On June 13, 2026 Eli Lilly and Company (NYSE: LLY) reported new data from the Phase 1 AJX-101 study showing that its investigational type II JAK2 inhibitor (AJ1-11095) demonstrated an encouraging safety profile and promising clinical activity in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor. This first-in-class type II JAK2 inhibitor was designed to selectively bind the type II conformation of the JAK2 kinase in order to potentially provide greater efficacy than existing therapies and a novel treatment option for patients who become resistant to type I JAK2 inhibitors. Lilly recently added this program to its pipeline following the completion of the acquisition of Ajax Therapeutics, Inc.

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These data will be highlighted in an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting taking place in Stockholm, Sweden (Abstract number: S218) and featured in the meeting’s press program.

"Patients with myelofibrosis who have been previously treated with an existing type I JAK2 inhibitor face very limited treatment options, highlighting an urgent need for new therapies," said John Mascarenhas, MD, professor of medicine, Icahn School of Medicine at Mount Sinai and principal investigator of the AJX-101 study. "These early clinical findings suggest that selective targeting of the type II conformation of JAK2 may provide a differentiated approach. With an encouraging safety profile, meaningful spleen size reduction, symptom improvement, and decrease in underlying mutant disease burden, these data, while early, point to the potential to meaningfully impact treatment options for people with certain myeloproliferative neoplasms."

AJX-101 is the first clinical trial to evaluate a type II selective JAK2 inhibitor in patients with myelofibrosis. The trial enrolled 23 patients across five dose levels (25, 50, 75, 100, and 125 mg once daily) in its dose escalation phase. Patients had received a median of two prior therapies, and all had previously received a type I JAK2 inhibitor. The trial enrolled patients across all major myelofibrosis subtypes and driver mutations.

AJ1-11095 demonstrated responses across the standard efficacy endpoints of spleen volume reduction and symptom improvement.1 The SVR35 rate, a reduction in spleen volume of at least 35%, was observed as best response in 70% of patients. The TSS50 rate, indicating at least a 50% improvement in symptom burden, was also seen in 70% of patients at week 12. In addition, reductions in driver mutation variant allele frequency (VAF) were observed in 21 out of 23 patients. Among the 17 patients who reached week 24 of treatment, 59% saw a reduction of 20% or greater and 35% saw a reduction of 50% or greater, including JAK2, MPL, and CALR type 1 and type 2 mutations. VAF reductions are uncommonly observed with existing type I JAK2 inhibitors.2

The overall safety profile for the medicine was generally manageable. No dose-limiting toxicities were observed, and most patients enrolled in the dose escalation phase remain on study (78%).3 The most common treatment-emergent adverse events across all dose levels included anemia, dysgeusia, decreased platelet count, and increased alanine aminotransferase.

"The depth of response seen across spleen, symptoms, and VAF from these early phase results is in excess of what has been seen historically in this disease setting," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "These data provide clear proof of concept for what this selective type II JAK2 inhibitor could mean for patients with myelofibrosis and shed light on the conviction we brought to the acquisition of Ajax. With this program now officially part of Lilly’s pipeline, we are committed to rapidly advancing it through clinical development and further exploring its potential to meaningfully improve outcomes for people with myeloproliferative neoplasms across a range of disease settings."

AJ1-11095 is currently being evaluated in an expansion cohort in second-line myelofibrosis, with plans to investigate in patients with high-risk polycythemia vera and those with myelofibrosis who have not yet received a JAK2 inhibitor. Details on the AJX-101 trial can be found by visiting clinicaltrials.gov.

About AJ1-11095
AJ1-11095 is an investigational, oral, first-in-class type II JAK2 inhibitor. AJ1-11095 is designed to bind JAK2 in its inactive conformation — an approach intended to more completely suppress the aberrant signaling that drives myelofibrosis, in contrast to currently approved JAK2 inhibitors that bind JAK2 in its active state. AJ1-11095 demonstrated superior activity compared to ruxolitinib in preclinical models of myelofibrosis. AJ1-11095 is currently being studied in AJX-101, a global, open-label, multicenter, Phase 1 study in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who have previously been treated with a type I JAK2 inhibitor, NCT06343805.

(Press release, Eli Lilly, JUN 13, 2026, View Source [SID1234668722])

On June 13, 2026 Genmab A/S (Nasdaq: GMAB) reported new data from two studies evaluating epcoritamab, a T-cell engaging antibody administered subcutaneously, in the first-line (1L) treatment of patients with diffuse large B-cell lymphoma (DLBCL) who may have limited treatment options due to advanced age or multiple health conditions. Results from the Phase 2 EPCORE DLBCL-3 study showed an overall response rate (ORR) of 67% and a complete response (CR) rate of 58% with epcoritamab monotherapy in elderly patients with newly diagnosed DLBCL. In the Phase 1b/2 EPCORE NHL-2 study, epcoritamab plus rituximab plus dose-attenuated cyclophosphamide, doxorubicin, vincristine, and prednisone (R-mini-CHOP) demonstrated an ORR of 93% and a CR rate of 86% in elderly patients with newly diagnosed DLBCL.

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The results from both studies were presented in two poster presentations (abstracts PS2082 and PF1007) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress held in Stockholm, Sweden, June 11-14. Additionally, the full EPCORE DLBCL-3 results have been simultaneously published in The Lancet Haematology.

EPCORE DLBCL-3 Results
The Phase 2 EPCORE DLBCL-3 study (abstract PS2082) evaluated the efficacy and safety of fixed-duration epcoritamab monotherapy in newly diagnosed CD20+ large B-cell lymphoma (LBCL) patients ineligible for anthracycline-based chemotherapy due to age (≥80 years) or comorbidities (≥75 years with comorbidities). Among 66 enrolled patients, the median age was 82.5 years, and all had comorbid conditions (94% with ≥3 comorbidities). With a median follow-up of 21.9 months, epcoritamab monotherapy demonstrated responses in this population with high unmet medical need.

An ORR of 67% and a CR rate of 58% were observed in evaluable patients (n=66). Median time to response was 1.5 months, and median time to CR was 2.2 months. Notably, 11 of 17 patients with a partial response or stable disease at first assessment subsequently achieved a CR.

"For newly diagnosed elderly patients with diffuse large B-cell lymphoma and comorbidities, who are often excluded from standard curative chemotherapy and ineligible for doxorubicin, finding more options is paramount," said Umberto Vitolo, M.D. Candiolo Cancer Institute, FPO-IRCCS, Candiolo (Turin), Italy. "The EPCORE DLBCL-3 study showed that epcoritamab monotherapy offers robust data. Importantly, its safety profile, including cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome, was consistent with expected rates in this fragile population with a high unmet medical need for new therapeutic options."

Responses were durable, with median duration of response (DOR) and duration of complete response (DOCR) not reached. At 12 months, an estimated 67% of responses and 73% of CRs remained ongoing. Median progression-free survival (PFS) was 13.0 months, while median overall survival (OS) was not reached; an estimated 43% of patients remained progression-free and 62% were alive at 18 months. High rates of minimal residual disease (MRD) negativity were observed, with 92% of evaluable responders achieving MRD negativity, typically by Cycle 3 Day 1 and sustained through Cycle 12 Day 1 in most patients.

The safety profile was consistent with expected rates in this elderly population. Cytokine release syndrome (CRS) occurred in 71% of patients, most commonly during Cycle 1, and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 18%. Infections of any grade occurred in 68% of patients (26% Grade ≥3), and neutropenia was reported in 16%, with no febrile neutropenia or clinical tumor lysis syndrome observed. Eight Grade 5 TEAEs occurred.

EPCORE NHL-2, Arm 8 Results
Arm 8 of the Phase 1b/2 EPCORE NHL-2 study (abstract PF1007) evaluated epcoritamab plus R-mini-CHOP in 28 newly diagnosed CD20+ DLBCL patients ineligible for full-dose R-CHOP due to age (≥75 years) or comorbidities (≥65 years with comorbidities). With more than two years of follow-up, fixed-duration epcoritamab plus R-mini-CHOP demonstrated high response rates, sustained MRD negativity and durable remissions.

An ORR of 93% and a CR rate of 86% were observed. Median DOR, DOCR, PFS, and OS were not reached. At two years, estimated DOR and DOCR rates were 79%, while estimated PFS and OS rates were 76% and 82%, respectively.

"The EPCORE NHL-2 Arm 8 results are very encouraging, showing that combining epcoritamab with R-mini-CHOP led to high overall response rates and complete response rates, rapid and sustained minimal residual disease negativity, and durable remissions in this population," said David Belada, M.D., Department of Internal Medicine—Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic. "These outcomes, alongside a consistent safety profile, potentially support the integration of epcoritamab with standard of care for these vulnerable patients, and highlight its broad utility in combinations across a range of disease settings and patient populations."

Rapid and sustained MRD negativity was observed, with 95% of evaluable patients achieving MRD negativity, including high rates in high-risk subgroups. Outcomes compared favorably with historical results for R-mini-CHOP alone.

The safety profile was consistent with prior reports and the known safety profiles of epcoritamab and R-mini-CHOP. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (54%), serious infections (33%) and anemia (14%). Most Grade ≥3 serious infections occurred during the first six cycles of treatment with R-mini-CHOP coadministration. TEAEs led to epcoritamab discontinuation in three patients (11%).

"Genmab is committed to evaluating epcoritamab as a potential treatment option in earlier lines of therapy for patients who traditionally struggle with aggressive treatment," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "The robust data observed in both the monotherapy and combination approaches reinforce our vision of making epcoritamab a foundational therapy across the spectrum of B-cell malignancies. These Phase 2 results support our ongoing commitment to addressing the significant unmet medical needs of elderly and comorbid patients, as we seek to identify effective, less intensive and tolerable options."

About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.i,ii DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.iii,iv DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,v

About the EPCORE DLBCL-3 Trial
EPCORE DLBCL-3 (NCT05660967) is an open-label, randomized, global, Phase 2 trial to evaluate the efficacy and safety of epcoritamab as monotherapy or in combination with lenalidomide as first-line therapy for anthracycline-ineligible subjects with diffuse large B-cell lymphoma (DLBCL). This is a 2-stage trial. In Stage 1, eligible patients were randomized to either epcoritamab monotherapy or epcoritamab plus lenalidomide. In Stage 2, additional patients were enrolled to the epcoritamab monotherapy arm. Each treatment cycle is 28 days. Patients will receive a maximum of 12 cycles (up to 1 year) of treatment. The primary objective is to evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide. The primary endpoint is to achieve a complete response rate determined by Lugano criteria. Additional secondary endpoints include overall response rate, duration of response, duration of complete response, rate of minimal residual disease negativity, progression-free survival and overall survival.

More information on this trial can be found at www.clinicaltrials.gov/.

About the EPCORE NHL-2 Trial
EPCORE NHL-2 (NCT04663347) is a Phase 1b/2 open-label interventional trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and in combination with other standard of care agents in patients with B-cell non-Hodgkin lymphoma (B-NHL). The trial consists of two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The primary objective of Part 1 is safety, and the primary goal of Part 2 is preliminary efficacy. The primary efficacy endpoint is overall response rate (ORR) based on best overall response per Lugano criteria. MRD negativity was assessed as a secondary endpoint.

More information on this trial can be found at www.clinicaltrials.gov.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. 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. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, JUN 13, 2026, View Source [SID1234668719])

On June 12, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported updated data from multiple clinical programs to be presented at the EHA (Free EHA Whitepaper) Annual Meeting in Stockholm, Sweden. Data from the RALLY-MF trial of DISC-0974 in patients with MF and anemia, to be presented in an oral session today, demonstrate meaningful, durable overall anemia responses across all patient subgroups, regardless of baseline transfusion status or concomitant JAK inhibitor use. Updated data from the HELIOS open-label extension trial of bitopertin in EPP, to be presented in a poster session tomorrow, June 13, show sustained reductions in PPIX, significant improvement in light tolerance measures, and favorable longer-term safety in patients treated with bitopertin.

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"The updates at this year’s EHA (Free EHA Whitepaper) highlight continued progress across our portfolio heading into a catalyst-rich second half of the year," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "For DISC-0974 in MF anemia, our Phase 2 dataset continues to strengthen as we prepare for End of Phase 2 discussions with FDA by the end of this year. For bitopertin, continued durability of PPIX reduction and light tolerance improvement in HELIOS is encouraging leading up to the APOLLO Phase 3 readout in Q4, which, as confirmed in a recent Type A meeting with FDA, can serve as the basis for a response to the CRL and could potentially support a traditional approval if successful. We also look forward to sharing initial data from the RESTORE-PV Phase 2 trial of DISC-3405 in polycythemia vera in Q4 this year, setting up the potential for a third program in pivotal-stage development in 2027."

Management will host a call following the EHA (Free EHA Whitepaper) meeting to review highlights of the presented data and next steps for the company on Monday, June 15 at 8:00am EDT. Please register for the event on the Events and Presentations page of Disc’s website (View Source).

Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.

Details of Presentations and Abstracts:

DISC-0974: RALLY-MF Oral Presentation

RALLY-MF, an ongoing Phase 2 open-label study, had enrolled 61 adult patients with MF and anemia as of the data cutoff date of April 27, including 50 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=31), transfusion dependent with low transfusion burden (TD Low, n=11) and transfusion dependent with high transfusion burden (TD High, n=8)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=25) and not receiving JAK inhibitor therapy (n=25). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. The updated results demonstrated:

Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron
55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and 68% had an increase of ≥1 g/dL for ≥12 weeks (overall response)
64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and 73% achieved a ≥50% reduction in transfusions (overall response)
50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and 88% achieved a ≥50% reduction in transfusion requirement (overall response)
56% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response across transfusion groups and 72% achieved an overall response, with similar response rates regardless of which specific JAK inhibitor the patient received
Dosing with DISC-0974 was associated with improvements in patient-reported outcomes:
Clinically significant improvements in FACIT-Fatigue scores in nTD and TD Low participants that were correlated with hemoglobin change
MPN-SAF TSS50 at EOS was achieved by 50% of nTD and TD low major responders
DISC-0974 was generally well-tolerated. Diarrhea, not considered serious, was the only adverse event (AE) that was reported as related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.

Bitopertin: HELIOS update poster

HELIOS is an ongoing Phase 2, open-label, long-term extension trial that enrolled 86 adult and adolescent patients with EPP from the BEACON and AURORA trials. Patients were randomized to receive 20 mg or 60 mg bitopertin in BEACON and 20 mg or 60 mg bitopertin or placebo in AURORA, with all patients transitioning to a 60 mg daily dose of bitopertin in HELIOS.

Longer term treatment with bitopertin was associated with sustained reductions in the disease-causing toxin PPIX, with additional benefit for patients receiving the 60 mg dose continuously
Treatment with bitopertin was associated with sustained, significant improvement in average light tolerance and time to prodrome measures
Bitopertin exhibited a favorable longer-term safety profile with up to 2.5+ years of exposure and similar safety across adults and adolescents with EPP and XLP
DISC-3405: RESTORE-PV Trial-in-Progress poster

RESTORE-PV is a Phase 2 open-label study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of DISC-3405 in patients with polycythemia vera. Initial data from the trial is expected in Q4 2026.

(Press release, Disc Medicine, JUN 12, 2026, View Sourcenews-releases/news-release-details/disc-medicine-presents-positive-clinical-updates-2026-european [SID1234668733])

On June 12, 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 new safety data from the ongoing Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in the second-line (2L) and third- and later-line (3L+) settings and new translational data for ronde-cel. The new data will be presented today in two poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden.

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"The clinical data presented today reinforce the differentiated profile of ronde-cel in more than 100 patients with relapsed or refractory large B-cell lymphoma," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "The updated safety profile, with no Grade 3 or higher CRS and low rates of Grade 3 or higher ICANS, supports outpatient administration. The translational data extend our understanding of ronde-cel’s durable clinical responses. Our data indicate they are achieved through next-generation dual-antigen targeting and production of CD62L-enriched CAR T-cells with enhanced memory phenotype."

Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma: Updated Safety Analysis (Poster: PF962)

A total of 108 patients with R/R LBCL (43 2L and 65 3L+) were treated with ronde-cel in the ongoing Phase 1/2 trial as of the data cutoff date of May 5, 2026. The population reflected high-risk disease: median age 64 years (range, 20 to 87), 67% (72/108) with primary refractory disease, and 28% (30/108) had an International Prognostic Index score of 3 or 4. Of the patients treated, 59% (64/108) received dexamethasone prophylaxis, 10 mg daily for three days at the time of CAR T-cell administration.

Key Safety Findings:

Cytokine Release Syndrome (CRS): There were no reports of Grade ≥ 3 events in patients treated with or without dexamethasone prophylaxis. Grade 1 CRS events were reported in 56% (36/64) and Grade 2 in 13% (8/64) of patients receiving prophylaxis, compared with cases of Grade 1 CRS reported in 30% (13/44) or Grade 2 in 39% (17/44) of patients who did not receive prophylaxis.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Grade ≥ 3 events of ICANS occurred in 8% (5/64) of patients receiving prophylaxis vs. 16% (7/44) of patients who did not receive prophylaxis. Grade 1 events were reported in 6% (4/64) and Grade 2 in 2% (1/64) of patients receiving prophylaxis vs. 11% (5/44) or 5% (2/44) who did not receive prophylaxis.
With over 100 patients treated, ronde-cel continues to show a consistent and manageable safety profile, supporting the potential for outpatient administration. Notably, dexamethasone prophylaxis did not change ronde-cel cell expansion and pharmacokinetics. Manufacturing has also proven reliable to date, with a 97% success rate across these patients.

Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR
T-Cells) Are Associated with Higher Proportion of Cytotoxic T Cells with Memory Potential in Infusion Products (Poster: PF1097)

The purpose of this study was to explore the roles of CD62L+ enrichment and CD19/CD20
dual-targeting in ronde-cel infusion products on clinical response observed in patients with R/R LBCL.

Single-cell RNA sequencing was conducted on ronde-cel infusion products to assess memory potential of cytotoxic effector cells compared to FDA-approved CD19 CAR T-cell therapies. Cluster analysis identified a population of cytotoxic effector cells (defined by high GZMB, IFNG, CCL4, CCL5, KLRD1 gene expression) that had higher expression of memory-associated genes (CD62L, IL7R, LEF1) compared to an analogous cytotoxic cluster from FDA-approved CD19 CAR T-cell therapies. These cells co-expressing cytotoxic genes and memory-associated genes are referred to as Cytotoxic T cells with Memory Potential (Tcmp) in this study.

Key Translational Findings:

Tcmp cells were more abundant in the ronde-cel products of patients with durable responses (>12 months) than in patients with progressive disease
Ronde-cel drug product Tcmp cells have a stronger memory potential compared to
axicabtagene ciloleucel’s cytotoxic effector cells
Ronde-cel Tcmp cells following CD62L enrichment also had higher survival and expansion in vitro compared to cytotoxic effector cells with CD4/CD8 enrichment.
Ronde-cel CAR+ T cells collected from patients two months after infusion sustained the capacity to proliferate, kill tumor cells, and secrete cytokines
Durable complete responses > 12 months observed in patients with LBCL with low CD19 or CD20 antigen expression on tumor biopsies at baseline
Collectively, these data offer a potential biological rationale for the benefits of CD62L+ enrichment during manufacturing and CD19/CD20 dual-targeting, which are thought to underpin the high rates of durable complete responses previously reported with ronde-cel.

Ronde-cel is currently being evaluated for the treatment of R/R LBCL across two pivotal clinical trials. In the 3L+ setting, the ongoing single-arm PiNACLE trial is expected to report updated data in the second half of 2026 and pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in the second half of 2027. In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel.

(Press release, Lyell Immunopharma, JUN 12, 2026, View Source [SID1234666615])

On June 12, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that the VENTANAⓇ PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (FDA) approval for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAPⓇ (capivasertib).

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"Prostate cancer is one of the leading cancer diagnoses for men in the United States," said Matt Sause, CEO of Roche Diagnostics. "The FDA approval of our new companion diagnostic will provide clinicians with a vital tool to identify patients with PTEN loss and potentially provide new therapeutic options."

PTEN is a tumour suppressor protein and loss of PTEN is commonly observed in a variety of cancers.2 Roche’s test enables patients with PTEN-deficient prostate cancer to potentially benefit from a combination treatment with TRUQAP. TRUQAP provides a new, first-line treatment option for patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC).3

Metastatic hormone-sensitive prostate cancer is an aggressive form of prostate cancer and treatments specifically targeting the PTEN protein loss biology were previously not available. The average length of survival after new, metastatic prostate cancer diagnosis is about 5 to 6 years.4 About 25% of patients with metastatic hormone-sensitive prostate cancer have PTEN-deficient tumors as evaluated by immunohistochemistry (IHC).1

Foundation Medicine, an independent affiliate of the Roche Group, is one laboratory using the VENTANA PTEN (SP218) RxDx Assay companion diagnostic kit to help healthcare providers identify patients with PTEN protein loss.

About the VENTANA PTEN (SP218) RxDx Assay
The VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of PTEN protein in prostate adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with prostate adenocarcinoma who may be eligible for treatment with TRUQAP in combination with abiraterone acetate in accordance with the approved therapeutic product labeling.

The approval of the VENTANA PTEN (SP218) RxDx Assay is based on the results of the CAPItello-281 clinical study where it was used as the enrollment assay to identify patients whose tumours exhibited PTEN deficiency. The clinical cutoff for PTEN protein loss status is ≥ 90% of viable malignant cells with no specific cytoplasmic staining. PTEN protein loss status is based on the pathologist’s observation of an absence or presence of PTEN expression within prostate adenocarcinoma.5 Patients who received combination therapy with TRUQAP experienced a statistically significant and clinically meaningful reduction in disease progression.

(Press release, Hoffmann-La Roche, JUN 12, 2026, https://www.globenewswire.com/news-release/2026/06/12/3311289/0/en/roche-receives-fda-approval-for-the-first-companion-diagnostic-to-assess-pten-protein-in-people-living-with-prostate-cancer.html [SID1234666614])