showed positive activity across multiple liver fibrosis biomarkers and physiologic assessments. These results provide insights supporting the overall CM-101 clinical development program as well as pharmacokinetic and tolerability data needed to inform next steps in the development of the current subcutaneous formulation of CM-101.

Advanced Phase 2 Trial in PSC Patients

Late last year, the independent Drug Monitoring Committee for the PSC trial reviewed CM-101 safety data and cleared the addition of a planned higher dose arm to the trial. In recent months Chemomab has opened additional clinical trial sites and implemented a protocol amendment adding the higher dose cohort and an open label extension. Currently Chemomab believes it is on track to report top-line data from the double-blind portion of this trial in the second half of 2024.

Received FDA IND Clearance for CM-101 Phase 2 Trial in SSc Patients

Following the recent IND clearance, Chemomab is finalizing plans to open the Phase 2 SSc trial to patient enrollment by mid-year. The study will be conducted at multiple sites in the U.S., Europe and Israel. It aims to confirm the critical role of CCL24 in SSc and to establish biological and clinical proof-of-concept for CM-101 in patients with SSc. The study is designed to generate additional information about disease mechanisms and to enable more informed decisions about future patient stratification strategies and the selection of endpoints for registrational studies. An initial data read-out is planned for the second half of 2024.

First Quarter 2023 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $32.8 million as of March 31, 2023, compared to $39.9 million at December 31, 2022.
Research and Development (R&D) Expenses: R&D expenses were $6.9 million for the quarter ended March 31, 2023, compared to $2.7 million for the same quarter in 2022. The increase was primarily due to increased clinical and preclinical activities.
General and Administrative (G&A) Expenses: G&A expenses were $2.2 million for the quarter ended March 31, 2023, compared to $2.6 million for the same quarter in 2022.
Net Loss: Net loss was $8.8 million, or a net loss of approximately $0.04 per basic and diluted ordinary share for the first quarter of 2023, compared to $5.1 million, or a net loss of approximately $0.02 per basic and diluted ordinary share for the quarter ended March 31, 2022. The weighted average number of ordinary shares outstanding, basic and diluted, was 220,996,240 (equal to approximately 11 million ADSs) for the quarter ended March 31, 2023.
For further details on the company’s financial results for the quarter ended March 31, 2023, please refer to the company’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission today.

Conference Call and Webcast

Chemomab management will host a conference call for investors today, Thursday, May 11, 2023, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions.

Click this Webcast link to access the live webcast or replay. The live webcast and replay can also be accessed at the News & Events section of the Investors page on the Chemomab website at investors.chemomab.com/events.

To access the conference call via telephone, shareholders and other interested parties can dial
+1 (877) 407-9208 (in the U.S.) or +1 (201) 493-6784 (outside the U.S., including Israel) and enter passcode 3735393. Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call.

Or click on Call meTM starting 15 minutes before the scheduled start time for instant telephone access without having to wait for an operator.

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.

On May 11, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the first quarter of 2023 (Press release, Charles River Laboratories, MAY 11, 2023, View Source [SID1234631494]). For the quarter, revenue was $1.03 billion, an increase of 12.6% from $913.9 million in the first quarter of 2022.

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Acquisitions contributed 1.8% to consolidated first-quarter revenue growth, and the divestiture of the Avian Vaccine business in December 2022 reduced reported revenue growth by 2.5%. The impact of foreign currency translation reduced reported revenue growth by 2.1%. Excluding the effect of these items, organic revenue growth of 15.4% was driven by the Discovery and Safety Assessment (DSA) and Research Models and Services (RMS) business segments.

On a GAAP basis, first-quarter net income attributable to common shareholders was $103.1 million, an increase of 10.9% from $93.0 million for the same period in 2022. First-quarter diluted earnings per share on a GAAP basis were $2.01, an increase of 11.0% from $1.81 for the first quarter of 2022. GAAP earnings per share included a loss from the Company’s venture capital and other strategic investments of $0.03 per share in the first quarter of 2023, compared to a loss of $0.20 per share for the same period in 2022. The Company’s venture capital and other strategic investment performance has been excluded from non-GAAP results.

On a non-GAAP basis, net income was $143.0 million for the first quarter of 2023, an increase of 1.3% from $141.1 million for the same period in 2022. First-quarter diluted earnings per share on a non-GAAP basis were $2.78, an increase of 1.1% from $2.75 per share for the first quarter of 2022.

The GAAP and non-GAAP net income and earnings per share increases were primarily driven by higher revenue and operating income, partially offset by increased interest expense and a higher tax rate, as well as the impact of the Avian Vaccine divestiture.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We had a strong start to the year with a continuation of the healthy demand and pricing environment in our DSA segment, resulting in better-than-expected first quarter results. We believe that our clients have the funding to move their promising drug candidates forward, and the strength of our backlog continues to support more than one year of DSA revenue. Based on changing macroeconomic factors and following the unprecedented level of biomedical research activity that occurred over the past several years, demand trends are normalizing towards pre-pandemic levels. However, these trends, when balanced with our strong first-quarter financial performance, continue to give us confidence in our financial guidance for 2023."

First-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $199.8 million in the first quarter of 2023, an increase of 13.2% from $176.5 million in the first quarter of 2022. The Explora BioLabs acquisition contributed 8.9% to RMS revenue growth, and the impact of foreign currency translation reduced revenue by 2.5% in the quarter. Organic revenue growth of 6.8% was primarily driven by broad-based growth for small research models, research model services, and the Cell Solutions business.

In the first quarter of 2023, the RMS segment’s GAAP operating margin decreased to 20.2% from 27.1% in the first quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 23.4% from 29.9%. The GAAP and non-GAAP operating margin decreases were driven primarily by the timing of large model shipments in China, as well as the segment’s overall revenue mix.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $662.4 million in the first quarter of 2023, an increase of 21.7% from $544.3 million in the first quarter of 2022. The impact of foreign currency translation reduced revenue by 2.1%, and the SAMDI Tech acquisition contributed 0.2% to reported DSA revenue growth in the quarter. Organic revenue growth of 23.6% was driven principally by broad-based growth in the Safety Assessment business, resulting from higher study volume and meaningful price increases.

In the first quarter of 2023, the DSA segment’s GAAP operating margin increased to 25.9% from 19.3% in the first quarter of 2022, and on a non-GAAP basis, the operating margin increased to 29.0% from 22.9%. The GAAP and non-GAAP operating margin increases were driven by operating leverage from higher revenue in the Safety Assessment business.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $167.3 million in the first quarter of 2023, a decrease of 13.4% from $193.1 million in the first quarter of 2022. The impact of the Avian Vaccine divestiture reduced revenue by 9.7%, and the impact of foreign currency translation reduced revenue by 1.9%. The decrease of 1.8% in organic revenue for the quarter was driven primarily by lower revenue in the CDMO business, which faced a challenging year-over-year comparison due to commercial readiness milestones in the first quarter of last year, and the Biologics Testing Solutions business, which experienced lower-than-anticipated testing volumes at the beginning of the year and a difficult comparison associated with last year’s COVID-related testing revenue. These factors were partially offset by revenue growth in the Microbial Solutions business.

In the first quarter of 2023, the Manufacturing segment’s GAAP operating margin decreased to 1.3% from 24.0% in the first quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 13.7% from 33.1% in the first quarter of 2022. The GAAP and non-GAAP operating margin declines were the result of lower operating margins in each of the segment’s business units, particularly the CDMO and Biologics Testing Solutions businesses.

Updates 2023 Guidance

The Company is updating its 2023 financial guidance, which was initially provided on February 22, 2023. The Company is narrowing its revenue growth and earnings per share outlooks to reflect the strong first-quarter financial performance and expectations for the remainder of the year that are largely consistent with its initial outlook. This outlook continues to reflect the anticipated impact of Cambodian NHP supply constraints, which is expected to affect the Company’s financial results principally in the second half of the year.

The Company’s 2023 guidance for revenue growth and earnings per share is as follows:

2023 GUIDANCE

CURRENT

PRIOR

Revenue growth, reported

2.0% – 4.5%

1.5% – 4.5%

Impact of divestitures/(acquisitions), net

~1.5%

~1.5%

Impact of 53rd week in 2022

~1.5%

~1.5%

Unfavorable/(favorable) impact of foreign exchange

0.0% – (0.5)%

0.0% – (0.5)%

Revenue growth, organic (1)

5.0% – 7.5%

4.5% – 7.5%

GAAP EPS estimate

$7.45 – $8.45

$7.40 – $8.60

Acquisition-related amortization

~$2.00

~$2.00

Acquisition and integration-related adjustments (2)

~$0.10

~$0.10

Venture capital and other strategic investment losses/(gains), net (3)

$0.03

—

Other items (4)

$0.30 – $0.35

~$0.20

Non-GAAP EPS estimate

$9.90 – $10.90

$9.70 – $10.90

Footnotes to Guidance Table:
(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures, the 53rd week in 2022, and foreign currency translation.
(2) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, certain third-party integration costs, and certain costs associated with acquisition-related efficiency initiatives.
(3) Venture capital and other strategic investment performance only includes recognized gains or losses. The Company does not forecast the future performance of these investments.
(4) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; certain third-party legal costs related to (a) environmental litigation related to the Microbial Solutions business and (b) investigations by the U.S. government into the NHP supply chain related to our Safety Assessment business; and severance and other costs related to the Company’s efficiency initiatives.
Webcast

Charles River has scheduled a live webcast on Thursday, May 11th, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Non-GAAP Reconciliations

The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, such as non-GAAP earnings per diluted share, non-GAAP operating income, non-GAAP operating margin, and non-GAAP net income. Non-GAAP financial measures exclude, but are not limited to, the amortization of intangible assets, and other charges and adjustments related to our acquisitions and divestitures, including the gain on our sale of our Avian Vaccine business; expenses associated with evaluating and integrating acquisitions and divestitures, including advisory fees and certain other transaction-related costs, as well as fair value adjustments associated with contingent consideration; charges, gains, and losses attributable to businesses or properties we plan to close, consolidate, or divest; severance and other costs associated with our efficiency initiatives; the write-off of deferred financing costs and fees related to debt financing; investment gains or losses associated with our venture capital and other strategic equity investments; certain legal costs in our Microbial Solutions business related to environmental litigation and in our Safety Assessment business related to U.S. government investigations into the NHP supply chain; and adjustments related to the recognition of deferred tax assets expected to be utilized as a result of changes to the our international financing structure and the revaluation of deferred tax liabilities as a result of foreign tax legislation. This press release also refers to our revenue on both a GAAP and non-GAAP basis: "organic revenue growth," which we define as reported revenue growth adjusted for foreign currency translation, acquisitions, divestitures, and the impact of the 53rd week in 2022. We exclude these items from the non-GAAP financial measures because they are outside our normal operations. There are limitations in using non-GAAP financial measures, as they are not presented in accordance with generally accepted accounting principles, and may be different than non-GAAP financial measures used by other companies. In particular, we believe that the inclusion of supplementary non-GAAP financial measures in this press release helps investors to gain a meaningful understanding of our core operating results and future prospects without the effect of these often-one-time charges, and is consistent with how management measures and forecasts the Company’s performance, especially when comparing such results to prior periods or forecasts. We believe that the financial impact of our acquisitions and divestitures (and in certain cases, the evaluation of such acquisitions and divestitures, whether or not ultimately consummated) is often large relative to our overall financial performance, which can adversely affect the comparability of our results on a period-to-period basis. In addition, certain activities and their underlying associated costs, such as business acquisitions, generally occur periodically but on an unpredictable basis. We calculate non-GAAP integration costs to include third-party integration costs incurred post-acquisition. Presenting revenue on an organic basis allows investors to measure our revenue growth exclusive of acquisitions, divestitures, the 53rd week in 2022, and foreign currency exchange fluctuations more clearly. Non-GAAP results also allow investors to compare the Company’s operations against the financial results of other companies in the industry who similarly provide non-GAAP results. The non-GAAP financial measures included in this press release are not meant to be considered superior to or a substitute for results of operations presented in accordance with GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules and regulations. Reconciliations of the non-GAAP financial measures used in this press release to the most directly comparable GAAP financial measures are set forth in this press release, and can also be found on the Company’s website at ir.criver.com.

On May 11, 2023 Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the first quarter ended March 31, 2023 (Press release, Century Therapeutics, MAY 11, 2023, View Source [SID1234631493]).

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"We are keenly focused on advancing our next generation iNK and gamma delta iT platforms to deliver transformative allogeneic cell therapies to patients with unmet need," said Greg Russotti, Ph.D., interim Chief Executive Officer, Century Therapeutics. "For our lead candidate, CNTY-101, we remain on track to report initial data from Schedule A of the ongoing Phase 1 ELiPSE-1 trial in patients with relapsed or refractory CD19 positive B-cell lymphomas by year end. With a strong balance sheet expected to support operations into 2026 and a highly talented team, we believe we are well positioned to successfully execute on our mission."

Business Highlights & Upcoming Milestones

· At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, the Company presented preclinical data from its iPSC-based cell therapy platform supporting the selection of CNTY-101 as its lead product candidate. Additional preclinical data characterizing epigenetic and transcriptomic donor-specific differences iNK cells were also shared. A copy of each poster is available in the "Science" section of the Company’s website at View Source

· In March 2023, the Company announced the appointment of Greg Russotti, Ph.D., as interim Chief Executive Officer. Dr. Russotti, who served as the Company’s Chief Technology Officer since January 2020, succeeds Lalo Flores, Ph.D., who stepped down as Chief Executive Officer and as a member of the Company’s Board of Directors. In addition, Michael C. Diem, M.D., was promoted to the role of Chief Financial Officer and Hy Levitsky, M.D., assumed his prior role as President of Research and Development.

· The first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas is ongoing. The Company remains on track to report preliminary data from Schedule A of the trial, including pharmacokinetics, pharmacodynamics, and safety, by year end.

· At the upcoming American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Company will present a Trials in Progress poster related to its Phase 1 ELiPSE-1 trial. A copy of the poster, titled, "The ELiPSE-1 Study: A Phase 1 Multicenter Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B Cell Malignancies", will be made available on the Posters section of Century’s website following the presentation.

First Quarter 2023 Financial Results

· Cash Position: Cash, cash equivalents, and marketable securities were $334.8 million as of March 31, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $29.2 million for the three months ended March 31, 2023, compared to net cash provided by operations of $86.8 million for the three months ended March 31, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $122.1 million).

· Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option and license agreement with Bristol-Myers Squibb was $1.7 million for the three months ended March 31, 2023, compared to $1.1 million for the same period in 2022.

· Research and Development (R&D) expenses: R&D expenses were $24.9 million for the three months ended March 31, 2023, compared to $21.2 million for the same period in 2022. The increase in R&D expenses was primarily due to an increase in personnel expenses related to the reduction in force in January of 2023, costs for preclinical studies and clinical expenses for advancing CNTY-101, and facility costs.

· General and Administrative (G&A) expenses: G&A expenses were $8.9 million for the three months ended March 31, 2023, compared to $7.3 million for the same period in 2022. The increase in G&A expenses was primarily due to an increase in personnel-related expenses to build our infrastructure, as well as increased information technology and facility costs.

· Net loss: Net loss was $31.3 million for the three months ended March 31, 2023, compared to $37.5 million for the three months ended March 31, 2022.

Financial Guidance

· The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $135 million and $145 million, including non-cash stock-based compensation expense of $12 million to $17 million.

· The Company estimates its cash, cash equivalents, and investments will support operations into 2026.

On May 11, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported the release of an abstract, which was accepted for presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress, taking place on June 8-15, 2023 in Frankfurt, Germany (Press release, Cellectis, MAY 11, 2023, View Source [SID1234631492]).

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Cellectis will present, in a poster session, updated clinical and translational data on its BALLI-01 clinical trial (evaluating UCART22) in patients with relapsed/refractory B-cell acute lymphoblastic Leukemia (r/r B-ALL).

"Cellectis is excited to present updated clinical and translational data from its BALLI-01 clinical trial (evaluating UCART22) in patients with relapsed/refractory B-cell acute lymphoblastic leukemia. These data are very encouraging for patients who have limited, if any, treatment options, especially for those who have failed prior CD19 directed CAR T-cell therapy and allogeneic stem cell transplant" said Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis.

Poster Presentation:

BALLI-01 investigation UCART22 product candidate in r/r B-ALL

The abstract includes preliminary clinical data from the Phase 1/2a, open label dose-escalation BALLI-01, in patients with r/r B-ALL having received UCART22 following lymphodepletion (LD) with either fludarabine, cyclophosphamide (FC) or FC with alemtuzumab (FCA).

The data show that UCART22 was well tolerated and clinical responses were achieved. UCART22 continues to have a good safety profile, with no serious treatment emergent adverse events (TEAEs) or DLTs reported. Overall, these data support the safety and preliminary efficacy of UCART22 in a heavily pretreated r/r B-ALL population.

UCART22 is a genetically modified allogeneic T-cell product manufactured from healthy donor cells. Donor-derived T-cells are transduced using a lentiviral vector to express the anti-CD22 chimeric antigen receptor (CAR) and are further modified using Cellectis’ TALEN technology to disrupt the T-cell receptor alpha constant (TRAC) and CD52 genes to minimize risk of graft-vs-host disease (GvHD) and allow use of an anti-CD52 antibody for lymphodepletion (LD).

Presentation Details:

Title: Updated Results of the Phase I BALLI-01 Trial of UCART22, an Anti-CD22 Allogeneic CAR-T Cell Product, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Presenter: Nicolas Boissel, M.D., Ph.D., Hôpital St Louis, Assistance Publique – Hôpitaux de Paris, Paris, France

Abstract and logistic details are available on www.ehaweb.org

On May 11, 2023 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, and the International Conference on Malignant Lymphoma (ICML), underscoring the company’s momentum towards delivering treatment options with the hope to transform clinical outcomes for patients (Press release, Bristol-Myers Squibb, MAY 11, 2023, View Source [SID1234631491]). Data from more than 160 company-sponsored studies, investigator-sponsored studies and collaborations evaluating compounds spanning 20 cancer types and serious blood disorders will be featured across the three meetings, including the COMMANDS study, which has been selected for the official ASCO (Free ASCO Whitepaper) press program (Abstract #7003) and EHA (Free EHA Whitepaper) plenary session (Abstract #S102).

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"We look forward to sharing our research during ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ICML, demonstrating the diversity of our assets, cutting-edge pipeline, and science-driven strategy focused on shaping the next generation of cancer care," said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. "The breadth of data and results illustrate how we are leveraging novel technologies to develop therapies that disrupt the course of disease for patients with solid tumors, blood cancers, and blood disorders. Positive study outcomes are critical, and so is ensuring those results represent and can benefit a diverse population of patients. Our health equity commitments are enabling inclusive innovation, better science and greater reach of our medicines to the patients who need them most."

Key data being presented by Bristol Myers Squibb at ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ICML 2023 include:

Hematology

First disclosure of data from the Phase 3 COMMANDS study of Reblozyl (luspatercept-aamt)versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), demonstrated highly statistically significant and clinically meaningful improvement in patients with anemia associated with very low- to intermediate-risk myelodysplastic syndromes, who require red blood cell (RBC) transfusions and are ESA-naïve. (ASCO/EHA)

Preliminary results from the dose-escalation and expansion components of the Phase 1 CC-93269-MM-001 study demonstrate subcutaneous administration of bispecific T-cell engager alnuctamab exhibited promising dose-dependent anti-tumor activity in heavily pretreated multiple myeloma, with a high proportion of responders achieving minimal residual disease negativity. (EHA) (Free EHA Whitepaper)

Results from the dose-escalation components of a Phase 1/2 study evaluating BET inhibitor BMS-986158 as monotherapy and in combination with ruxolitinib or Inrebic (fedratinib), show generally manageable safety and robust spleen volume reduction in patients with intermediate- or high-risk myelofibrosis. (EHA) (Free EHA Whitepaper)

First disclosure of clinical data from a Phase 1b study evaluating golcadomide (CC-99282), a novel CELMoDTM agent, in combination with R-CHOP in patients with previously untreated aggressive B-cell lymphoma will be presented. (ICML)

Results from a dose-expansion cohort of the Phase 1/2 CC-92480-MM-001 study, evaluating novel CELMoD agent, mezigdomide, with dexamethasone in patients with relapsed/refractory multiple myeloma, showed the combination’s safety profile and promising efficacy in patients with triple-class refractory multiple myeloma. (EHA) (Free EHA Whitepaper)
Cell Therapy

First disclosure of data from the primary analysis of the TRANSCEND CLL 004 study of Breyanzi (lisocabtagene maraleucel) demonstrated deep and durable responses and a manageable safety profile, with no new safety signals, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. (ASCO) (Free ASCO Whitepaper)
Multiple analyses from the KarMMa-3 study showed improved health-related quality of life (HRQOL) and patient-reported outcomes, in addition to lower risk of disease progression, with Abecma (idecabtagene vicleucel), regardless of baseline high-risk disease or number of prior lines of therapy, in patients with triple-class exposed relapsed and refractory multiple myeloma. (ASCO/EHA)
Interim results from Phase 1 study of GPRC5D CAR T (BMS-986393/CC-95266) demonstrated durable responses with an overall generally manageable safety profile, including in patients with prior BCMA-directed therapy. (EHA) (Free EHA Whitepaper)
Solid Tumor

Results from the registrational TRIDENT-1 trial showed durable clinical activity with repotrectinib in ROS1 tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with locally advanced or metastatic ROS1-positive NSCLC with or without baseline central nervous system metastases, including robust intracranial responses. (ASCO) (Free ASCO Whitepaper)
Four-year data from the Phase 3 CheckMate -9LA trial reinforce durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for patients with metastatic NSCLC, including subgroups with higher unmet needs. (ASCO) (Free ASCO Whitepaper)
Three-year results demonstrated long-term clinical benefit of neoadjuvant Opdivo with chemotherapy in patients with resectable NSCLC who received definitive surgery in the Phase 3 CheckMate -816 trial. (ASCO) (Free ASCO Whitepaper)
Biomarker analyses from the Phase 3 CheckMate -76K trial support a potential clinical benefit of Opdivo for the adjuvant treatment of patients with stage IIB/C melanoma, across all biomarker sub-groups. (ASCO) (Free ASCO Whitepaper)
Three-year data from the Phase 3 CheckMate -649 trial evaluating Opdivo plus chemotherapy continue to demonstrate durable long-term survival and HRQOL benefits in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (ASCO) (Free ASCO Whitepaper)
Two-year data from the Phase 2/3 RELATIVITY-047 trial showed consistent benefit with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in patients with previously untreated metastatic or unresectable melanoma. (ASCO) (Free ASCO Whitepaper)
Please see below for Important Safety Information and full Prescribing Information for Reblozyl, Opdualag, Opdivo, and Opdivo+Yervoy.

Please see below for Important Safety Information and full Prescribing Information, including Boxed Warnings, for Abecma, Breyanzi and Inrebic.

Investor Event

Bristol Myers Squibb will host a virtual Investor Event on Tuesday, June 6, 2023, from 7:00-8:00 a.m. CT/8:00-9:00 a.m. ET to discuss data presented at ASCO (Free ASCO Whitepaper). Company executives will provide an overview of data presented and address questions from investors and analysts.

Investors and the general public are invited to listen to a live webcast of the event at View Source An archived edition of the session will be available later that day.

Summary of Presentations

Select Bristol Myers Squibb studies at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Abstract Title

Author

Presentation
Type/#

Session Title

Session
Date/Time
(EDT)

Acute Myeloid Leukemia

Implications for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic: A Connect Myeloid Registry study.

Bart L. Scott

Poster

Abstract #7021

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Gastrointestinal

First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): 64-month (mo) follow-up from CheckMate 142.

Heinz-Josef Lenz

Poster

Abstract #3550

Gastrointestinal Cancer—Colorectal and Anal

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Predictive value of tumor-infiltrating lymphocyte (TIL) dynamics in the tumor microenvironment (TME) during preoperative chemoradiotherapy (CRT) on pathologic complete response (pCR) in microsatellite-stable (MSS) locally advanced rectal cancer (LARC).

Mitsuho Imai

Poster

Abstract #3608

Gastrointestinal Cancer—Colorectal and Anal

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Nivolumab (NIVO) plus chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 3-year follow-up from CheckMate 649.

Yelena Y. Janjigian

Poster

Abstract #4025

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): 36-month results of nivolumab plus chemotherapy (N+C) versus (C) from CheckMate 649.

Elena Elimova

Poster

Abstract #4038

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Genitourinary

Health-related quality of life (HRQoL) of risk-based patient subgroups with advanced renal cell cancer (aRCC) treated with nivolumab plus cabozantinib (NIVO+CABO) vs sunitinib (SUN) in the CheckMate 9ER trial.

David Cella

Poster

Abstract #4527

Genitourinary Cancer—Kidney and Bladder

Saturday,
June 3, 2023

9:00 AM –
12:00 PM

Adjuvant nivolumab plus ipilimumab vs placebo for patients with localized renal cell carcinoma at high risk of relapse after nephrectomy: Subgroup analyses from the phase 3 CheckMate 914 (part A) trial.

Robert J. Motzer

Oral

Abstract #4506

Genitourinary Cancer—Kidney and Bladder

Monday,
June 5, 2023

12:30 PM –
3:30PM

Gynecologic

Preliminary antitumor activity of the combination of COM701 + BMS-986207 + nivolumab in patients with recurrent, metastatic MSS endometrial cancer.

Drew W. Rasco

Poster

Abstract #5595

Gynecologic Cancer

Monday,
June 5, 2023

2:15 PM –
5:15 PM

Efficacy and final safety analysis of pre- and co-administration of nivolumab (Nivo) with concurrent chemoradiation (CCRT) followed by Nivo maintenance therapy in patients (pts) with locally advanced cervical carcinoma (LACvCa): Results from the phase I trial, GOTIC-018.

Kazuto Nakamura

Poster

Abstract #5519

Gynecologic Cancer

Monday,
June 5, 2023

5:30 PM –
7:00 PM

Preclinical testing of farletuzumab ecteribulin (FZEC [MORAb-202]) and MORAb-109, folate receptor α and mesothelin targeting antibody-drug conjugates (ADCs), in rare gynecologic cancers.

Cassandra Vandenberg

Publication Only

Abstract #e17634

Gynecologic Cancer

N/A

Head & Neck

A phase 2, open-label, multicenter study investigating efficacy and safety of RP3 oncolytic immunotherapy combined with other therapies in patients with locoregionally advanced or recurrent squamous cell carcinoma of the head and neck.

Kevin Joseph Harrington

Poster

Abstract #TPS6106

Head and Neck Cancer

Monday,
June 5, 2023

2:15 PM –
5:15 PM

Lymphoma

Longitudinal, prospective cardiovascular and metabolic risk in treatment-naive patients with chronic myeloid leukemia in chronic phase (CML-CP) starting tyrosine kinase inhibitor (TKI) therapy in a real-world setting.

Javid J. Moslehi

Poster

Abstract #7053

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Subgroup analyses of primary refractory (refr) vs early relapsed (rel) large B-cell lymphoma (LBCL) from the TRANSFORM study of lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line (2L) therapy.

Loretta J. Nastoupil

Poster

Abstract #7526

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Response-adapted therapy (tx) with nivolumab plus brentuximab vedotin (nivo + BV) without autologous hematopoietic cell transplantation (auto-HCT) in children, adolescents, and young adults (CAYA) with low-risk relapsed/refractory (R/R) classic Hodgkin lymphoma (cHL): CheckMate 744.

Paul David Harker-Murray

Poster

Abstract #7515

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,
June 5, 2023

2:15 PM –
3:45 PM

Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004.

Tanya Siddiqi

Oral

Abstract #7501

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Tuesday,
June 6, 2023

10:45 AM –
1:45 PM

Melanoma

The validity of a machine learning algorithm in predicting response to immune checkpoint inhibitors in melanoma.

Faisal Fa’ak

Poster

Abstract #9523

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of RP2 as a single agent and in combination with nivolumab in a cohort of patients with uveal melanoma.

Joseph J. Sacco

Poster

Abstract #9527

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Durable clinical outcomes in patients (pts) with advanced melanoma and progression-free survival (PFS) ≥3y on nivolumab (NIVO) ± ipilimumab (IPI) or IPI in CheckMate 067.

F. Hodi

Poster

Abstract #9542

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Efficacy and safety of first-line (1L) nivolumab plus relatlimab (NIVO + RELA) versus NIVO plus ipilimumab (NIVO + IPI) in advanced melanoma: An indirect treatment comparison (ITC) using patient-level data (PLD).

Dirk Schadendorf

Poster

Abstract #9552

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Association of circulating tumor DNA kinetics with disease recurrence in patients with stage IIB/C/IV melanoma treated with adjuvant immunotherapy in CheckMate 238.

Mahrukh M. Syeda

Poster

Abstract #9577

Melanoma/Skin Cancers

Saturday,
June 3, 2023

2:15 PM –
5:15 PM

Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year results from RELATIVITY-047.

Hussein A. Tawbi

Oral

Abstract #9502

Melanoma/Skin Cancers

Monday,
June 5, 2023

4:00 PM –
7:00 PM

Association of biomarkers (BMs) with efficacy of adjuvant nivolumab (NIVO) vs placebo (PBO) in patients with resected stage IIB/C melanoma (CA209 -76K).

Georgina V. Long

Oral

Abstract #9504

Melanoma/Skin Cancers

Monday,
June 5, 2023

4:00 PM –
7:00 PM

Merkel Cell Carcinoma

Non-comparative, open-label, international, multicenter phase I/II study of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic Merkel cell carcinoma (MCC) (CheckMate 358).

Shailender Bhatia

Oral

Abstract #9506

Melanoma/Skin Cancers

Monday,
June 5, 2023

4:00 PM –
7:00 PM

Multiple Myeloma

Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM).

Julia Piasecki

Poster

Abstract #8031

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Health related quality of life (HRQoL) in patients with triple-class-exposed relapsed/refractory multiple myeloma (TCE RRMM) treated with idecabtagene vicleucel (ide-cel) versus standard regimens: Patient-reported outcomes (PROs) from KarMMa-3 phase 3 randomized controlled trial (RCT).

Michel Delforge

Poster

Abstract #8032

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Tumor-intrinsic features associated with progression-free survival (PFS) in patients (pts) with relapsed and refractory multiple myeloma (RRMM) treated with idecabtagene vicleucel (ide-cel).

Nicholas Strong

Poster

Abstract #8035

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

EXCALIBER-RRMM: A phase 3, two-stage study of iberdomide, daratumumab, and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM).

Sagar Lonial

Poster

Abstract #TPS8069

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

A phase 3, two-stage, randomized study of mezigdomide, carfilzomib, and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM): SUCCESSOR-2.

Paul G. Richardson

Poster

Abstract #TPS8070

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Myelodysplastic Syndrome

Efficacy and safety results from the COMMANDS trial: A phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (ESA)-‑naive transfusion-dependent (TD) patients (pts) with lower-‑risk myelodysplastic syndromes (LR-MDS).

Guillermo Garcia-Manero

Oral

Abstract #7003

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Friday,
June 2, 2023

2:00 PM –
5:00 PM

Hematologic and transfusion outcomes in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) receiving luspatercept: Real-world assessment in the community practice setting.

Sudipto Mukherjee

Poster

Abstract #7057

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Clinical outcomes by SF3B1 mutation status in patients (pts) with lower-risk myelodysplastic syndrome (LR-MDS) retreated with erythropoiesis-stimulating agents (ESAs).

Adeola Y. Makinde

Poster

Abstract #7071

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

A phase 2/3 trial of oral azacitidine (Oral-AZA) in patients (pts) with low- or intermediate-risk myelodysplastic syndromes (MDS).

Guillermo Garcia-Manero

Poster

Abstract #TPS7083

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

9:00 AM –
12:00 PM

Myelofibrosis

Safety and efficacy of luspatercept for the treatment of anemia in patients with myelofibrosis: Results from the ACE-536-MF-001 study.

Aaron Thomas Gerds

Poster

Abstract #7016

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,
June 5, 2023

12:30 PM –
2:00 PM

Thoracic

Phase 2 small cell lung cancer (SCLC) cohort of a phase 1b/2 trial of a liposomal formulation of eribulin in combination with nivolumab.

Koichi Azuma

Poster

Abstract #8593

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday,
June 4, 2023

9:00 AM –
12:00 PM

Clinical outcomes with neoadjuvant nivolumab (N) + chemotherapy (C) vs C by definitive surgery in patients (pts) with resectable NSCLC: 3-y results from the phase 3 CheckMate 816 trial.

Jonathan Spicer

Poster

Abstract #8521

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday,
June 4, 2023

12:30 PM –
2:00 PM

Intracranial and systemic efficacy of repotrectinib in advanced ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) and central nervous system metastases (CNS mets) in the phase 1/2 TRIDENT-1.

Jessica Jiyeong Lin

Poster

Abstract #9017

Lung Cancer—Non-Small Cell Metastatic

Sunday,
June 4, 2023

5:30 PM –
7:00 PM

First-line (1L) nivolumab (N) + ipilimumab (I) + chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4‑y clinical update and outcomes by tumor histologic subtype (THS).

David Paul Carbone

Poster

Abstract #LBA9023

Lung Cancer—Non-Small Cell Metastatic

Sunday,
June 4, 2023

5:30 PM –
7:00 PM

All abstracts except late-breaking abstracts will be available on the ASCO (Free ASCO Whitepaper) website at 5:00 PM EDT on Thursday, May 25. All late-breaking abstracts will be available on the ASCO (Free ASCO Whitepaper) website at 8:00 AM EDT on the day of the scientific session for the abstract presentation.

Select Bristol Myers Squibb studies at the 2023 EHA (Free EHA Whitepaper) Congress include:

Abstract Title

Author

Presentation
Type/#

Session
Date/ Time
(EDT)

Acute Myeloid Leukemia

Longitudinal characterization of molecular variants at remission and relapse: subanalyisis of the QUAZAR AML-001 trial.

Andrew Wei

Poster

Abstract #P411

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Disease monitoring of NPM1-mutant (mut) acute myeloid leukemia (AML) using measurable residual disease (MRD) assessments during oral azacitidine (oral-AZA) treatment (tx): a QUAZAR AML-001 subanalysis.

Gail Roboz

Poster

Abstract #P459

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

A real-world evaluation of treatment patterns and outcomes of acute myeloid leukemia induction therapies in the community setting.

Keri Maher

Poster

Abstract #P515

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Phase 1b OMNIVERSE trial: Safety and tolerability of oral azacitidine in combination with venetoclax for treatment of acute myeloid leukemia.

Shaun Fleming

Poster

Abstract #P567

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Real-world characteristics and use of antiemetic therapies among patients with acute myeloid leukemia treated with oral azacitidine maintenance therapy.

Ying Qui

Poster

Abstract #P587

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Implications of registry data for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic.

John Kelly

Poster

Abstract #P589

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Beta Thalassemia

Effect of luspatercept on bone mineral density in patients with beta-thalassemia enrolled in the phase 3 BELIEVE trial.

Thomas D. Coates

Poster

Abstract #P1466

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Long-term erythroid response data from patients (pts) with non-transfusion-dependent beta-thalassemia (NTDT) receiving luspatercept in the BEYOND trial.

Ali T. Taher

Oral

Abstract #S273

Sunday, June 11, 2023

5:30 – 6:45 AM (11:30 AM

– 12:45 PM CEST)

Alpha Thalassemia

Trial in Progress: A phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of luspatercept to treat anemia in adults with alpha-thalassemia.

Vip Viprakasit

Abstract only publication

Abstract #PB2535

N/A

Lymphoma

Economic burden in chronic lymphocytic leukemia (CLL) for patients with ≥2 prior lines of therapy including a bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i).

Farrukh Awan

Poster

Abstract #P1696

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Qualitative interviews to describe burden in patients (pt) with third-line or later CLL/SLL with prior exposure to bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i).

Mona L Martin

Abstract only publication

Abstract #PB2696

N/A

Multiple Myeloma

Synergistic antitumor activity of the BCMA 2+1 T cell engager (TCE) alnuctamab (ALNUC; BMS-986349; CC-93269) and CELMoD agents in multiple myeloma (MM) preclinical models.

Bruno Paiva

Poster

Abstract #P799

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class-exposed relapsed and refractory multiple myeloma.

Marc S. Raab

Poster

Abstract #P801

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Baseline characteristics identifying patients with multiple myeloma treated with idecabtagene vicleucel (ide-cel; BB2121) who are at risk for severe/refractory inflammatory adverse events.

Yi Lin

Poster

Abstract #P809

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Soluble factors correlated with cytokine release syndrome (CRS) with IV vs subcutaneous (SC) alnuctamab (ALNUC; BMS-986349; CC-93269) in patients with relapsed/refractory multiple myeloma (RRMM).

Luciano Costa

Poster

Abstract #P825

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class-exposed (TCE) relapsed and refractory multiple myeloma (RRMM): KarMMa-3 subgroup analysis by prior lines of therapy.
Saloman Manier

Poster

Abstract #P866

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Mezigdomide (MEZI) plus dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): results from the dose-expansion phase of the CC-92480-MM-001 trial.

Nizar J. Bahlis

Poster

Abstract #P868

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Idecabtagene vicleucel (ide-cel) in patients with an inadequate response to frontline autologous stem cell transplantation (ASCT): results from KarMMa-2 cohort 2c.

Melissa Alsina

Poster

Abstract #P871

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Pomalidomide, daratumumab, and dexamethasone after lenalidomide treatment in patients with relapsed or refractory multiple myeloma (RRMM): final overall survival analysis of the phase 2 MM-014 study.

Nizar J. Bahlis

Poster

Abstract #P882

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Alnuctamab (ALNUC; BMS-986349; CC-93269), a BCMA × CD3 T-cell engager, in patients (pts) with relapsed/refractory multiple myeloma (RRMM): latest results from a phase 1 first-in-human clinical study.

Sandy W. Wong

Poster

Abstract #P883

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Patient reported outcomes in triple class exposed, relapsed/refractory multiple myeloma (TCE RRMM) patients in KarMMa-3 trial (phase 3 RCT): idecabtagene vicleucel (ide-cel) versus standard regimens.

Michel Delforge

Poster

Abstract #P905

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Treatment patterns and clinical outcomes of patients with multiple myeloma previously treated with lenalidomide and an anti-CD38 monoclonal antibody: findings from the Connect MM disease registry.

Rafat Abonour

Poster

Abstract #P915

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Real-world clinical outcomes among triple-class exposed relapsed refractory multiple myeloma patients in US and Europe: PREAMBLE registry study.

Hartmut Goldschmidt

Poster

Abstract #P945

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

BMS-986393 (CC-95266), a G protein–coupled receptor class C group five member D (GPRC5D)–targeted CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM): Results from a phase 1 study.

Susan Bal

Oral

Abstract #S193

Saturday, June 10, 2023

5:30

– 6:45 AM (11:30 AM

– 12:45 PM CEST)

Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class–exposed (tce) relapsed and refractory multiple myeloma (rrmm): a KarMMa-3 analysis in high-risk subgroups.

Krina Patel

Oral

Abstract #S195

Saturday, June 10, 2023

10:30

– 11:45 AM (4:30

– 5:45 PM CEST)

Elotuzumab or daratumumab in combination with pomalidomide and dexamethasone (EPd and DPd) in relapsed refractory multiple myeloma (RRMM): a network meta-analysis.

Adriana Cury

Abstract only publication

Abstract #PB2095

N/A

Myelodysplastic Syndromes

Luspatercept versus epoetin alfa for treatment (TX) of anemia in ESA-naïve patients with lower-risk myelodysplastic syndromes(LR-MDS) patients (PTS) requiring RBC transfusions: data from the COMMANDS study.

Matteo Giovanni Della Porta

Oral plenary and special session

Abstract #S102

Saturday, June 10, 2023

8:45

– 10:15 AM (2:45

– 4:15 PM CEST)

Luspatercept restores effective erythropoiesis and provides superior and sustained benefit vs epoetin alfa: biomarker analysis from the phase 3 COMMANDS study.

Uwe Platzbecker

Poster

Abstract #P693

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Distinct splicing alternations associated with clinical response to luspatercept in patients with lower-risk myelodysplastic syndromes from the MEDALIST study.

Amit Verma

Poster

Abstract #P697

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Treatment patterns and outcomes among patients with lower-risk myelodysplastic syndromes receiving luspatercept in routine clinical practice in the United States.

Sudipto Mukherjee

Poster

Abstract #P733

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

First-line treatment patterns and outcomes among patients with the newly diagnosed myelodysplastic syndromes: a global, retrospective observational cohort study.

Amer M. Zeidan

Abstract only publication

Abstract #PB2010

N/A

Myelofibrosis

Efficacy and safety of luspatercept for the treatment of anemia in patients with myelofibrosis: results from the ACE-536-MF-001 Study.

Francesco Passamonti

Oral

Abstract #S167

Friday, June 9, 2023

8:45

– 10:00 AM (2:45

– 4:00 PM CEST)

Fedratinib is effective in ruxolitinib-resistant cells: clinical and preclinical correlations.

Vikas Gupta

Poster

Abstract #P997

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

Real-world treatment patterns and healthcare resource utilization in myelofibrosis patients with anemia.

John Mascarenhas

Poster

Abstract #P1059

Friday, June 9, 2023

12:00

– 1:00 PM (6:00

– 7:00 PM CEST)

BMS-986158, a potent BET inhibitor, as monotherapy and in combination with ruxolitinib or fedratinib in intermediate- or high-risk myelofibrosis (MF): results from a phase 1/2 study.

Haifa Kathrin Al-Ali

Oral

Abstract #S213

Saturday, June 10, 2023

5:30 – 6:45 AM (11:30 AM – 12:45 PM CEST)
All EHA (Free EHA Whitepaper) abstracts except late-breaking abstracts will be available on May 11. All late-breaking abstracts will be available on June 1.

Select Bristol Myers Squibb studies at the 2023 ICML Annual Meeting include:

Abstract Title

Author

Presentation
Type/#

Session Title

Session
Date/ Time
(EDT)

Non-Hodgkin Lymphoma

CC-99282 plus R-CHOP in patients (pts) with previously untreated aggressive B-cell lymphoma (aBCL): early safety and efficacy results from a phase 1b study.

Javier Munoz

Poster

Abstract #438

Phase I-II

Wednesday, June 14, 2023

6:00AM

– 12:00 PM (12:00

– 6:00 PM CEST)

Thursday, June 15 – Friday, June 16, 2023

4:00 AM

– 12:00 PM

(10:00 AM

– 6:00 PM CEST)

Open-label phase 1/2 study of CC-99282, a cereblon E3 ligase modulator (CELMoD) agent ± rituximab,

in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).

Jean-Marie Michot

Oral

Abstract #90

Session 14 Novel Agents

Saturday, June 17, 2023

2:45

– 4:15 AM (9:45

– 10:15 AM CEST)

Chronic Lymphocytic Leukemia

Health-related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with liso-cel in TRANSCEND CLL 004.

S.S. Kenderian

Poster

Abstract #400

CAR-T (Cellular Therapies)

Wednesday, June 14, 2023

6:00AM

– 12:00 PM (12:00

– 6:00 PM CEST)

Thursday, June 15

– Friday, June 16, 2023

4:00 AM – 12:00 PM

(10:00 AM ‒ 6:00 PM CEST)

Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): primary analysis of TRANSCEND CLL 004.

Tanya Siddiqi

Oral

Abstract #26

Session 4 CLL and Richter Syndrome

Thursday, June 15, 2023

7:45

– 9:15 AM (1:45

– 3:15 PM CEST)

Large B Cell Lymphoma

Comparison of overall survival of lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) adjusting for crossover in second-line (2L) R/R large B-cell lymphoma.

Franck Morschhauser

Poster

Abstract #332

DLBCL

Wednesday, June 14, 2023

6:00AM

– 12:00 PM (12:00

– 6:00 PM CEST)

Thursday, June 15

– Friday, June 16, 2023

4:00 AM

– 12:00 PM

(10:00 AM

– 6:00 PM CEST)

Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line therapy in large B-cell lymphoma (TRANSFORM study): Subgroup analyses by prior therapy response.

Loretta J. Nastoupil

Oral

Abstract #138

Session 8

"Focus on…"

Large B-Cell and Double Hit Lymphomas

Thursday, June 15

11:00 AM – 12:00 PM (5:00 ‒ 6:00 PM CEST)

All ICML accepted abstracts (except encore abstracts) will be available on June 9.