Imfinzi plus Imjudo combined with lenvatinib and TACE reduced the risk of disease progression or death by 30% in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial

On June 1, 2026 Astrazeneca reported positive results from the EMERALD-3 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE), demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation. Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, prior to TACE and then in combination with TACE thereafter.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

These results will be presented today in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (abstract #LBA4000).

In a planned interim analysis, the STRIDE regimen combined with lenvatinib and TACE demonstrated a 30% reduction in the risk of disease progression or death versus TACE alone (based on a PFS hazard ratio [HR] of 0.70; 95% confidence interval [CI] 0.57-0.86; p=0.0007). The median PFS was 13.0 months for this regimen versus 9.8 months for TACE. The PFS improvement was broadly consistent across key prespecified patient subgroups.

For the secondary endpoint of overall survival (OS), a positive trend was observed in favour of the STRIDE regimen with lenvatinib and TACE versus TACE alone (HR 0.84; 95% CI 0.65-1.09; p=0.1814).

Although not formally tested at this analysis, the key secondary endpoints of PFS and OS for the treatment arm evaluating the STRIDE regimen plus TACE versus TACE alone showed a clinically meaningful improvement in PFS (HR 0.71; 95% CI 0.56-0.91; nominal p=0.0062) and OS (HR 0.70; 95% CI 0.51-0.95; nominal p=0.0233) versus TACE alone. Median PFS was 12.9 months for STRIDE plus TACE versus 8.1 months for TACE alone.

In a pre-planned exploratory analysis comparing the two investigational arms, a PFS improvement was observed favouring the lenvatinib-containing arm in patients with non-viral aetiology (HR 0.70; 95% CI: 0.44-1.09). The trial will continue to assess OS and other key secondary endpoints in both investigational arms.

Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator in the trial said, "Patients with embolisation-eligible liver cancer face the burden of repeated localised therapy and are in urgent need of new systemic treatment options to delay disease progression and recurrence. The EMERALD-3 trial represents a meaningful advance for patients, with nearly one in three alive and progression-free at two years when treated with this dual immunotherapy regimen with or without lenvatinib, with a trend toward improved survival."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Building on practice-changing results from the HIMALAYA Phase III trial, these progression-free survival results and the early overall survival trend in the EMERALD-3 trial highlight the meaningful impact of bringing the STRIDE regimen into an earlier setting. These results advance our strategy to move novel immunotherapy regimens into earlier stages of cancer and underscore the opportunity to bring new treatment options for patients into this challenging liver cancer setting."

The safety profile for each combination was consistent with the known profiles of each medicine. Grade 3 or higher adverse events from all causes occurred in 71.4% of the patients in the STRIDE plus lenvatinib and TACE arm, and 64% of the patients in the STRIDE plus TACE arm, versus 28.6% in the TACE-only arm.

Summary of PFS and OS results: EMERALD-3


STRIDE + lenvatinib + TACE

(n=293)

TACE

(n=292)

STRIDE + TACE

(n=175)

TACE

(n=first 175)

PFS
Number of patients with event (%)

172 (58.7)

201 (68.8)

123 (70.3)

140 (80.0)

Median PFS (in months)

13.0 (12.2-16.7) i,ii

9.8 (8.0-11.4) i,ii

12.9 (10.2-15.9) iii,iv

8.1 (6.5-10.2) iii,iv

HR (95% CI)

0.70 (0.57-0.86) i

0.71 (0.56-0.91) iii, iv

P-value

0.0007 v

0.0062 vi

Data maturity

63.8% i

75.1% iii

PFS rate at 12 months (%)

56.2

42.9

53.0

38.0

PFS rate at 18 months (%)

42.1

30.8

38.8

29.8

PFS rate at 24 months (%)

30.4

19.3

30.0

20.3

OS
HR (95% CI) iii

0.84 (0.65-1.09)

0.70 (0.51-0.95) iv, vii

P-value

0.1814 v

0.0233 vi

Median OS (in months) iii

39.5 (34.1-NC)

34.7 (28.8-NC)

NC (37.7-NC) iv, viii

32.9 (24.1-43.2)

Data maturity iii

40.3%

45.4%

OS rate at 12 months (%) iii

83.2

82.0

87.7

81.5

OS rate at 18 months (%) iii

77.5

69.7

76.4

67.3

OS rate at 24 months (%) iii

66.9

61.5

68.0

57.8

NC, not calculable

i The data cut-off date was 02 Sep 2025

ii PFS was assessed by BICR per RECIST v1.1

iii The data cut-off date was 23 Feb 2026

iv Descriptive per the pre-specified multiplicity/hierarchy; no formal statistical inference is claimed

v Stratified log rank

vi Nominal

vii Estimated using a stratified Cox proportional hazards model

viii Calculated using the Kaplan-Meier technique; CI derived based on Brookmeyer-Crowley method

Notes

Liver cancer
Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death.1-2 In 2026, more than 200,000 patients will be diagnosed with embolisation-eligible HCC, with more than 180,000 in China and Japan alone.3 Embolisation is a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.4-5

Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings, including STRIDE.2

EMERALD-3
EMERALD-3 is a randomised, open-label, sponsor-blinded, multicentre, global Phase III trial of a single priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks (STRIDE regimen) plus TACE with or without lenvatinib versus TACE alone in a total of 760 patients with unresectable HCC eligible for embolisation.

Participants were randomised in a 1:1:1 ratio to Arm A (TACE, Imfinzi, Imjudo, lenvatinib), Arm B (TACE, Imfinzi, Imjudo) and Arm C (TACE) until each arm reached 175 participants. Randomisation was then continued in a 1:1 ratio to treatment Arms A and C until each reached approximately 275 participants. Patients received Imfinzi with Imjudo, plus TACE as needed, with or without lenvatinib concurrently, followed by Imfinzi with or without lenvatinib until progression.

The trial was conducted in 171 centres across 22 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS for Imfinzi plus Imjudo, lenvatinib and TACE versus TACE alone. Secondary endpoints include OS for Imfinzi plus Imjudo, lenvatinib and TACE, and PFS and OS for Imfinzi plus Imjudo and TACE versus TACE alone.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In gastrointestinal (GI) cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. In resectable gastric and gastroesophageal junction (GEJ) cancers, perioperative Imfinzi added to standard-of-care chemotherapy is approved in the US and EU.

In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC) based on results from the NIAGARA Phase III trial. Imfinzi is also approved in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in the US and Brazil for BCG-naïve, high-risk non-muscle-invasive bladder cancer based on the POTOMAC Phase III trial. In May 2026, perioperative Imfinzi with or without Imjudo plus neoadjuvant enfortumab vedotin (EV) met its dual primary endpoint of PFS for both regimens, treating patients with cisplatin-ineligible MIBC in the VOLGA Phase III trial. Perioperative Imfinzi plus neoadjuvant EV also achieved a significant OS benefit, a key secondary endpoint.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers.

Imjudo
Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across multiple tumour types including in SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).

AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.6

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic, and colorectal cancers.

Imfinzi, an anti-PDL1 antibody, is approved in combination with chemotherapy in locally advanced or metastatic BTC and in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Imfinzi is being assessed in combinations, including with Imjudo, in liver, BTC, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), is approved in the US and several other countries for HER2-positive advanced gastric cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

The Company is also assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, in combination with bevacizumab with or without Imjudo as a 1st-line treatment in patients with advanced HCC, and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. Rilvegostomig is also being evaluated in combination with Enhertu in previously untreated, HER2-expressing, locally advanced or metastatic BTC.

AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class ADC licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development; and AZD4360, an ADC, currently being evaluated in a Phase I/II trial in patients with advanced solid tumours.

In early development, AstraZeneca is developing AZD7003, a Glypican 3 (GPC3) armoured CAR T, in HCC.

(Press release, AstraZeneca, JUN 1, 2026, View Source [SID1234666324])

BeOne Medicines Highlights Accelerating Solid Tumor Pipeline with New Data at ASCO 2026

On June 1, 2026 BeOne Medicines Ltd. ("BeOne") (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported new data from its solid tumor pipeline being presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 29–June 2, Chicago). These data underscore the significant acceleration across the Company’s high-priority breast, gynecologic and gastrointestinal (GI) cancer development programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data from three differentiated BeOne pipeline assets will be presented, including:

CDK4 inhibitor (BGB-43395) (poster presentation): First disclosure of anti-tumor activity in first-line (1L) HR+/HER2- metastatic breast cancer.
B7-H4 ADC (BG‑C9074) (rapid oral presentation): Phase 1 dose-escalation and safety expansion data in advanced solid tumors.
GPC3x4-1BB (BGB-B2033) bispecific antibody (rapid oral presentation): First clinical data in advanced solid tumors, including hepatocellular carcinoma (HCC), the most common type of liver cancer.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said: "2026 is an inflection year for BeOne’s solid tumor portfolio, marked by the encouraging data we are presenting at ASCO (Free ASCO Whitepaper) combined with upcoming readouts at other major congresses. These programs validate our strategy of pairing the right biology with the right modality, and support advancing several assets in different indications into pivotal trials in 2026."

Selective CDK4 inhibitor shows promising efficacy and differentiated safety in first-line breast cancer (Poster Presentation: 180; June 1, 2026, 1:30 PM-4:30 PM CDT)
BeOne will present data about its highly selective CDK4 inhibitor, BGB-43395, in 1L HR+/HER2- metastatic breast cancer, in combination with letrozole, showing promising anti-tumor activity and a favorable safety profile, characterized by infrequent low-grade hematologic toxicities and manageable GI events, which were further mitigated when administered with food. Highlights include:

The 240 mg dose of BGB-43395 plus letrozole resulted in a confirmed overall response rate (ORR) of 68.4% (95% CI: 43.4–87.4) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).
The 400 mg dose plus letrozole resulted in a confirmed ORR of 63.2% (95% CI: 38.4–83.7) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).
Low levels of hematologic treatment-related adverse events (TRAEs) with Grade ≥3 neutropenia reported in 5.3% of patients at the 240 mg dose level and 0% at 400 mg, as well as low frequency of fatigue and asthenia; supports profile and validates the molecule’s high selectivity for CDK4.
GI TRAEs were mitigated when administered with food, all of which were Grade 1.
Median study follow-up was 12.5 (range, 3.1-15.2) months, 12.4 (range, 8.0-15.0) months, and 10.8 (range, 3.2-12.9) months for the 240 mg, 400 mg, and 600 mg dose groups, respectively.
These compelling safety and efficacy findings support the rationale to initiate a global, randomized Phase 3 clinical trial with BGB-43395 in combination with letrozole in 1L HR+/HER2- metastatic breast cancer. The trial, KANDELA-302 (NCT07492641), will begin enrolling patients this month.

B7-H4 ADC demonstrates encouraging efficacy supporting advancement in ovarian cancer (Rapid Oral Abstract: 3013; June 2, 2026, 9:45-11:15 AM CDT)
Data at ASCO (Free ASCO Whitepaper) from BeOne’s B7‑H4-targeting antibody-drug conjugate (ADC), BG‑C9074, include results from Phase 1 dose‑escalation and safety‑expansion cohorts, demonstrating a combination of early efficacy signals and a favorable tolerability profile. Highlights include:

At doses under consideration for future development, confirmed ORR of 45.5% and unconfirmed ORR of 54.5% in ovarian cancer (OC), and 40.0% in triple-negative breast cancer, with median study follow-up of 6.6 (range, 0.3-20.8) months.
Anti-tumor activity demonstrated in OC regardless of B7-H4 expression level.
Treatment was generally well tolerated with low rates of discontinuation at <5%; 31.5% of patients experienced Grade ≥3 TRAEs, with no Grade ≥3 nausea at 6 mg/kg adjusted ideal body weight (AIBW) and 1.2% at 8 mg/kg AIBW. Grade ≥3 neutropenia rates were 14.8% at 6 mg/kg AIBW and 34.6% at 8 mg/kg AIBW.
AIBW-based dosing used in the ongoing phase 1 study of BG-C9074 effectively reduced pharmacokinetic variability compared with total body weight dosing, as presented in a separate abstract (Poster 166) at ASCO (Free ASCO Whitepaper).
These results support continued advancement of the BG‑C9074 development program, with efforts focused on early‑line OC and additional B7‑H4-expressing tumor types.

Potential first-in-class GPC3x4-1BB bispecific demonstrates unprecedented anti-tumor activity in heavily pre-treated HCC patients (Rapid Oral Abstract: 3016; June 2, 2026, 9:45-11:15 AM CDT)
The first clinical data (Phase 1a) for BGB-B2033, a GPC3x4-1BB bispecific antibody, will be presented in a rapid oral session highlighting the first-in-class potential of this program in advanced solid tumors, including heavily pre-treated HCC. BGB-B2033 was rationally designed to target GPC3-expressing tumors, a protein commonly expressed in HCC, the sixth most prevalent cancer and third leading cause of cancer death worldwide,1 with five-year survival rates of only approximately 20%.2

Highlights include:

At doses ≥300 mg, confirmed ORR was 28.9% and unconfirmed ORR was 31.6%, with median study follow-up of 4.8 (range, 0.3-15.5) months.
Treatment was generally well tolerated across all dose levels (1-1000 mg every three weeks [Q3W], N = 61) with no significant dose-dependent increase in rates of treatment-emergent adverse events (TEAEs):
68.9% (42) of patients experienced TEAEs; of these:
47.5% (29) were treatment related
8.2% (5) of patients experienced Grade ≥3 TRAEs
4.9% (3) were treatment-related serious adverse events
TEAE leading to treatment discontinuation occurred in 3.3% (2) of patients
Dose limiting toxicity occurred in 1.6% (1) of patients
TRAEs that occurred in >5% of patients were limited to increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), both occurring at Grade ≥3 in only 1.6% of patients.
BGB-B2033

300 mg Q3W

(N=14)

600 mg Q3W

(N=14)

1000 mg Q3W

(N=10)

Confirmed ORR (complete response + partial response), n (%)

4 (28.6)

5 (35.7)

2 (20.0)

Unconfirmed ORR (complete response + partial response), n (%)

4 (28.6)

5 (35.7)

3 (30.0)*

*An additional PR (week 36) was reported at 1000 mg, with patient still on treatment, pending confirmation in the next tumor assessment

With ORR levels in heavily pretreated patients on par with the current first-line immunotherapy combination standard of care and a differentiated safety profile, BeOne is moving rapidly to advance clinical development of BGB-B2033. The Company has already announced the initiation of a potentially registration-enabling pivotal study in late-line HCC and planned expansion into earlier lines of therapy and additional tumor types, with the ambition to establish a new standard of care in this difficult-to-treat cancer.

Investor webcast to highlight solid tumor pipeline data at ASCO (Free ASCO Whitepaper)

BeOne will hold an investor webcast at 7:00 p.m. CDT/8:00 p.m. EDT, today, June 1, 2026. The Company’s leadership team, with clinical commentary by expert physicians, will highlight key solid tumor programs being presented at ASCO (Free ASCO Whitepaper), share progress in BeOne’s global R&D portfolio, and outline the strategies and capabilities supporting the Company’s continued growth trajectory.

Webcast access details are available in the Investors section of BeOne’s website at View Source, View Source, and View Source An archived webcast will be available on the Company’s website.

About BGB-43395, a CDK4 inhibitor
BGB-43395 is an investigational cyclin-dependent kinase (CDK) 4 inhibitor being studied in a global clinical development program in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The program includes KANDELA-302 (NCT07492641), a randomized Phase 3 clinical trial, initiated in Q2 2026 in first-line metastatic HR+/HER2- breast cancer. BGB-43395 is highly potent and selective CDK4 inhibitor and has the potential to reduce the dose-limiting hematologic toxicities that exist with the current CDK4/6 standard of care and may improve tolerability and enable deeper CDK4 inhibition.

About BG-C9074, a B7-H4-targeting ADC
BG-C9074, an investigational topoisomerase I inhibitor ADC that targets the B7-H4 protein, which is broadly expressed in breast and gynecologic cancers, is designed with an innovative drug linker to deliver a potent cancer-killing drug directly to the cancer cells. In a Phase 1 study of BG-C9074 (NCT06233942), patients with advanced solid tumors, irrespective of B7-H4 expression, received BG-C9074 every 3 weeks in escalating doses from 1 to 9 mg/kg. A subsequent safety expansion cohort received BG-C9074 in doses ranging from 4 to 8 mg/kg. Endpoints included safety, recommended dose for expansion, preliminary antitumor activity and pharmacokinetic measures.

About BGB-B2033, a GPC3x4-1BB bispecific antibody
BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in hepatocellular carcinoma (HCC),3 and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.4 The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity. BGB-B2033 is being investigated in a Phase 1 study (NCT06427941) in patients with GPC3-expressing advanced solid tumors with at least one prior line of therapy. Patients received BGB-B2033 every 3 weeks in eight escalating dose levels from 1 to 1000 mg, with various safety and anti-tumor activity endpoints. In December 2025, the FDA granted Fast Track Designation to BGB-B2033 for the treatment of HCC, followed by Orphan Drug Designation in March 2026.

(Press release, BeOne Medicines, JUN 1, 2026, View Source [SID1234666323])

Actinium Pharmaceuticals Presents New Radiochemistry Data at SNMMI 2026 Demonstrating That CAR Optimization Improves Tumor Targeting and Pharmacokinetics of Actinium-225 Radioconjugates

On June 1, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported new radiochemistry data at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting taking place in Los Angeles, California.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster presented a systematic evaluation of chelator-to-antibody ratio (CAR) optimization for Actinium-225 (225Ac)-labeled antibody radioconjugates, a critical but often underappreciated design parameter that directly influences radiolabeling efficiency, antigen binding, internalization, and biodistribution. The findings reinforce a proprietary radiochemistry capability that underpins the Company’s broader pipeline. Practically, CAR governs how many radioactive payloads each tumor-seeking antibody carries. Too few a payload causes a radioconjugate drug to under deliver, too many and the antibody loses its aim and leaks dose into healthy tissue. Therefore, identifying the optimal ratio is what separates a technically active therapy from one that can be dosed effectively and safely.

Sandesh Seth, Actinium’s Chairman and CEO, said, "Our CAR optimization data underscore the depth of our radiochemistry expertise and our focus on maximizing therapeutic index, which we believe is a key differentiator of our platform. Getting the chelator-to-antibody ratio right is fundamental to preserving the biological integrity of an antibody while enabling robust 225Ac labeling and favorable pharmacokinetics. These findings have direct implications for the design of next-generation radioconjugates, and reinforce a radiochemistry advantage that supports successful clinical translation across our pipeline."

Highlights from the SNMMI 2026 Poster Presentation
Poster Titled: Optimizing Chelator-to-Antibody Ratio Improves Tumor Targeting and Pharmacokinetics of 225Ac-Labeled Antibodies

Optimizing the chelator-to-antibody ratio (CAR) is a critical but often underappreciated design parameter in antibody-based radiopharmaceuticals. Actinium’s scientists conducted a systematic evaluation of CAR for 225Ac-labeled antibody radioconjugates, with findings directly applicable to the development of Actinium’s radiopharma pipeline:

Antibody-DOTA conjugates spanning CAR 0.7–9 were prepared. CAR ≥1.7 enabled robust 225Ac labeling, while CAR 0.7 was insufficient. This establishes the minimum loading needed to carry an effective radioactive dose

Antigen binding stayed high at low CAR (91–98% at CAR 0.7–3.2) but fell at high CAR (79–85% at CAR 7–9), and low-CAR conjugates internalized more, keeping more of the antibody functional. Median Fluorescence Intensity (MFI) is a proxy for binding or antigen affinity retention. Findings suggest overloading the antibody degrades its ability to find and enter cancer cells

In vivo, both conjugates showed comparable tumor uptake and sustained retention through 192 h, but the low-CAR (2.5) conjugate significantly reduced liver and spleen uptake, providing a basis for a wider therapeutic index

Both conjugates remained stable over 7 days (radiochemical purity above 97%), showing that CAR can be optimized for performance without compromising manufacturability or clinical supply. Safety and targeting gains can come with no manufacturing trade-off
Picture5.png
A wider therapeutic index could allow more dose to reach the tumor at a given level of safety, a proprietary radiochemistry framework Actinium is applying to de-risk its broader pipeline resulting in lower technical risk across the portfolio

(Press release, Actinium Pharmaceuticals, JUN 1, 2026, View Source [SID1234666322])

Xenetic Biosciences Showcases Compelling ASCO 2026 Data Demonstrating DNase I Significantly Enhances CAR-T Cell Persistence, Tumor Control, and Survival

On June 1, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported positive preclinical data will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating that DNase I significantly enhances CAR-T cell expansion, persistence, and antitumor efficacy in aggressive hematologic cancer models.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details:

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia (Poster Session)

Abstract Title: Targeting cfDNA and NETs with DNase I to augment CAR-T cell function and antitumor efficacy

Poster Board: 410

Presentation Date & Time: June 1, 2026, 9:00 AM – 12:00 PM CDT

Presenter: Alexey V. Stepanov, PhD

The poster presentation, titled "Targeting cfDNA and NETs with DNase I Augments CAR T-Cell Function and Antitumor Efficacy," highlights evidence that extracellular DNA and neutrophil extracellular traps (NETs) act as key drivers of CAR-T cell exhaustion and persistence, leading to therapeutic failure. The findings demonstrate that DNase I degrades these immunosuppressive barriers and restores CAR-T functionality.

In preclinical studies, DNase I efficiently degraded extracellular DNA, preserved CAR-T cell effector function, improved CD8-positive T cell ratios and reduced expression of exhaustion markers including PD-1, LAG-3 and TIM-3 across multiple rounds of tumor rechallenge in vitro.

In vivo, DNase I significantly enhanced CAR-T cell expansion and persistence following infusion in both NALM-6 B cell leukemia and Raji Burkitt lymphoma xenograft models. Combination therapy with DNase I resulted in improved tumor control, delayed relapse upon rechallenge and prolonged survival compared to CAR T-cell therapy alone.

The poster also includes translational observations from a pediatric patient with highly refractory Burkitt lymphoma, where DNase I co-administration was associated with marked CAR-T cell expansion and progressive reduction in tumor burden following prior CAR-T cell failure.

"These findings continue to strengthen the growing body of evidence implicating extracellular DNA and NETs as important contributors to immune suppression and therapeutic resistance in cancer," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic Biosciences. "We believe these data highlight the potential for DNase I to serve as a differentiated adjunctive immuno-oncology strategy capable of improving CAR T-cell persistence and durability across difficult-to-treat hematologic malignancies."

The findings further support Xenetic’s broader DNase-based immuno-oncology platform designed to improve outcomes of existing cancer therapies, including immunotherapies and cell therapies, through targeting NET-driven immune suppression within the tumor microenvironment.

(Press release, Xenetic Biosciences, JUN 1, 2026, View Source [SID1234666321])

Veracyte Announces Commercial Launch of the Prosigna Breast Test in the U.S.

On June 1, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported the U.S. commercial launch of the Prosigna Breast Risk of Recurrence (ROR) test, a genomic test for patients diagnosed with early-stage hormone-receptor positive (HR+) breast cancer. The Prosigna test determines a patient’s ROR score and estimates the 10-year probability of distant recurrence, providing prognostic insight into how a patient’s cancer may behave over time. These insights also help guide treatment decisions, including predicting whether high risk patients are likely to benefit from chemotherapy or may safely achieve optimal outcomes with endocrine therapy alone, enabling clinicians to make personalized care plans for their patients. The Prosigna test will be available to order starting June 8, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Every patient diagnosed with breast cancer deserves answers they can trust about what their cancer means and what comes next," said John Leite, PhD, chief commercial officer, Veracyte​. "Prosigna gives patients and their oncologists a deeper understanding of their individual risk of recurrence, and, for many, whether chemotherapy will truly benefit them or whether they can safely avoid it. That kind of personalized insight can bring greater confidence and reassurance as patients navigate decisions that will shape their care and future health."

In the U.S., more than 225,000 new HR+/HER2- breast cancer cases are diagnosed each year. When breast cancer is diagnosed early and treated appropriately, five-year survival rates reach 92%.1 It is critically important to accurately determine a patient’s risk of recurrence because the effects of treatment escalation or de-escalation have a lasting impact on a patient’s life.

Introducing the Prosigna Test: Prediction that adds up

The Prosigna test is the only breast cancer test that factors a patient’s biological, clinical, and pathological information into a single comprehensive analysis. The test uniquely combines intrinsic subtypes and proliferation score with clinical factors to determine a patient’s ROR score and predict the 10-year probability of distant recurrence. This long-term risk assessment provides clinically meaningful insight beyond initial diagnosis, particularly in early-stage breast cancer where recurrence can occur many years later.

For decades, clinical risk factors have been a key factor in treatment decisions. Currently, for many patients with high-risk breast cancer who are premenopausal and node positive, standard of care is still chemotherapy and endocrine therapy. New data from the OPTIMA trial shows that nodal involvement and other clinical risk factors do not automatically equate to high risk of recurrence — for the first time, more than two-thirds of node-positive patients who previously might have received chemotherapy can now safely avoid it based on the Prosigna test results.

Why the Prosigna test stands apart:

Comprehensive molecular analysis: The Prosigna test was developed from the PAM50 genomic classifier, a foundation for understanding breast cancer biology, which classifies a patient’s individual tumor into one of the four intrinsic subtypes. The Prosigna test is the only test that combines intrinsic subtypes and proliferation score with clinical pathological factors to provide a comprehensive 10-year probability of distant recurrence.
Proven across high-risk populations: The Prosigna test is the only test proven to be predictive for chemotherapy benefit decisions in a phase III prospective trial for premenopausal and postmenopausal women with high-risk breast cancer, including those with extensive nodal involvement (up to 9 positive nodes).
Superior prognostic accuracy: Extensively validated clinical evidence demonstrates that the Prosigna test is more prognostically accurate than other genomic assays, particularly in the critical 5-10 year breast cancer recurrence window.2, 3
"The PAM50 signature was designed to unlock the clinical utility of modern biological insights into the nature of breast cancer. Through the Prosigna test, these biological insights are now directly informing treatment decisions for patients," said Matthew Ellis, M.D., Ph.D., one of the developers of the PAM50-based Prosigna test. "The OPTIMA results reinforces the need to ground critical decisions upon tumor biology because understanding risk of recurrence and chemotherapy benefit as distinct principles produces safer and more personalized care."

"Patients diagnosed with early-stage breast cancer deserve access to the most advanced testing available, with the most up to date evidence, so they can make informed treatment decisions with their medical oncology team," said Jean Sachs, MSS, MLSP Chief Executive Officer of Living Beyond Breast Cancer. "Prosigna’s ability to accurately predict risk of recurrence means patients may have the option to avoid chemotherapy and its significant side effects or confidently pursue more aggressive treatment when it will truly benefit them. That is what we want for everyone diagnosed with breast cancer – a personalized treatment plan that is informed by the most up-to-date data."

Veracyte is committed to making the Prosigna test accessible to all eligible breast cancer patients. The test is currently covered by most commercial payers, and patients may qualify for financial assistance or a tailored payment plan supported by the Veracyte Access Program for eligible uninsured and underinsured patients. The Prosigna test will be available for ordering starting June 8, 2026 through Veracyte’s network nationwide via the easy-to-use Veracyte Ordering Portal. For ordering information and clinical resources, visit www.veracyte.com/prosigna.

(Press release, Veracyte, JUN 1, 2026, View Source [SID1234666320])