On June 8, 2026 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application that covers the use of ibudilast (MN-166) in combination with an immune checkpoint inhibitor, specifically an anti-PD-1 antibody, for the treatment of glioblastoma. This patent allowance is expected to further strengthen the intellectual property position supporting the Company’s combination therapy development strategy.

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Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "This Notice of Allowance further strengthens our intellectual property estate for MN-166 in glioblastoma and supports continued evaluation of ibudilast-based combination strategies in this aggressive malignancy. The allowed claims encompass use in combination with anti-PD-1 antibodies across multiple treatment parameters, including dosing regimen, route of administration, and duration of therapy, which we believe is strategically important as we continue to assess the potential clinical utility of MN-166 in oncology. Given the persistent unmet need in glioblastoma, we believe this patent position provides important support for the ongoing development of rational combination approaches intended to improve therapeutic outcomes."

Once issued, this patent is expected to expire no earlier than September 2042. The allowed claims cover not only the combination of ibudilast with multiple anti-PD-1 antibodies, but also a broad range of treatment conditions, including duration of administration, dosing frequency, route of administration, dose levels, and dosing schedules.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

(Press release, MediciNova, JUN 8, 2026, https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-notice-allowance-new-patent-covering-use-mn [SID1234666484])

On June 8, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported an update on the safety profile of LYL273 in its ongoing U.S. Phase 1 clinical trial in patients with relapsed or refractory metastatic colorectal cancer (mCRC), and announced the Phase 1 trial has been amended to enable seamless expansion into a potential pivotal single-arm Phase 2 trial pending regulatory alignment.

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LYL273 is a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. A 50% overall response rate across Dose Levels 1 and 2 has been previously reported (data cutoff date of October 28, 2025) in third- or later-line (3L+) relapsed or refractory mCRC patients in the U.S. Phase 1 clinical trial. The FDA has granted LYL273 Fast Track designation for the treatment of mCRC.

"The substantial reduction of Grade 2 or higher diarrhea or colitis, and absence of Grade 3 or higher CRS and ICANS in patients treated under our gastrointestinal prophylaxis and standardized safety management plan suggest we can manage the safety profile of LYL273 in patients with relapsed or refractory metastatic colorectal cancer," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "We are continuing to move forward to selection of the recommended Phase 2 dose and are on track for an End-of-Phase 1 meeting with the FDA by the end of the year."

Updated Safety Data from U.S. Phase 1 Clinical Trial Evaluating LYL273 in Patients with Relapsed or Refractory Third- or Later-Line mCRC

Nineteen patients have been enrolled in the U.S. Phase 1 clinical trial across Dose Levels 1 and 2 (1 and 2 x 106 CAR+ cells/kg) as of the data cutoff date of May 5, 2026. Ten of these patients were enrolled under the new gastrointestinal (GI) prophylaxis regimen including infliximab, vedolizumab and budesonide, along with a standardized safety management plan. Notably, the GI prophylaxis and standardized safety management plan reduced Grade > 2 diarrhea or colitis from 55% to 10% in patients without (N = 9) and with (N = 10) GI prophylaxis, respectively. These ten patients did not experience Grade ≥ 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). No additional adverse events of interest have been identified. There was no difference observed in GCC-CAR+ cell expansion either in terms of maximum cell expansion or area under the curve in those patients who received GI prophylaxis and those who did not.

Dose escalation continues in the U.S. Phase 1 clinical trial; the maximum tolerated dose has not been determined.

Phase 1 Clinical Trial Amended to Phase 1/2 Design

The U.S. Phase 1 clinical trial evaluating LYL273 in relapsed or refractory 3L+ mCRC has been amended to a Phase 1/2 design (CARABINER). The amended design enables seamless expansion into a potential pivotal single-arm Phase 2 trial once the recommended Phase 2 dose has been determined, subject to discussions with the U.S. Food and Drug Administration (FDA). New centers are being added to the trial in preparation for initiating the dose expansion portion of the Phase 1/2 trial.

The Phase 1 portion of the clinical trial includes four dose-escalation cohorts at Dose Levels 1 through 4 (1, 2, 3, 4 x 106 CAR+ cells/kg). Each dose-escalation cohort is designed to include three or six patients, with up to twenty-four patients across the four dose-escalation cohorts.

In addition to the existing 3L+ cohorts, the amendment adds new cohorts, including a second-line cohort and a cohort evaluating a combination strategy with radiotherapy. Up to sixty patients are expected to be enrolled across the new cohorts. The Phase 2 portion will expand enrollment at the recommended Phase 2 dose in an open-label, single-arm cohort.

Upcoming LYL273 Milestones

In the second half of 2026, additional Phase 1 clinical data, including clinical outcomes, and an End-of-Phase 1 meeting with the FDA are expected.

(Press release, Lyell Immunopharma, JUN 8, 2026, View Source [SID1234666501])

On June 8, 2026 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported the pricing of an underwritten public offering of common stock and pre-funded warrants. IDEAYA is selling 5,555,556 shares of common stock and pre-funded warrants to purchase 5,555,576 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $27.00 per share, before underwriting discounts and commissions, and the pre-funded warrants are being sold at a public offering price of $26.9999 per pre-funded warrant. The exercise price of the pre-funded warrants is $0.0001 per share. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,666,669 shares of its common stock at the public offering price per share, before underwriting discounts and commissions. The aggregate gross proceeds to IDEAYA from this offering are expected to be approximately $300.0 million, before deducting underwriting discounts and commissions and other offering expenses, and excluding the exercise of any pre-funded warrants. The offering is expected to close on or about June 10, 2026, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Jefferies, TD Cowen, UBS Investment Bank, and Cantor are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for this offering.

The securities described above are being offered by IDEAYA pursuant to an automatically effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission, or the SEC. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; TD Securities, by mail at TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; UBS Investment Bank, by mail at UBS Securities LLC, 11 Madison Avenue, New York, NY 10010, Attention: Equity Syndicate, or by email at [email protected]; or Cantor, by mail at Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Ideaya Biosciences, JUN 8, 2026, View Source [SID1234666485])

On June 8, 2026 Photocure ASA (OSE: PHO), the Bladder Cancer Company, and Artera, a leading precision medicine company, reported launch of a joint research initiative. The collaboration encompasses Photocure’s blue light cystoscopy (BLC) registry in bladder cancer and the ArteraAI Bladder Test, an AI-powered digital pathology test currently in development for patients with bladder cancer.

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As healthcare systems increasingly embrace precision medicine, the demand for advanced precision diagnostics in uro-oncology continues to grow. Photocure, already recognized for its proven leadership in bladder cancer diagnostics where accuracy is critical, is well positioned to meet this need. This research initiative with Artera underscores Photocure’s commitment to grow an array of complementary diagnostic solutions to address the evolving needs of patients, physicians, and the broader healthcare community, towards more personalized, data-driven care in uro-oncology, enabling better clinical outcomes and supporting the shift toward precision medicine.

The research collaboration will provide Artera with access to high-quality data from the Photocure U.S. BLC registry to further validate the ArteraAI Bladder Test. Together, the companies will utilize real world evidence to help urologists more effectively identify bladder cancer and manage its treatment. Unlike many other cancers, there are fewer well-established biomarkers in bladder cancer, which currently limits clinicians from personalizing treatment options. The partnership between Photocure and Artera is dedicated to advancing research that guides smarter treatment decisions and helps patients receive therapies best suited to their disease.

The objectives of using the BLC registry’s long-term clinical practice data are to develop, evaluate, and optimize the performance of Artera’s multimodal AI (MMAI) histopathology biomarkers in patients with non-muscle invasive bladder cancer (NMIBC). The joint research aims to validate the prognostic and predictive capabilities of the ArteraAI Bladder by addressing critical clinical questions.

"With this collaboration, we are exploring additional ways to enter scientific collaborations that may utilize Photocure’s BLC registry to advance the field of precision diagnostics. When urologists use BLC, they often perform biopsies and resection to achieve a more accurate diagnosis and a more complete procedural outcome. By pairing the BLC captured specimen with the ArteraAI Bladder Test, we aim to accurately determine the grade and stage of disease while also providing a readout on whether these patients are optimal candidates for specific follow-up drug therapy. BLC and Artera’s AI-powered biomarkers have the promise to set patients on the right course of bladder cancer management, streamlining the decision-making for pathologists and urologists," said Anders Neijber, Chief Medical Officer of Photocure.

"Artera is excited to be working with Photocure to expand the application of our MMAI algorithms into other genitourinary cancers. Given the impact we’ve made to date in the prostate cancer realm, we hope to make a similar impact in bladder cancer and deliver personalized prognostic and predictive insights to patients and physicians," said Andre Esteva, co-founder and CEO of Artera.

"Building on the success of BLC, Photocure is expanding its vision to develop a complementary suite of precision diagnostic solutions. With established expertise, relationships and a track record in bladder cancer, we are uniquely placed to drive progress and set new standards in the future of uro-oncology precision diagnostics. Today we are seeking to accelerate the advancement of personalized care in a manner that has not previously been achieved. Along with Artera, we are truly excited about what we can do for urologists, their staff and their patients," said Dan Schneider, President and CEO of Photocure.

(Press release, PhotoCure, JUN 8, 2026, View Source [SID1234666486])

On June 8, 2026 AbbVie (NYSE: ABBV) reported it will share new data at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress and will showcase clinical advancements from research programs across multiple blood cancers, including multiple myeloma (MM), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and amyloidosis (AL). Featured data from AbbVie’s blood cancer portfolio and pipeline include 21 oral and poster presentations, highlighting the investigational compound etentamig (ABBV-383), and approved therapies, EPKINLY (epcoritamab-bysp) (TEPKINLY in the EU), VENCLEXTA (venetoclax) (VENCLYXTO in the EU) and DECNUPAZ (pivekimab sunirine-pvzy).

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"The compelling data we are presenting at EHA (Free EHA Whitepaper) reflect AbbVie’s robust portfolio and pipeline and our ongoing work to advance the treatment and understanding of hematologic cancers," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "With this research, we continue our commitment to pioneering innovative solutions that have the potential to elevate standards of care for patients and help address the most pressing challenges in treating blood cancers."

Key oral presentations of epcoritamab data include:

Treatment impact of epcoritamab with lenalidomide and rituximab in relapsed or refractory (R/R) FL
A subgroup analysis of the Phase 3 EPCORE FL-1 trial (NCT05409066) of fixed-duration epcoritamab, in combination with rituximab plus lenalidomide (E+R2) for patients with R/R FL (n=243), was performed to determine if the efficacy benefit and tolerability of E+R2 extended across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared to R2.1
Between Follicular Lymphoma International Prognostic Index (FLIPI) subgroups, overall response rate (ORR) was numerically higher with E+R2 compared to R2 (FLIPI 0–2, 96.5% vs 84.8%; FLIPI 3–5, 93.0% vs 72.6%).1 A similar trend was seen in those with progression of disease less than or equal to two years from the date of initial frontline therapy (POD24).1
Across the age subgroups, ORR and complete response rates (CRR) for E+R2 and R2 for ≥65 were (94.3% vs 80.2% and 80.7% vs 44.3%, respectively) and <65 (95.5% vs 78.4% and 83.9% vs 54.0%, respectively). Progression-free survival (PFS) hazard ratios (HRs) (95% CIs) for E+R2 and R2 for the NHL-5 low co-morbidity index score were (0.27 [0.17–0.42]) and NHL-5 high + intermediate were (0.14 [0.06–0.29]).1
The E+R2 safety profile across all subgroups was consistent with the overall trial population, with no new safety signals.1
Efficacy data of epcoritamab following systemic therapy in R/R large B-cell lymphoma (LBCL)
EPCORE DLBCL-1 (EudraCT No. 2020-003016-27) is a randomized Phase 3 trial in R/R LBCL evaluating epcoritamab, a CD3×CD20 bispecific antibody, monotherapy. The study showed a statistically significant improvement in PFS versus investigator’s choice of chemoimmunotherapy (CIT) — either rituximab plus gemcitabine plus oxaliplatin or bendamustine plus rituximab (HR 0.74 [95% CI, 0.60–0.92]; P=0.0059; 24-month PFS: 30% vs 13%). The study did not demonstrate a statistically significant improvement in overall survival (OS) (HR: 0.96 [95% CI, 0.77–1.20]). There was no OS detriment per pre-specified criteria.*2
Epcoritamab reported a CRR of 38% and CIT 26%; (nominal P value 0.0032), duration of response (DOR) (median DOR 37 vs 6 months; duration of complete response (DOCR) NR vs 11 months, respectively) and time to next treatment (TTNT) (7 vs 4 months, respectively; nominal P value <0.0001).2
Higher rates of grade 3–4 infections (30% vs 12%) and any-grade COVID-19 (36% vs 11%) were reported in the epcoritamab arm. Grade 5 treatment-emergent adverse events (TEAEs) occurred in 17% vs 6% (exposure-adjusted, 1.5 vs 1.8 per 100 pt-mo) and were largely attributable to grade 5 COVID-19 (9% vs 2%).2
*OUS the protocol and SAP were amended to include dual primary endpoints of OS and PFS

The following studies featuring venetoclax, etentamig and pivekimab sunirine-pvzy data will also be shared as oral and poster presentations:

Predicted efficacy of venetoclax-based therapies in CLL based on genetic biomarkers
Results from the Phase 3 GAIA/CLL13 (NCT02950051) trial evaluating fixed-duration venetoclax-based combinations (with rituximab, obinutuzumab and obinutuzumab plus ibrutinib) as a chemotherapy-free alternative to chemoimmunotherapy (fludarabine, cyclophosphamide and rituximab or bendamustine and rituximab) in fit, previously untreated CLL patients lacking del(17p) or TP53 mutations.3
Venetoclax in combination with rituximab and obinutuzumab plus ibrutinib in previously untreated CLL patients lacking del(17p) or TP53 mutations are investigational combinations not approved in the EU.
Efficacy and safety data of venetoclax-obinutuzumab combination in previously untreated CLL
Results from the open-label Phase 3 CLL14 trial (NCT02242942) comparing the efficacy and safety of venetoclax in combination with obinutuzumab to obinutuzumab plus chlorambucil in previously untreated patients with CLL and coexisting medical conditions.4
Real-world management practices with venetoclax-based therapy for AML
Results from the prospective observational study, REVIVE (NCT03987958), examining the effect of antimicrobial prophylaxis, post-remission administration of G-CSF and treatment initiation setting on safety and effectiveness outcomes with venetoclax plus hypomethylating agents (HMA) in newly diagnosed AML patients unfit for intensive chemotherapy.5
Etentamig in patients with relapsed/refractory multiple myeloma (RRMM) with prior exposure to B-cell maturation antigen (BCMA)-targeted therapy
Results from Arm B of the MONVISO study (NCT05650632), evaluating a flat dose of etentamig in patients with RRMM with at least two prior lines of therapy, including triple-class and prior BCMA exposure. The Phase 1b study is assessing dose optimization and safety.6
Etentamig is an investigational therapy not approved in the EU.
Longer term safety and efficacy data of etentamig monotherapy in R/R light chain amyloidosis
Updated results from M24-209 (NCT06158854), evaluating etentamig monotherapy in BCMA-targeted therapy-naïve patients with relapsed/refractory immunoglobulin light chain amyloidosis. The open-label Phase 1/2 study is assessing dose escalation safety and efficacy.7
Etentamig is an investigational therapy not approved in the EU.
Efficacy data of pivekimab sunirine-pvzy in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) with baseline skin involvement in the CADENZA study
Post-hoc analysis from CADENZA (NCT03386513), evaluating the first-line use of pivekimab sunirine-pvzy in patients with BPDCN and varying degrees of skin involvement. The open-label Phase 1/2 study is assessing overall response rate, overall survival and percentage of eligible patients approved to proceed with a stem cell transplant.8
Pivekimab sunirine-pvzy is an investigational therapy not approved in the EU.
Details on key oral and poster presentations at the EHA (Free EHA Whitepaper) 2026 Congress are available below and the full abstracts are available here.

Oral Presentations:

Title

Date/Time

Session

Abstract/ Presentation Number

Clinically Relevant Subgroup Analysis from the Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect of Epcoritamab with Lenalidomide and Rituximab (R2) in R/R Follicular Lymphoma (FL)

Thursday, June 11,

17:45 – 18:00 CEST

Oral Session,

K1 Hall

EHA-3041

Short: S229

Results from EPCORE DLBCL-1: Randomized Phase 3 Study of Epcoritamab (Epcor) Vs Investigator’s Choice Chemoimmunotherapy (CIT) in Patients with Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL)

Friday, June 12,
17:15 – 17:30 CEST

Oral Session,

Nobel Hall

EHA-2409

Short: S235

Venetoclax-obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Final Results of the Randomized CLL14 Study

Friday, June 12,

17:30 – 17:45 CEST

Oral Session,

AE1 Hall

EHA-2488

Short: S146

Genetic Biomarkers Predicting Sustained Efficacy of Venetoclax-based Therapies or CIT in Chronic Lymphocytic Leukemia: Final 5-year Analysis of the GAIA/CLL13 Trial

Friday, June 12,
18:15 – 18:30 CEST

Oral Session,

AE1 Hall

EHA-4841

Short: S149

Phase 1 Dose Escalation Safety and Efficacy of Etentamig in Patients with Relapsed or Refractory Light Chain Amyloidosis

Friday, June 12,
18:15 – 18:30 CEST

Oral Session,

Victoria Hall

EHA-1134

Short: S209

Fixed Duration Venetoclax Plus Epcoritamab Shows Favorable Tolerability and High Response Rates with Early Molecular Responses in R/R CLL/SLL: Interim Analysis of the Randomized HOVON 165/AETHER Trial

Sunday, June 14,
11:45 – 12:00 CEST

Oral Session,

A10-11 Hall

EHA-3784

Short: S153

Poster Presentations:

Sustained Remissions Beyond 4 Years with Epcoritamab Monotherapy: Long-term Follow-up Results from the Pivotal EPCORE NHL-1 Trial in Patients with Relapsed or Refractory Large B-cell Lymphoma

Friday, June 12,
18:45 CEST

Poster Session, Hall A

EHA-2191

Short: PF977

Epcoritamab + R-mini-chop Results In 2-year Remissions and High MRD-negativity Rates in Elderly Patients with Newly Diagnosed DLBCL: Results from the EPCORE NHL-2 Trial

Friday, June 12,
18:45 CEST

Poster Session,

Hall A

EHA-2359

Short: PF1007

Reduced CD20 Expression and Intratumoral CD3+ T Cells Following Epcoritamab Treatment Are Associated with Progressive Disease in a Subset of Diffuse Large B-cell Lymphoma and Follicular Lymphoma

Friday, June 12,
18:45 CEST

Poster Session, Hall A

EHA-2343

Short: PF1069

Pharmacodynamic Biomarkers Support the Clinical Benefit of Epcoritamab Plus Rituximab and Lenalidomide (R2) In Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Analyses from EPCORE FL-1

Friday, June 12,
18:45 CEST

Poster Session, Hall A

EHA-3123

Short: PF1081

Real-world Management Practices with Venetoclax-based Therapy For AML – Results from the Prospective REVIVE Study

Friday, June 12,
18:45 CEST

Poster Session,

Hall A

EHA-3291

Short: PF536

The Efficacy of Pivekimab Sunirine (PVEK) in Patients (PTS) with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) with Baseline Skin Involvement in the CADENZA Study

Friday, June 12,
18:45 CEST

Poster Session,

Hall A

EHA-1950

Short: PF500

Anchored Matching-adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab Vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 Vs Inmind

Saturday, June 13,
18:45 CEST

Poster Session, Hall A

EHA-1124

Short: PS2035

Comparative Effectiveness of Epcoritamab, Lenalidomide, and Rituximab in EPCORE FL-1 Vs Real-world Chemoimmunotherapy in Relapsed/Refractory Follicular Lymphoma

Saturday, June 13,
18:45 CEST

Poster Session, Hall A

EHA-3065

Short: PS2042

Comparative Analyses of Epcoritamab in Combination with Lenalidomide and Rituximab Vs Obinutuzumab and Bendamustine in Relapsed/Refractory Follicular Lymphoma

Saturday, June 13,
18:45 CEST

Poster Session, Hall A

EHA-3140

Short: PS2052

Epcoritamab + Chemoimmunotherapy in Patients with Relapsed/Refractory Large B-cell Lymphoma Eligible for Autologous Stem Cell Transplant: Pooled Results from Arms 4 and 10 of EPCORE NHL-2

Saturday, June 13,
18:45 CEST

Poster Session,

Hall A

EHA-2303

Short: PS2070

Fixed-duration Epcoritamab Monotherapy Induces High Response and MRD-negativity Rates in Elderly Patients with Newly Diagnosed Large B-cell Lymphoma and Comorbidities: Results from EPCORE DLBCL-3

Saturday, June 13,
18:45 CEST

Poster Session, Hall A

EHA-2346

Short: PS2082

Epcoritamab In Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL): Insights from the Real-world Epcoritamab Patient Characteristics and Outcomes Research (Real-epcor) Study

Saturday, June 13,
18:45 CEST

Poster Session, Hall A

EHA-2202

Short: PS2086

Epcoritamab Plus Lenalidomide and Rituximab Improves or Preserves Health-related Quality of Life in Patients with Relapsed/Refractory Follicular Lymphoma Who Had High Symptom Burden or Adverse Events

Saturday, June 13,
18:45 CEST

Poster Session, Hall A

EHA-2776

Short: PS2497

Quality of Life and Symptoms with Fixed-duration Acalabrutinib + Venetoclax ± Obinutuzumab Vs Chemoimmunotherapy in Treatment-naive Chronic Lymphocytic Leukemia: Patient-Reported Outcomes from AMPLIFY

Saturday, June 13,
18:45 CEST

Poster Session,

Hall A

EHA-4662

Short: PS1706

Etentamig In Patients (PTS) with Relapsed/Refractory Multiple Myeloma (RRMM) with Prior Exposure to B-cell Maturation Antigen (BCMA)-targeted Therapy

Saturday, June 13,
18:45 CEST

Poster Session,

Hall A

EHA-2799

Short: PS1913

Etentamig (ABBV-383) is an investigational medicine and is not approved by any health authorities worldwide. The safety and efficacy of this medicine is under evaluation as part of ongoing clinical studies. Pivekimab sunirine is not approved in the EU.

EPKINLY/TEPKINLY (epcoritamab) and VENCLEXTA/VENCLYXTO (venetoclax) are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses.

EPKINLY/TEPKINLY (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

VENCLEXTA/VENCLYXTO (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

Additional information on AbbVie clinical trials is available at View Source

USE & IMPORTANT SAFETY INFORMATION for EPKINLY (epcoritamab-bysp) in U.S.

What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with:

certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments.
follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab
follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments.
EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY.

It is not known if EPKINLY is safe and effective in children.

IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side effects, including:

Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems.

People with FL may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems.

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.

EPKINLY can cause other serious side effects, including:

Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion.
Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets.

The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Full Prescribing Information and Medication Guide, including Important Warnings.

Globally, prescribing information varies. Refer to the individual country product label for complete information.

USE & IMPORTANT SAFETY INFORMATION for VENCLEXTA (venetoclax tablets) in U.S.

Uses

VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
‒ are 75 years of age or older, or
‒ have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you get any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you get symptoms of TLS. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may check again for your risk of TLS and change your dose.

Who should not take VENCLEXTA?

Patients taking certain medicines during the beginning of VENCLEXTA (when the dose is being slowly increased) are at increased risk of TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby.
Females who are able to become pregnant:
‒ Your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA.
‒ Use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA.
‒ If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit during treatment with VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Your healthcare provider will do blood tests to check your blood count during treatment with VENCLEXTA and may pause dosing of VENCLEXTA or give you medicines to help treat your neutropenia if it is severe.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you get a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you get a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with acalabrutinib in people with CLL or SLL include low white blood cell count, headache, diarrhea, muscle and bone pain, and COVID-19.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

Your healthcare provider may temporarily stop VENCLEXTA treatment, decrease your dose, or completely stop treatment if you get severe side effects.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

Please see full Prescribing Information. Globally, prescribing information varies. Refer to the individual country product label for complete information.

U.S. Prescribing Information for AbbVie Medicines

Please see full Prescribing Information including BOXED WARNING for DECNUPAZ (pivekimab sunirine-pvzy)

(Press release, AbbVie, JUN 8, 2026, View Source [SID1234666487])