On May 23, 2024 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) reported that senior management will present at the upcoming TD Cowen 5th Annual Oncology Innovation Virtual Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) on Wednesday, May 29, 2024 at 12:00 p.m. Eastern Daylight Time / 9:00 a.m. Pacific Daylight Time (Press release, Coherus Biosciences, MAY 23, 2024, View Source [SID1234643585]). The presentation will be accessible via Webcast through a link on the Investor Events and Presentations section of the Coherus website: View Source This webcast will be available for replay until June 26, 2024.

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On May 23, 2024 CatalYm reported that positive new follow-up results from its ongoing "GDFATHER" Phase 1/2a trial (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 1/2a) will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 in Chicago (Press release, Catalym, MAY 23, 2024, View Source [SID1234643584]).

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The trial is evaluating CatalYm’s lead GDF-15 neutralizing antibody, visugromab, in combination with immune checkpoint inhibitor nivolumab in late- to last-line, anti-PD-1/PD-L1 relapsed/refractory patients. Visugromab is designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), a central mediator of immune resistance to cancer therapies. Early interim data of the study, which were previously presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2023, demonstrated signs for potent and durable anti-tumor efficacy as well as an excellent tolerability and safety profile for visugromab in combination with nivolumab in advanced-stage/last-line non-small cell lung cancer (NSCLC) and urothelial cancer patients (UC). Now matured data for NSCLC, UC and novel data for hepatocellular cancer (HCC) will be presented.

The ASCO (Free ASCO Whitepaper) Annual Meeting will be held in Chicago, Illinois, from May 31 to June 4, 2024.

Oral Presentation Details:
Presentation Title: Effects of neutralization of tumor-derived immunosuppressant GDF-15 on anti-PD-1 activity in anti-PD-(L)1 relapsed/refractory non-squamous NSCLC, urothelial, and hepatocellular cancer
Presenter: Dr. Ignacio Melero Bermejo, MD | Clinica Universidad de Navarra
Session: Developmental Therapeutics-Immunotherapy
Session Date and Time: Sunday, June 2, 2024, from 11:30 AM – 1:00 PM CDT
Location: S406 | On Demand | McCormick Place
Abstract Number: 2513

The full abstract details can be accessed via View Source The company will provide further information and a summary of the data following the oral presentation at ASCO (Free ASCO Whitepaper).

On May 23, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported topline overall survival data from its phase 2 clinical trial of CAN-2409, a multimodal biological immunotherapy candidate, plus valacyclovir (prodrug), together with standard of care (SoC) immune checkpoint inhibitor (ICI) therapy in patients with Stage III/IV non-small cell lung cancer (NSCLC) inadequately responding to ICI (anti-PD-(L)1) therapy (Press release, Candel Therapeutics, MAY 23, 2024, View Source [SID1234643583]). The data will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago, May 31 to June 4, 2024, by Charu Aggarwal, MD, MPH, FASCO, Leslye M. Heisler Associate Professor for Lung Cancer Excellence at the Perelman School of Medicine, University of Pennsylvania and Co-Principal Investigator of the clinical trial.

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Highlights of the presentation include: 1) median overall survival (mOS) of 20.6 months achieved in patients with progressive disease despite ICI treatment after two administrations of CAN-2409 plus prodrug; for context, in a 2022 publication of a clinical trial in a similar patient population, mOS in the control arm that received SoC docetaxel-based chemotherapy was 11.6 months; improved survival was observed across both PD-(L)1 positive and PD-(L)1 negative tumors; 2) beneficial effect on both

injected and uninjected tumors in more than 70% of the patients with metastatic disease and at least one uninjected tumor; and 3) a significant increase in circulating CD8+ cytotoxic and CD4+ effector and central memory T cells and increased soluble granzyme B levels in peripheral blood after the second (‘booster’) injection of CAN-2409, associated with subsequent prolonged survival (in each case, as of an April 1 data cut-off). Together, these data continue to support the emerging differentiated profile of CAN-2409 in this difficult-to-treat condition.

"The results from our phase 2 trial in NSCLC continue to support the tremendous promise of CAN-2409 across multiple solid tumors. We are particularly encouraged by the overall survival observed in the patients whose disease had progressed despite receiving prior anti-PD-(L)1 treatment. Improved overall survival is, ultimately, what matters to patients and to the regulators," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "These results, together with our recently reported overall survival data in a randomized clinical trial in pancreatic cancer, add to the growing body of evidence supporting the notion that CAN-2409 treatment may convert progressive cancer into stable disease associated with survival benefit in advanced cancers with high unmet medical needs."

Previously, the Company received FDA Fast Track Designation for CAN-2409 in NSCLC and pancreatic cancer as well as orphan drug designation in pancreatic cancer.

"Current therapeutic options for advanced NSCLC patients whose disease progresses despite ICI treatment are limited; they are characterized by poor tolerability and limited clinical benefit," said Charu Aggarwal, MD, MPH, FASCO. "The data reported today suggest that CAN-2409 can reactivate these patients’ exhausted immune systems, including those with low PD-(L)1 expression. This systemic anti-tumor immune response translated to a durable response; increased numbers of circulating cytotoxic and memory T cells were associated with subsequent prolonged survival. I look forward to the continued development of CAN-2409 in NSCLC as a promising approach in an area of unmet therapeutic need."

ASCO presentation highlights:

•
The open label phase 2 clinical trial evaluated the efficacy and safety of the combination of CAN-2409 plus prodrug (valacyclovir) and continued, unaltered ICI therapy in patients with an inadequate response to ICI after at least 18 weeks of treatment. The objective of the analysis presented at ASCO (Free ASCO Whitepaper) was to explore whether experimental treatment with CAN-2409 plus prodrug could improve mOS in patients treated with two injections.
•
46 patients received two administrations of CAN-2409 plus prodrug and were evaluable per protocol.

Cohort 1

Stable Disease at Study Entry

n=5

Cohort 2

Progressive Disease at Study Entry

n=41

•
Demographic characteristics of the safety population:
img160460863_1.jpg

•
We confirmed previously released data on the ability of CAN-2409 to control disease, with a disease control rate of 100% in cohort 1 and 70% in cohort 2 patients.
•
As of April 1, 2024, mOS of 22.0 months was observed across all 46 patients who had an inadequate response to ICI (both cohorts 1 and 2).
In patients with progressive disease despite ICI treatment (cohort 2), a mOS of 20.6 months was observed. A 2022 publication of a clinical trial in a similar patient population reported mOS of 11.6 months for SoC docetaxel-based chemotherapy.1

•
Improved mOS was observed in both PD-(L)1 negative and PD-(L)1 positive tumors in patients with progressive disease (n=37 patients in cohort 2 for which PD-(L)1 status at baseline was available).
PD-(L)1 Subgroup

Number of Patients

mOS (months)

Negative (<1%)

16

24.5 (7.0, NA)

Positive (>=1%)

21

20.6 (5.5, NA)

•
71.4% of patients with metastatic disease and at least one uninjected tumor (n=35) experienced a beneficial effect on both injected and uninjected tumors, indicating a systemic anti-tumor immune response. When using a threshold of >5% decrease, more than 60.0% of patients showed an abscopal response.

•
Increased numbers of circulating CD8+ cytotoxic and CD4+ effector and central memory T cells as well as elevated levels of soluble granzymes B and H after the second CAN-2409 injection were associated with subsequent prolonged survival, underpinning the systemic immune response elicited by CAN-2409 treatment.

•
Treatment with CAN-2409 in NSCLC continued to exhibit a favorable safety and tolerability profile. Bronchoscopic delivery of CAN-2409 is an extension of
existing care for patients with NSCLC. As of April 1, 2024, there were no dose-limiting toxicities or grade 4 or higher treatment-related adverse events (TRAEs); the majority of TRAEs were grade 1 or 2, and there were three grade 3 TRAEs (one pyrexia, two pneumonitis).

Details on the CAN-2409 ASCO (Free ASCO Whitepaper) abstract are as follows:

•
Poster Presentation Title: Overall survival after treatment with CAN-2409 plus valacyclovir in combination with continued ICI in patients with stage III/IV NSCLC with inadequate response to ICI

•
Presenter: Charu Aggarwal, MD, MPH, FASCO, Leslye M. Heisler Associate Professor for Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania

•
Session Title: Poster Session – Lung Cancer – Non-Small Cell Metastatic

•
Session Date/Time: Monday, June 3, 2024; 1:30 PM – 4:30 PM CT

•
Location: Hall A, McCormick Place Convention Center, Chicago, IL

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events.

Currently, Candel is evaluating CAN-2409 in NSCLC, borderline resectable PDAC, and localized, non-metastatic prostate cancer in ongoing clinical trials. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer is being conducted under a Special Protocol Assessment with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC.

On May 23, 2024 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data across its oncology and hematology portfolio at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress (Press release, Bristol-Myers Squibb, MAY 23, 2024, View Source;EHA-from-More-Than-130-Studies-Across-25-Diseases-Supporting-Expansion-into-New-Indications-Demonstrating-Long-Term-Survival-and-Highlighting-Novel-Modalities-and-Research-Platforms/default.aspx [SID1234643582]). Data from more than 130 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning approximately 25 cancer types and serious blood disorders.

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"At this year’s ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings, we have the opportunity to share data across our robust and differentiated oncology portfolio including new data from pivotal studies, data that reinforce the longer-term impact our medicines are having for patients, and emerging science in the oncology space," said Samit Hirawat, M.D., executive vice president, chief medical officer, Drug Development, Bristol Myers Squibb. "We are focused on advancing critical research across immuno-oncology, targeted therapy, protein degradation, cell therapy, and radiopharmaceutical therapy, all with the goal of delivering potentially transformative treatment options that help provide long-term benefit for patients."

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

New pivotal data

Progression-free survival and overall response rate data from the Phase 3 KRYSTAL-12 study evaluating KRAZATI (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. (ASCO) (Free ASCO Whitepaper)
First disclosure of results from the Phase 3 CheckMate -9DW trial demonstrating overall survival benefit with Opdivo (nivolumab) plus Yervoy (ipilimumab) vs. investigator’s choice of lenvatinib or sorafenib as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC). (ASCO) (Free ASCO Whitepaper)
Data strengthening the profile of our existing portfolio

Three-year follow-up data from the Phase 3 RELATIVITY-047 study demonstrating sustained responses with Opdualag (nivolumab and relatlimab-rmbw) in previously untreated metastatic or unresectable melanoma. (ASCO) (Free ASCO Whitepaper)
Five-year data from the Phase 3 CheckMate -9LA trial showing favorable clinical outcomes and durable survival benefit in patients with metastatic NSCLC treated with Opdivo plus Yervoy with chemotherapy vs. chemotherapy. (ASCO) (Free ASCO Whitepaper)
Four-year follow-up data from the Phase 3 CheckMate -816 trial reinforcing neoadjuvant Opdivo plus chemotherapy as a treatment in resectable NSCLC. (ASCO) (Free ASCO Whitepaper)
Exploratory analysis from the Phase 3 CheckMate -77T trial supporting the potential use of a perioperative Opdivo-based regimen as a treatment option for patients with resectable NSCLC, regardless of nodal status. (ASCO) (Free ASCO Whitepaper)
Multiple subgroup analyses from the Phase 1/2 TRANSCEND CLL 004, Phase 1 TRANSCEND NHL 001 (MCL cohort) and Phase 2 TRANSCEND FL studies reinforcing the deep and durable responses with Breyanzi (lisocabtagene maraleucel), demonstrating consistent clinical outcomes in relapsed/refractory chronic lymphocytic leukemia (CLL), relapsed/refractory mantle cell lymphoma (MCL) and relapsed/refractory follicular lymphoma (FL) across a broad study population. (ASCO/EHA)
Emerging science

Efficacy and safety data from the Phase 2/3 RELATIVITY-048 trial evaluating the triplet combination of nivolumab, relatlimab, and ipilimumab in patients with advanced melanoma. (ASCO) (Free ASCO Whitepaper)
Safety and efficacy data from the Phase 1b portion of the ACTION-1 trial of RYZ101 (an alpha-emitting radiopharmaceutical in development for SSTR2+ solid tumors) in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy. (ASCO) (Free ASCO Whitepaper)
First results from the Phase 1 study of GPRC5D-directed CAR T cell therapy (BMS-986393/CC-95266) showcasing promising preliminary efficacy and safety outcomes with a single infusion of BMS-986393 in patients with relapsed or refractory multiple myeloma, including in patients with prior BCMA-directed therapy, who have received one to three prior regimens. (EHA) (Free EHA Whitepaper)
New Phase 1/2 data from the targeted protein degradation platform including the novel oral CELMoD agents iberdomide in newly diagnosed multiple myeloma, mezigdomide in relapsed/refractory multiple myeloma, and golcadomide in first-line LBCL and relapsed/refractory FL, reinforcing promising activity. (ASCO/EHA)
Please see below for Important Safety Information and full Prescribing Information for Opdualag, Opdivo, Opdivo + Yervoy, Augtyro (repotrectinib), Reblozyl (luspatercept-aamt) and KRAZATI.

Please see below for Important Safety Information and full Prescribing Information, including Boxed Warnings, for Abecma (idecabtagene vicleucel), Breyanzi and Inrebic (fedratinib).

Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.

Summary of Presentations:

Select Bristol Myers Squibb studies at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting include:

(all times in Central Time)

Abstract Title

Author

Presentation

Type/#

Session Title

Session

Date/Time

(CDT)

Acute Myeloid Leukemia (AML)

A post-hoc analysis of outcomes of patients with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received oral azacitidine (Oral-AZA) maintenance therapy in the QUAZAR AML-001 study.

Stéphane De Botton

Poster

Abstract #6522

Hematologic Malignancies— Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Bladder Cancer

SOGUG-Vexillum: Phase II non-randomized clinical trial of nivolumab/ipilimumab maintenance following first-line chemotherapy in unresectable locally advanced or metastatic urothelial cancer.

Guillermo De Velasco

Poster

Abstract #4576

Genitourinary Cancer—Kidney and Bladder

Sunday,

June 2, 2024

9:00 AM – 12:00 PM

Characterization of complete responders to nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin alone and patients with lymph node-only metastatic urothelial carcinoma from the CheckMate 901 trial.

Matthew D. Galsky

Oral

Abstract #4509

Genitourinary Cancer—Kidney and Bladder

Monday,

June 3, 2024

8:00 AM – 11:00 AM

Breast Cancer

Phase 2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 (trastuzumab imbotolimod) +/- pertuzumab (P) in patients (pts) with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (T-DXd).

Mark Pegram

Poster

Abstract #TPS1121

Breast Cancer—Metastatic

Sunday,

June 2, 2024

9:00 AM – 12:00 PM

Chronic Lymphocytic Leukemia (CLL)

Evaluating CR as a surrogate endpoint for PFS in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): A meta-analysis of randomized controlled trials (RCT).

Lin Wang

Poster

Abstract #7046

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Association between treatment (tx) response and PFS and OS in R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL): A 12-month landmark (LM) meta-analysis.

Xin Wang

Poster

Abstract #7047

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Colorectal Cancer (CRC)

A phase 2 study evaluating response and biomarkers in patients with microsatellite stable (MSS) advanced colorectal cancer (CRC) treated with nivolumab/relatlimab.

Eric Christenson

Poster

Abstract #3554

Gastrointestinal Cancer—Colorectal and Anal

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Expanded efficacy analysis from CheckMate 8HW.

Heinz-Joseph Lenz

Oral

Abstract #3503

Gastrointestinal Cancer—Colorectal and Anal

Sunday,

June 2, 2024

8:00 AM – 11:00 AM

Esophageal Cancer (EC) and Gastrointestinal Cancers

Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) vs chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): 45-month (mo) follow-up from CheckMate 648.

Ian Chau

Poster

Abstract #4034

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649.

Elena Elimova

Poster

Abstract #4040

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

Updated quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of nivolumab plus chemotherapy versus chemotherapy alone as first-line (1L) treatment for advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma (GC/GEJC/EAC): 4-year (yr) follow-up from CheckMate 649 (CM 649).

Daniel Lin

Poster

Abstract #4044

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

A phase II/III study of peri-operative nivolumab (nivo) and ipilimumab (ipi) in patients (pts) with locoregional esophageal (E) and gastroesophageal junction (GEJ) adenocarcinoma: Results of the neoadjuvant pathologic complete response (pCR) rate (ECOG-ACRIN EA2174).

Jennifer Rachel Eads

Oral

Abstract #4000

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Tuesday,

June 4, 2024

9:45 AM – 12:45 PM

Hepatocellular Carcinoma (HCC)

Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW.

Peter Robert Galle

Oral

Abstract #LBA4008

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Tuesday,

June 4, 2024

9:45 AM – 12:45 PM

Melanoma

Efficacy and safety of triplet nivolumab, relatlimab, and ipilimumab (NIVO + RELA + IPI) in advanced melanoma: Results from RELATIVITY-048.

Paolo Antonio Ascierto

Oral

Abstract #9504

Melanoma/Skin Cancers

Friday,

May 31, 2024

2:45 PM – 5:45 PM

Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma (RELATIVITY-047): Overall survival (OS) and melanoma-specific survival (MSS) outcomes at 3 years.

Hussein A. Tawbi

Poster

Abstract #9524

Melanoma/Skin Cancers

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

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

Dirk Schadendorf

Poster

Abstract #9557

Melanoma/Skin Cancers

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

First-line treatment preferences for advanced melanoma among oncologists and patients in the US: A discrete choice experiment.

Michael A. Postow

Poster

Abstract #9539

Melanoma/Skin Cancers

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

A phase 2, open-label, 2-cohort study to evaluate patient preference for nivolumab (NIVO) + relatlimab (RELA) fixed-dose combination (FDC) subcutaneous (SC) vs NIVO + RELA FDC intravenous (IV) and NIVO SC vs NIVO IV in participants with melanoma.

Steven Y. Liu

Poster

Abstract #TPS9619

Melanoma/Skin Cancers

Saturday,

June 1, 2024

1:30 PM – 4:30 PM

Multiple Myeloma (MM)

Association of patient (pt) factors and pharmacodynamic biomarkers with progression-free survival (PFS) after idecabtagene vicleucel (ide-cel) in pts from KarMMa-3.

Bertrand Arnulf

Poster

Abstract #7527

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Impact of renal impairment (RI) on pharmacokinetics (PK) and clinical outcomes with mezigdomide plus dexamethasone (DEX) in relapsed/refractory multiple myeloma (RRMM).

Suzanne Trudel

Poster

Abstract #7539

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Validation of prototype biomarkers to identify risk factors of inflammatory adverse events (iAEs) following idecabtagene vicleucel (ide-cel) infusion in patients with relapsed and refractory multiple myeloma (RRMM) in KarMMa-3.

Clara Amorosi

Poster

Abstract #7529

Hematologic Malignancies—Plasma Cell Dyscrasia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Myelodysplastic Syndromes (MDS)

Preliminary safety and efficacy of oral azacitidine (Oral-AZA) in patients (pts) with low-/Intermediate (Int)-risk myelodysplastic syndromes (MDS): Phase 2 results from the ASTREON trial.

Guillermo Garcia-Manero

Rapid Oral

Abstract #6509

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Saturday,

June 1, 2024

8:00 AM – 9:30 AM

Clinical benefit of luspatercept treatment (tx) in transfusion-dependent (TD), erythropoiesis-stimulating agent (ESA)-naive patients (pts) with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) in the COMMANDS trial.

Amer Methqal Zeidan

Poster

Abstract #6565

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Non-Hodgkin Lymphoma (includes DLBCL, LBCL, FL, MCL, etc.)

Lisocabtagene maraleucel (liso-cel) in patients (pt) with R/R mantle cell lymphoma (MCL): Subgroup analyses by number of prior systemic lines of therapy (LOT) and by response to prior Bruton tyrosine kinase inhibitor (BTKi) from the TRANSCEND NHL 001 MCL cohort (TRANSCEND-MCL).

M. Lia Palomba

Rapid Oral

Abstract

#7016

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sunday,

June 2, 2024

4:30 PM – 6:00 PM

Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) with salvage chemotherapy (CT) followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients (pt) with R/R large B-cell lymphoma (LBCL): 3-year follow-up (FU) from the randomized, phase 3 TRANSFORM study.

Manali Kirtikumar Kamdar

Rapid Oral

Abstract #7013

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sunday,

June 2, 2024

4:30 PM – 6:00 PM

Real-world outcomes of lisocabtagene maraleucel (liso-cel) in patients (pt) with Richter transformation (RT) from the Center for International Blood and Marrow Transplant Research (CIBMTR).

Allison Marie Winter

Rapid Oral

Abstract #7010

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sunday,

June 2, 2024

4:30 PM – 6:00 PM

Impact of clinical response and AEs on health-related quality of life (HRQoL) in patients (pts) with R/R large B-cell lymphoma (LBCL): Pooled data from 4 lisocabtagene maraleucel (liso-cel) trials.

Patrick Connor Johnson

Poster

Abstract #11105

Quality Care/Health Services Research

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Estimating the health care costs associated with receipt of lisocabtagene maraleucel: Insights from adults with mantle cell lymphoma (TRANSCEND NHL 001).

Tycel Jovelle Phillips

Poster

Abstract #7028

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Impact of bridging therapy (BT) on lisocabtagene maraleucel (liso-cel) treatment in patients (pt) with R/R follicular lymphoma (FL).

M. Lia Palomba

Poster

Abstract #7068

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Patients (pts) with R/R large B-cell lymphoma (LBCL) treated with lisocabtagene maraleucel (liso-cel) nonconforming product (NCP) under the Expanded Access Protocol (EAP).

Mecide Meric Gharibo

Poster

Abstract #7026

Hematologic Malignancies—

Lymphoma and Chronic Lymphocytic Leukemia

Monday,

June 3, 2024

9:00 AM – 12:00 PM

Non-Small Cell Lung Cancer (NSCLC)

KRYSTAL-12: Phase 3 Study of Adagrasib versus Docetaxel in Patients with Previously Treated Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring a KRASG12C Mutation.

Tony Mok

Oral

Abstract #LBA8509

Clinical Science Symposium—Targeting KRAS in Non-Small Cell Lung Cancer

Saturday,

June 1, 2024

1:15 PM – 2:45 PM

Neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) vs chemo in patients (pts) with resectable NSCLC: 4-year update from CheckMate 816.

Jonathan Spicer

Rapid Oral

Abstract #LBA8010

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

Sunday,

June 2, 2024

4:30 PM – 6:00 PM

Clinical outcomes with perioperative nivolumab (NIVO) by nodal status among patients (pts) with stage III resectable NSCLC: Results from the phase 3 CheckMate 77T study.

Tina Cascone

Oral

Abstract #LBA8007

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

Monday,

June 3, 2024

8:00 AM – 11:00 AM

Correlation of the combination of CT-derived tumor texture and vessel tortuosity on survival outcomes for immunotherapy but not for chemotherapy in metastatic non-small cell lung cancer (mNSCLC): Results from a CheckMate227 (CM227) subset.

Pushkar Mutha

Poster

Abstract #8610

Lung cancer—Non-Small Cell Metastatic

Monday,

June 3, 2024

1:30 PM – 4:30 PM

Five-year outcomes with first-line (1L) nivolumab + ipilimumab + chemotherapy (N + I + C) vs C in patients (pts) with metastatic NSCLC (mNSCLC) in CheckMate 9LA.

Martin Reck

Poster

Abstract #8560

Lung cancer—Non-Small Cell Metastatic

Monday,

June 3, 2024

1:30 PM – 4:30 PM

Repotrectinib in tyrosine kinase inhibitor (TKI)-naïve patients (pts) with advanced ROS1 fusion-positive (ROS1+) NSCLC in the phase 1/2 TRIDENT-1 trial: Clinical update, treatment beyond progression and subsequent therapies.

Alexander Drilon

Poster

Abstract #8522

Lung cancer—Non-Small Cell Metastatic

Monday,

June 3, 2024

1:30 PM – 4:30 PM

Pancreatic Cancer

Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings.

Daniel Halperin

Poster

Abstract #3091

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Saturday,

June 1, 2024

9:00 AM – 12:00 PM

Renal Cell Carcinoma (RCC)

Health-related quality of life (HRQoL) with nivolumab (NIVO) subcutaneous (SC) or intravenous (IV) in patients (pts) with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior therapy in the phase 3 CheckMate 67T trial.

Saby George

Poster

Abstract #4535

Genitourinary Cancer—Kidney and Bladder

Sunday,

June 2, 2024

9:00 AM – 12:00 PM

Subcutaneous (SC) nivolumab (NIVO) vs intravenous (IV) NIVO in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Safety and patient-reported outcomes (PROs) of the randomized phase 3 CheckMate 67T trial.

Maria T. Bourlon

Poster

Abstract #4532

Genitourinary Cancer—Kidney and Bladder

Sunday,

June 2, 2024

9:00 AM – 12:00 PM

Intratumoral T-cell infiltration and response to nivolumab plus ipilimumab in patients with metastatic clear cell renal cell carcinoma from the CheckMate-214 trial.

Sayed Matar

Poster

Abstract #4536

Genitourinary Cancer— Kidney and Bladder

Sunday,

June 2, 2024

9:00 AM – 12:00 PM

Partitioned overall survival: Comprehensive analysis of survival states over 4 years in CheckMate 9ER comparing first-line nivolumab plus cabozantinib versus sunitinib in advanced renal cell carcinoma (aRCC).

Charlene Mantia

Oral

Abstract #4507

Genitourinary Cancer—Kidney and Bladder

Monday,

June 3, 2024

8:00 AM – 11:00 AM

Brain Cancer

Phase II study of enasidenib in IDH2-mutated malignant sinonasal and skull base tumors.

Elisabetta Xue

Poster

#TPS3183

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Saturday,

June 1, 2024

9:00 AM – 12:00 PM

All abstracts, except late-breaking abstracts, are available on the ASCO (Free ASCO Whitepaper) website as of 5:00 PM EDT on Thursday, May 23. 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 2024 EHA (Free EHA Whitepaper) Congress include:

(all times in Eastern Daylight and Central European Time)

Abstract Title

Author

Presentation

Type

Session Date/Time

(EDT/CET)

Acute Myeloid Leukemia (AML )

A post hoc analysis of outcomes of patients with acute myeloid leukemia with myelodysplasia-related changes who received oral azacitidine maintenance therapy in the QUAZAR AML-001 study.

Maria Teresa Voso

Oral

Abstract #S141

Saturday, June 15, 2024

11:30 AM – 12:45 PM (16:30 – 17:45 CET)

Impact of TP53 mutations in patients with acute myeloid leukemia (AML) during oral azacitidine maintenance therapy: Outcomes from the QUAZAR AML-001 trial.

Andrew H. Wei

Poster

Abstract #P560

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Chronic Lymphocytic Leukemia (CLL )

Characteristics associated with response to lisocabtagene maraleucel (liso-cel) in patients (PTS) with R/R CLL/SLL: Exploratory analyses from TRANSCEND CLL 004.

William G. Wierda

Oral

Abstract #S158

Sunday, June 16, 2024

6:30 AM – 7:45 AM (11:30 – 12:45 CET)

Multiple Myeloma (MM)

Disease characteristics and survival outcomes in patients with relapsed and refractory multiple myeloma by extramedullary disease status: findings from the Connect MM disease registry.

Hans Lee

Poster

Abstract #P930

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Safety and preliminary efficacy of BMS-986393, a GPRC5D CAR T cell therapy, in patients with relapsed/refractory (RR) multiple myeloma (MM) and 1-3 prior regimens: First results from a phase 1 study.

Omar Nadeem

Poster

Abstract #P951

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Idecabtagene vicleucel (ide-cel) in patients (pts) with clinical high-risk early relapse multiple myeloma (MM) without front-line (1L) autologous stem cell transplantation (ASCT): KarMMa-2 cohort 2b.

Xavier Leleu

Oral

Abstract #S208

Saturday, June 15, 2024

11:30 PM – 12:45 PM (16:30 – 17:45 CET)

Association of patient factors and pharmacodynamic biomarkers with progression-free survival after idecabtagene vicleucel in patients from KarMMa-3.

Bertrand Arnulf

Poster

Abstract #P876

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Iberdomide is immune stimulatory and induces deep anti-myeloma activity across doses in combination with daratumumab in patients with TNE NDMM from the CC-220-MM-001 study.

Michael Amatangelo

Poster

Abstract #P847

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Mezigdomide (mezi), tazemetostat (taz), and dexamethasone (dex) in patients (PTS) with relapsed/refractory multiple myeloma (RRMM): Preliminary results from the CA057-003 trial.

Luciano Costa

Poster

Abstract #P903

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Improved disease status pre-infusion leads to better outcomes with standard of care idecabtagene vicleucel (ide-cel) in patients with relapsed refractory multiple myeloma (RRMM).

Aimaz Afrough

Poster

Abstract #P939

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Myelodysplastic Syndromes (MDS)

Real-world dose escalation and outcomes among patients with lower-risk myelodysplastic syndromes receiving luspatercept in clinical practice.

Kashyap Patel

Poster

Abstract #P768

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Quantifying the relationship between transfusion independence and overall survival in lower-risk myelodysplastic syndromes.

Luca Malcovati

Poster

Abstract #P782

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Value of early luspatercept use in lower-risk myelodysplastic syndromes (LR-MDS).

David Valcárcel

Poster

Abstract #P789

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Relationship between haemoglobin and quality of life in transfusion-dependent patients with lower-risk myelodysplastic syndrome receiving luspatercept or epoetin alfa.

Esther Oliva

Poster

Abstract #P774

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Luspatercept improves hematopoiesis in lower-risk myelodysplastic syndromes (MDS): Comparative biomarker analysis of ring sideroblast-positive and -negative subgroups from the phase 3 COMMANDS study.

Sheida Hayati

Poster

Abstract #P763

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Clinical benefit of luspatercept in transfusion-dependent, erythropoiesis-stimulating agent-naive patients with very low-, low- or intermediate-risk myelodysplastic syndromes in the COMMANDS trial.

Valeria Santini

Poster

Abstract #P785

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Multilineage and safety results from the COMMANDS trial in transfusion-dependent, erythropoiesis-stimulating agent-naive patients with very low-, low- or intermediate-risk myelodysplastic syndromes.

Guillermo Garcia-Manero

Poster

Abstract #P780

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Comparative analysis of clinical benefit by genomic landscape and mutational burden of luspatercept versus epoetin alfa in lower-risk myelodysplastic syndromes (MDS) in the Phase 3 COMMANDS study.

Rami S Komrokji

Poster

Abstract #P749

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Myelofibrosis

Patient characteristics, treatment patterns, and health outcomes in a real-world population of patients with myelofibrosis treated with fedratinib.

Francesco Passamonti

Poster

Abstract #P1034

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Fedratinib inhibits immune evasion and restores B cell maturation: Biomarker analysis from the FREEDOM2 study.

Claire Harrison

Poster

Abstract #P1020

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Non-Hodgkin Lymphoma (includes DL B CL, LBCL, FL, MCL, etc.)

Safety and efficacy of golcadomide, a potential first-in-class CELMOD agent ± rituximab in a phase 1/2 open-label study of patients with relapsed/refractory (r/r) follicular lymphoma (FL).

Julio Chavez

Poster

Abstract #P1132

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Golcadomide (Golca [CC-99282]), a novel CELMoD agent, plus R-CHOP in patients (pts) with untreated aggressive B-cell lymphoma (A-BCL): Updated safety and 12-month efficacy results.

Marc Hoffmann

Oral

Abstract #S235

Friday, June 14, 2024

9:45 AM – 11:00 AM (14:45 – 16:00 CET)

Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by ASCT as second-line treatment in patients with R/R large b-cell lymphoma: 3-year follow up of TRANSFORM.

Jeremy Abramson

Oral

Abstract #S272

Sunday, June 16, 2024

6:30 AM – 7:45 AM (11:30 – 12:45 CET)

Subgroup analyses in patients with R/R MCL treated with lisocabtagene maraleucel by prior lines of therapy and response to bruton tyrosine kinase inhibitor from the TRANSCEND NHL 001 MCL cohort.

Manali Kamdar

Poster

Abstract #P1126

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Thalassemia (Alpha or Beta)

Safety data from the dose-finding cohorts: a phase 2A study of luspatercept in pediatric patients with βeta-thalassemia.

Antonis Kattamis

Poster

Abstract #P1516

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

Characterizing patterns of transfusion burden (TB) reduction in patients (pts) with transfusion-dependent (TD) βeta-thalassemia treated with luspatercept in the BELIEVE trial.

Kevin Kuo

Poster

Abstract #P1522

Friday, June 14, 2024

1:00 PM – 2:00 PM (18:00 – 19:00 CET)

All EHA (Free EHA Whitepaper) abstracts, except late-breaking abstracts, will be available at 10:00 AM EDT on May 14. All late-breaking abstracts will be available at 10:00 AM EDT on June 3.

On May 23, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer will present at the 2024 Leerink Partners Healthcare Crossroads Conference on Wednesday, May 29, 2024, at 8:40 a.m. CDT (Press release, Bio-Techne, MAY 23, 2024, View Source [SID1234643581]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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