On June 15, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported positive interim Phase 1 clinical data for its CLDN6 x CD3 T cell engaging bispecific antibody, CTIM-76, in advanced, late-line platinum-resistant ovarian cancer ("PROC"). The data are as of a May 29, 2026 data cutoff from the ongoing CTIM-76 Phase 1 study.

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"We are encouraged by the continued development of CTIM-76 as a potentially best-in-class CLDN6 T cell engager that may offer a much-needed new therapeutic approach for patients with platinum-resistant ovarian cancer," said Martin Lehr, Chief Executive Officer of Context. "In our first clinical presentation of dose-escalation data, weekly administration of CTIM-76 produced compelling anti-tumor activity and a well-tolerated safety profile in heavily pretreated patients, many of whom had extensive prior exposure to antibody-drug conjugates. Building on this encouraging data, we have advanced into the next phase of development, where we will evaluate CTIM-76 administered every three weeks ("Q3W"). These results are expected to inform subsequent Phase 1b dose expansion in 2027."

CTIM-76 Phase 1a Interim Data Summary:

21 patients with PROC (n=14), testicular (n=4), and endometrial (n=3) cancer were treated with CTIM-76 at doses ranging from 22.5µg to 560µg every week ("QW").
At the active doses of 140µg to 280µg, 13 patients were treated in total, 10 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff.
560µg exceeded target exposures with QW dosing and was not pursued further.
PROC Patient Characteristics:

Patients (n=9) received a median of 7 prior lines of therapy (range 5-16).
Prior patient treatments included ADC (89%), checkpoint inhibitor (55%), VEGF (100%), or DNA repair agent (78%).
44% of patients had liver metastases.
Efficacy Results:

As of the data cutoff, 7 PROC patients were efficacy-evaluable at doses of 140µg to 280µg.
Overall response rate (ORR): 29% of PROC patients (2/7) achieved confirmed partial RECIST v. 1.1 responses.
Disease control rate (DCR)1: 57% (4/7)
In early cohort patients who achieved confirmed stable disease or partial response, treatment durability was sustained for at least 6 months (n=3).
Safety Results:

At active dose levels, CTIM-76 produced a favorable safety profile that is consistent with the expected mechanism of action for a T cell engager and supports continued clinical development.
Adverse events generally occurred during the first or second dose and were predominantly low grade, with the majority of events reported as Grade 1 or Grade 2 and reversible with standard management.
CRS events were infrequent and limited to Grade 1 (11%, n=1/9) at active dose levels in PROC patients, which may be supportive of outpatient dosing in future trials.
Pharmacokinetic Results:

Approximately dose-dependent increases in CTIM-76 exposure with increasing dose level.
Preliminary PK supports exploration of Q3W dosing schedule.
Investor Webcast and Conference Call Information
The Company will host a conference call to discuss these data at 8:00 a.m. ET today, June 15, 2026. Participants may access the live webcast of the conference call from the "News & Events" page of the Company’s website at www.contexttherapeutics.com. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. The webcast will be available for replay for at least 90 days on the Company’s website.

About CTIM-76
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on View Source

(Press release, Context Therapeutics, JUN 15, 2026, View Source [SID1234668753])

On June 15, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, reported first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The results are being presented today in a late-breaking session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (Abstract #LB5006).

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In the ongoing Phase 1 study, a single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion. At the higher dose level (DL2), LB2501 achieved a 100% objective response rate (ORR) (6/6) and an 83.3% complete response rate (CR) (5/6), with all responses ongoing at the time of data cutoff. LB2501 also showed a favorable safety profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths reported.

"In vivo CAR-T represents a compelling frontier in cell therapy, enabling the generation of CAR-T cells directly within the patient, with the potential to simplify treatment and expand access over time," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "LB2501 is our step toward realizing that vision and reflects further progress toward our goal of leading the future of cell therapy. Backed by the commercial and scientific foundation we have built with CARVYKTI, we are well-positioned to advance this next generation of CAR-T delivery. These early data, with deep responses from a single infusion across patients, give us confidence in the path ahead."

LB2501 Demonstrates In Vivo CAR-T Generation and Early Clinical Activity

In an ongoing Phase 1 study, 12 patients with R/R B-NHL received LB2501 across two dose levels, DL1 (n=6) and DL2 (n=6). Patients had received a median of three prior lines of therapy, and 58.3% were refractory to their most recent treatment. The open-label, multi-center, dose-escalation study is evaluating safety, recommended Phase 2 dose, pharmacokinetics, and preliminary efficacy in adults with R/R B-NHL. The study was conducted without lymphodepletion.

At DL2, LB2501 achieved a 100% ORR (6/6) and an 83.3% CR rate (5/6), with responses observed across patients with diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Across both dose levels, the ORR was 50.0% (6/12), and the CR rate was 41.7% (5/12). At the time of data cutoff, all responses at DL2 were ongoing.

LB2501 showed a favorable safety profile. No DLTs, SAEs, ICANS, or deaths were reported. Infusion-related reactions (IRR) and cytokine release syndrome (CRS) were the most common adverse events of special interest and were all Grade 1–2. Infusion-related reactions occurred in 75.0% (9/12) of patients overall, with a median onset of 1.4 hours after infusion and a median recovery time of 18.6 hours. CRS occurred in 66.7% (8/12) of patients overall, with a median onset at Day 11 and a median duration of 4.5 days. IRR and CRS were all Grade 1–2, no patients required glucocorticoids for CRS management. Four patients received tocilizumab.

Pharmacokinetic analyses showed dose-dependent in vivo CAR-T expansion in 100% (6/6) of patients at DL2 and 83% (5/6) of patients at DL1. CAR-T cells remained detectable in peripheral blood for up to 116 days. Viral copy number in peripheral blood peaked immediately after infusion and decreased to undetectable concentrations within 24 hours.

Additional translational analyses further characterized the in vivo profile of LB2501. No evidence of non-specific transduction was detected in NK cells or other non-T/B/NK lymphocyte populations. Vector integrations were highly polyclonal and diverse. These findings support proof-of-concept for in vivo T-cell engineering, with polyclonal vector integration and rapid vector clearance.

"These early clinical findings are encouraging in a heavily pretreated relapsed or refractory B-cell non-Hodgkin lymphoma population," said Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China. "The responses observed at the higher dose level achieved a 100% objective response rate, together with a favorable safety profile and the absence of lymphodepletion, support further investigation of LB2501 as a novel in vivo CAR-T approach. The additional pharmacokinetic and translational findings presented at EHA (Free EHA Whitepaper) further support the feasibility of generating CAR-T cells directly within the patient." ‡

ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study (NCT07002112) in patients with relapsed/refractory B-cell malignanciesi to assess safety, tolerability, and preliminary efficacy.[i]

ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.iii

While treatment advances have improved outcomes for some patients, those with relapsed or refractory B-cell NHL, particularly after multiple lines of therapy, often face limited options.

(Press release, Legend Biotech, JUN 15, 2026, View Source [SID1234668752])

On June 15, 2026 CERo Therapeutics Holdings, Inc. (OTCQB: CERO) ("CERo" or the "Company"), an innovative cellular immunotherapy company advancing engineered T cell therapeutics designed to engage phagocytic mechanisms, reported a clinical update from investigators participating in the ongoing Phase 1 CERTAIN-T clinical trial evaluating CER-1236 in hematologic malignancies.

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Patient five in the trial had multiple refractory acute myeloid leukemia (AML) and, according to the treating investigator, had not previously achieved disease control sufficient to enable allogeneic stem cell transplantation prior to enrollment in the study. Following treatment with CER-1236 at a total dose of 4 million cells/kg, bone marrow blast counts were reported at 14% on Days 14 and 28 and 7% on Day 42. The patient subsequently underwent allogeneic stem cell transplantation on Day 71 following infusion. Allogeneic stem cell transplantation is generally considered a potentially curative therapeutic option for eligible patients with refractory hematologic malignancies and remains a critical component of treatment for many patients with relapsed or treatment-resistant disease.

The patient’s transplant course and longer-term clinical outcome remain under evaluation. These observations are preliminary, based on a limited number of patients, and no definitive conclusions regarding safety or efficacy can be made at this stage of the trial.

Chris Ehrlich, CEO of CERo, commented, "We continue to observe encouraging findings from the ongoing trial, with investigators reporting clinical improvement in two patients treated across the first two cohorts. Although formal response assessments remain ongoing, investigators have reported findings suggestive of clinical benefit following treatment with CER-1236. We look forward to continuing dose escalation and further evaluating CER-1236 in the ongoing Phase 1 study."

The observed safety profile across all treated patients remains consistent with clinical data previously presented at the Tandem Meetings in February, which reported no cytokine release syndrome ("CRS"), immune effector cell-associated neurotoxicity syndrome ("ICANS"), DLTs, or treatment-related severe adverse events during the DLT assessment window.

The Company has now treated six patients in the ongoing Phase 1 trial. In the most recent cohort of three patients, CER-1236 was administered at an increased dose level, with no dose-limiting toxicities ("DLTs") observed during the DLT assessment period. As previously reported, CERo has also observed expansion of infused CER-1236 cells following administration, and the Company continues to evaluate the pharmacokinetic and pharmacodynamic profile of CER-1236 as the study advances through dose escalation.

The Company has initiated the third planned cohort of the CERTAIN-T study, which is expected to evaluate the planned one billion cells/patient protocol and is currently screening patients for enrollment. The cohort is also expected to include patients with myelodysplastic syndromes ("MDS") and myelofibrosis ("MF"), reflecting the Company’s strategy to further evaluate CER-1236 in additional myeloid disease settings.

About the CERTAIN-T Trial

The first-in-human, multicenter, open-label Phase 1/1b CERTAIN-T study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of CER-1236 in patients with hematologic malignancies. The study initially enrolled patients with acute myeloid leukemia ("AML"), including relapsed/refractory AML, measurable residual disease AML, and newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent myelodysplastic syndromes ("TD-MDS"), high-risk myelodysplastic syndromes ("HR-MDS"), and post-JAK inhibitor myelofibrosis ("MF"). Primary endpoints include safety and tolerability. Secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate ("ORR"), complete response ("CR"), composite complete response ("cCR"), and measurable residual disease ("MRD").

(Press release, Cero Therapeutics, JUN 15, 2026, View Source [SID1234668751])

On June 15, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB) ("Alvotech" or the "Company"), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported the pricing of its previously announced underwritten public offering (the "Offering") of 22,666,667 of its ordinary shares at an offering price of $3.75 per share. All ordinary shares to be sold in the Offering will be offered by Alvotech. The Offering is expected to close on or about June 17, 2026, subject to satisfaction of customary closing conditions. The Company has also granted the underwriters a 30-day option to purchase up to an additional 3,400,000 ordinary shares at the public offering price, less underwriting discounts and commissions. Before deducting the underwriting discounts and commissions and offering expenses, the Company expects to receive total gross proceeds of approximately $85 million from the Offering, or approximately $98 million if the underwriters exercise in full their option to purchase additional shares.

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Concurrent with the Offering, Alvotech has entered into Subscription Agreement(s) with certain investors that are professional clients or eligible counterparties in the European Economic Area falling within article 1(4) of Regulation (EU) 2017/1129, pursuant to which Alvotech will issue and sell 17,826,666 ordinary shares to such investors at a price of $3.75 per ordinary share, which represents the per share public offering price, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended. The gross proceeds from the concurrent private placement, before deducting any transaction-related expenses, are expected to be approximately $67 million. The concurrent private placement is expected to close on or about June 25, 2026, subject to the consummation of the Offering and other customary conditions. However, the consummation of the Offering is not contingent on the consummation of the concurrent private placement.

The total gross proceeds from the Offering and the concurrent private placement are expected to be approximately $152 million, or approximately $165 million if the underwriters exercise in full their option to purchase additional shares, in each case before deducting underwriting discounts and commissions and estimated offering expenses payable.

Alvotech intends to use the net proceeds from this Offering and the concurrent private placement to fund the continued development of its biosimilar assets, as well as working capital and general corporate purposes, which may include, among others, intellectual property protection and enforcement, commercial expenditures, capital expenditures, acquisitions or collaborations, pre-clinical and clinical development of its product candidates, research and development and product development, pre-commercialization activities and repayment or refinancing of indebtedness or other corporate borrowings.

BofA Securities, Jefferies and Evercore ISI are acting as joint book-running managers for the Offering.

The Offering is being made pursuant to a registration statement on Form F-3, including a base prospectus, that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on October 20, 2023, and declared effective on October 30, 2023. The ordinary shares referred to in this press release are being offered in the United States only by means of a prospectus supplement and the accompanying prospectus that forms a part of the registration statement. Copies of the final prospectus supplement and the accompanying prospectus related to this Offering may be obtained, when available, from: BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255-0001, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

(Press release, Alvotech, JUN 15, 2026, View Source [SID1234668750])

On June 15, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that over 40 clinical studies of the Company’s novel BTK inhibitor orelabrutinib were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. Clinical data on the efficacy and safety of orelabrutinib in treatment-naïve (TN) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients from the United States and Europe was released for the first time.

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A series of clinical studies on orelabrutinib covered multiple hematological malignancies, including CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and primary central nervous system lymphoma (PCNSL). These findings further support the excellent efficacy and safety of orelabrutinib.

Poster Presentation:

1. Orelabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Safety and Efficacy Results from a Global Phase 1/2 Study. (No. PF610)

This study is to evaluate the safety and efficacy of orelabrutinib in patients with CLL/SLL from the United States and Europe. The researchers include multiple world-renowned oncology centers such as Mayo Clinic. Results are consistent with the prior report in Chinese patients, confirming the efficacy and safety of orelabrutinib for CLL/SLL in a global population.

In evaluable TN CLL/SLL patients (median follow-up 38.1 months), ORR was 100%, with 36-month PFS rate at 94.4% and 36-month OS rate at 100% respectively.

In evaluable R/R CLL/SLL patients (median follow-up 36.8 months), ORR was 86.7%, with 36-month PFS rate 77.9% and the 36-month OS rate 80.1% respectively.

Orelabrutinib demonstrates high kinase selectivity, alleviates off-target inhibition, and reduces cardiovascular, bleeding, and hematologic adverse events.

2. Long-term Follow-up of Orelabrutinib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (No. PF949)

With long-term follow-up, orelabrutinib demonstrated rapid and durable responses, indicating sustained therapeutic benefit in patients with r/r MZL. Importantly, no new safety signals were observed during extended follow-up.

At a median follow-up of 36.8 months, the investigator-assessed ORR was 58.9%, median PFS was 44.4 months, and the 36-month OS rate was 84.7%.

3. Risk-Adapted Management with Obinutuzumab and Orelabrutinib with or without Lenalidomide in Untreated Marginal Zone Lymphoma: First Report of a Prospective, Phase II, Multi-Centre (MAGIC) Study (No. PS2037)

This is a prospective, phase II, multicenter study. The preliminary results demonstrated encouraging efficacy and a manageable safety profile in patients with previously untreated MZL.

Patients with an MZL-IPI score of 0–2 received obinutuzumab plus orelabrutinib (O2 regimen). Those with a score of 3–5 received obinutuzumab, orelabrutinib and lenalidomide (RO2 regimen). In patients who completed six cycles of induction therapy, the CRR was 85.7% and ORR was 95.3% in the O2 group, and the CRR was 71.4% and ORR was 85.7% in the RO2 group.

The study is ongoing, and updated efficacy and safety data will be reported in due course.

4. Polatuzumab Vedotin Combined with Orelabrutinib and Rituximab (PRO Regimen) as Frontline Therapy in Very Elderly and Frail Patients with DLBCL: Updated Results from a Phase II Study (No. PS2072)

Results support the PRO regimen, which includes orelabrutinib, as a feasible strategy for vulnerable patients.

Patients had a median age of 78 years. At the completion of combination therapy, the CR rate was 91.7%. With a median follow-up of 7.0 months, neither the median PFS nor the median OS has been reached. The estimated 9-month PFS rate was 92.8%.

Most other hematologic and non-hematologic toxicities were confined to Grade 1-2 and were clinically manageable with supportive care.

5. The Real-World Efficacy of Bruton’s Tyrosine Kinase Inhibitors Plus High-Dose Methotrexate-Based Induction Treatment for Untreated Primary CNS Lymphoma: A Single-Center Retrospective Analysis (No. PF1035)

This analysis aims to evaluate the efficacy of BTKi like orelabrutinib plus HD-MTX-based chemotherapy regimens as induction treatment for newly diagnosed PCNSL patients in a real-world cohort. The results show that the ORR after induction treatment was 88.6% and the CR rate was 81.1%. There was no significant difference in PFS among the three BTKi, but a significant improvement in OS was observed in the orelabrutinib group (HR 0.26, P = 0.016). These results support the use of BTKi-containing treatment regimens as a first-line therapy for PCNSL in clinical practice.

More studies on orelabrutinib have been accepted for poster presentations at the 2026 EHA (Free EHA Whitepaper) Congress. Details are listed below:

Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab Followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (No. PF959)
Efficacy, Safety, and Genetic Analysis of Orelabrutinib Combined with Rituximab as First-Line Systemic Treatment for Marginal Zone Lymphoma (No. PF951)
Preliminary Analysis of Orelabrutinib Combined with Obinutuzumab for Marginal Zone Lymphoma (ORION Study) (No. PS2050)
Preliminary Results of Orelabrutinib Followed by Response-Adapted Ultra-Low-Dose 4Gy Radiotherapy as First-Line Treatment for Localized MALT Lymphoma: A Prospective, Open-Label, Phase II Study (No. PS2053)
Integrative Transcriptomic Profiling Reveals the Molecular Landscape and Regulatory Drivers of Blastoid Mantle Cell Lymphoma (No. PS1099)
Bruton Tyrosine Kinase Inhibitor Maintenance Therapy in First-Line Diffuse Large B-Cell Lymphoma: A Multicenter Real-World Study Challenging Conventional Paradigms (No. PS2127)
Orelabrutinib Plus R-CHOP for the Treatment of Newly Diagnosed Non-GCB Double-Expressor Diffuse Large B-Cell Lymphoma: A Multicenter, Single-Arm, Phase II Study (No. PS2075)
Large-Scale Real-World Clinical Characteristics and Efficacy of Diffuse Large B-Cell Lymphoma Across Distinct Molecular Subtypes: Interim Data from the BELIEVE Study (No. PF991)
Clinical Characteristics and Efficacy of MYC/BCL-2 Double-Expressing Diffuse Large B-Cell Lymphoma: Real-World Data from the BELIEVE Study (No. PS2103)
Orelabrutinib, Rituximab, and Thiotepa (ORT) With or Without High-Dose Methotrexate for Untreated Primary Central Nervous System Lymphoma (No. PS2088)
Efficacy and Safety of Orelabrutinib Combined with Sintilimab in Patients with Relapsed/Refractory Primary Central Nervous System Lymphoma (R/R PCNSL): A Prospective Multicenter Phase II Study (No. PS2130)
Orelabrutinib in Patients with Relapsed or Refractory Primary or Secondary Central Nervous System Lymphoma: A Multicenter, Open-Label, Phase II Study (No. PS2090)
Additionally, more than 20 studies on orelabrutinib were selected for online presentation.

The 2026 EHA (Free EHA Whitepaper) Congress is one of the most influential academic conferences in hematology and was held in Stockholm, Sweden.

(Press release, InnoCare Pharma, JUN 15, 2026, View Source [SID1234668749])