On June 2, 2025 ImmuneOncia Therapeutics, Inc. (CEO Heung-Tae Kim) reported interim results today from the ongoing Phase 1b clinical trial of its next-generation CD47-targeting antibody, IMC-002, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC). The data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, USA.

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The study, part of the dose-expansion phase, evaluated the safety and early efficacy of the combination therapy. IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia. Mild anemia was observed in 2 of 13 patients (15%), and 96% of adverse events were Grade 1–2, occurring primarily in the first treatment cycle.

Among 10 patients evaluable for efficacy, 3 (30%) showed a partial response (PR), while the disease control rate (DCR) reached 80%. The median progression-free survival (PFS) was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit.

AI-powered digital pathology analysis showed a 60% objective response rate (ORR) in patients with high CD47 expression on tumor cell membranes, whereas no response was observed in those with low expression – a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response.

Professor Jeong-Yong Hong of Samsung Medical Center commented, "The IMC-002 and lenvatinib combination shows strong potential as a second-line treatment option for HCC patients with limited alternatives. A 30% response rate is particularly promising, especially when compared to the approximately 10% typically observed with current second-line therapies for HCC."

CEO Heung-Tae Kim stated, "Two of the three partial responders were resistant to first-line immunotherapy, suggesting IMC-002 may offer a new path forward via macrophage-based innate immunity. We are confident that this combination could redefine second-line treatment for HCC and will enhance our patient selection strategy through AI-driven biomarker analysis."

IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPα axis to restore macrophage-mediated phagocytosis of cancer cells. It is a second-generation anti-CD47 antibody designed to minimize binding to normal cells and avoid common toxicities such as hemagglutination and cytopenia.

ImmuneOncia is currently conducting Phase 1b trial of IMC-002 in patients with solid tumors. In 2021, the company out-licensed the asset to China’s 3D Medicines in a deal worth up to $470 million. Its pipeline also includes the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202. Following its KOSDAQ listing in May 2025, ImmuneOncia aims to strengthen its global presence in immuno-oncology.

About IMC-002
IMC-002 is a novel immune checkpoint inhibitor targeting CD47, a "don’t eat me" signal expressed on cancer cells. By blocking the CD47/SIRPα interaction, IMC-002 enhances macrophage-mediated phagocytosis. It is engineered to deliver high efficacy while minimizing binding to red blood cells and avoiding hematologic toxicity.

On June 2, 2025 Bayer reported detailed results from the Phase III OASIS-4 study found that the investigational compound elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to weeks 4 and 12 compared to placebo, in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer (Press release, Bayer, JUN 2, 2025, View Source [SID1234653655]). Key secondary endpoints showed statistically significant improvement of sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo. Additional secondary endpoints showed a reduction in VMS frequency at week 1 and improvements in VMS severity at weeks 4 and 12 versus placebo. These data are being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30 – June 3 in Chicago, IL, USA, and have been simultaneously published in the New England Journal of Medicine (NEJM). OASIS-4 is the first pivotal international Phase III study to assess the safety and efficacy of elinzanetant for the treatment of moderate to severe VMS associated with endocrine therapy for the treatment or prevention of HR+ breast cancer.

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"Menopausal symptoms are frequent side effects of endocrine therapy for breast cancer, often leading to discontinuation, which is why management of these symptoms can play an important role in breast cancer treatment," said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon Portugal. "With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options."

In OASIS-4, elinzanetant showed statistically significant mean reductions in frequency of VMS compared to placebo from baseline to week 4 with −6.5 (95% confidence interval [CI], −7.2 to −5.8) with elinzanetant and −3.0 (95% CI, −3.9 to −2.2) with placebo, with statistical significance between elinzanetant and placebo (least squares [LS] mean difference [95% CI]: −3.5 [−4.4, −2.6]; p<0.001). At week 12, reductions in VMS frequency were −7.8 (95% CI, −8.5 to −7.1) with elinzanetant and −4.2 (95% CI, −5.2 to −3.2) with placebo, with statistical significance between elinzanetant and placebo (LS mean difference [95% CI]: −3.4 [−4.2, −2.5]; p<0.001). The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data1,2,3 on elinzanetant in postmenopausal women with VMS, with fatigue, somnolence and diarrhea being the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group.

The mean change in the PROMIS SD SF 8b total T score from baseline to week 12 was −10.6 points (95% CI, −11.5 to −9.6) in the elinzanetant group and −4.1 points (95% CI, −5.3 to −2.9) in the placebo (LS mean difference between the trial groups, −6.1 points; 95% CI, −7.5 to −4.8; p<0.001). The mean change in the MENQOL total score from baseline to week 12 was −1.3 points (95% CI, −1.4 to −1.2) in the elinzanetant group and −0.5 points (95% CI, −0.7 to −0.3) in the placebo group (LS mean difference between the trial groups, −0.7 points; 95% CI, −0.9 to −0.5; p<0.001). Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 with elinzanetant versus placebo.

"The results from OASIS-4 represent a potential advancement in addressing a need for women undergoing breast cancer treatment. Vasomotor symptoms associated with endocrine therapy can impact patients’ quality of life and may impact their ability to adhere to other treatments," said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. "Advancing elinzanetant as an investigational, hormone-free treatment option for these patients reaffirms our commitment at Bayer to bring forward innovative treatments for the different health needs of women."

Breast cancer is the most commonly diagnosed cancer in women globally with 2.3 million new cases in 2020, and nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer. Treatment with adjuvant endocrine therapy (such as tamoxifen) for up to 10 years substantially reduces the breast cancer mortality rate throughout the two decades after diagnosis.4 Endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. Side effects of endocrine therapy, such as VMS (also referred to as hot flashes), may affect quality of life and treatment compliance, with potential impact on recurrence.5 Currently, there are no approved treatment options available. There is an unmet medical need for an effective hormone-free treatment for VMS associated with endocrine therapy.

Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Data from OASIS-1 and -2 were published in the Journal of the American Medical Association (JAMA)3 in August 2024. Detailed results of the Phase III study OASIS-3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world.

About the Elinzanetant Clinical Development Program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of VMS due to menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized.

About Elinzanetant
Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment, such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause, which is highly relevant from both a healthcare and socio-economic perspective.

On June 1, 2025 Daiichi Sankyo reported results from three trials continue to demonstrate the potential of DATROWAY (datopotamab deruxtecan) in combination with various immunotherapies to improve outcomes in patients with non-small cell lung cancer (NSCLC) across multiple stages of the disease (Press release, Daiichi Sankyo, JUN 2, 2025, View Source [SID1234653562]). These results from TROPION-Lung02, TROPION-Lung04 and NeoCOAST-2 were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting.

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DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

"Patients with non-small cell lung cancer have limited treatment options and often experience disease progression due to the aggressive nature of the disease," said Benjamin Levy, MD, Clinical Director, Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine. "The safety and efficacy data from these trials and the exploratory QCS analysis from TROPION-Lung02 support the potential of DATROWAY to become an important medicine to use in combination with various immunotherapies to improve outcomes for patients across multiple stages of lung cancer."

"These data presented at ASCO (Free ASCO Whitepaper) continue to reinforce the potential for DATROWAY to become an important part of immunotherapy-based combination regimens for the treatment of certain patients with non-small cell lung cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We look forward to further evaluation of these combinations through our robust clinical development program in order to determine how DATROWAY may help address unmet needs of patients with lung cancer."

"The DATROWAY combination data at ASCO (Free ASCO Whitepaper), including results with our own durvalumab and rilvegostomig as well as pembrolizumab, support the combinability of this medicine and its potential to change treatment expectations across stages of lung cancer," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "Further, the results from the TROPION-Lung02 exploratory biomarker analysis offer additional evidence that the more precise measurement of TROP2, as enabled by our computational pathology platform, can help identify patients with non-small cell lung cancer more likely to respond to DATROWAY."

DATROWAY plus pembrolizumab with or without platinum-based chemotherapy show consistent tumor responses as first-line treatment of advanced NSCLC
Final results from the TROPION-Lung02 phase 1b trial of DATROWAY plus Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) with or without platinum chemotherapy in patients with advanced NSCLC without actionable genomic alterations were featured during an oral presentation (#8501) on Sunday, June 1.In 42 patients receiving first-line doublet DATROWAY plus pembrolizumab, an objective response rate (ORR) of 54.8% (95% confidence interval [CI]: 38.7-70.2) was observed. In 54 patients receiving first-line triplet DATROWAY plus pembrolizumab and platinum chemotherapy, an ORR of 55.6% (95% CI: 41.4-69.1) was observed. This analysis included patients enrolled during the dose escalation phase of the trial, where 4.8% and 40.7% of patients treated with the doublet and triplet regimens, respectively, received DATROWAY at a dose of 4 mg/kg versus 6 mg/kg. Median treatment duration was 9.7 months for patients receiving the doublet regimen and 5.8 months for those receiving the triplet regimen.

The safety profiles of the doublet and triplet regimens of DATROWAY in TROPION-Lung02 were consistent with previous analyses. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 40.5% and 55.6% of patients receiving the doublet and triplet regimens, respectively. The most common grade 3 or higher TRAEs occurring in 5% or more of patients treated with the doublet regimen were increased amylase (14%) and stomatitis (5%). The most common grade 3 or higher TRAEs occurring in 5% or more of patients treated with the triplet regimen were decreased neutrophil count (15%), neutropenia (13%), anemia (13%), increased amylase (9%), fatigue (6%) and nausea (6%). Two (4.8%) grade 3 interstitial lung disease (ILD) events in patients treated with the doublet regimen and one (1.9%) grade 3 ILD event in patients treated with the triplet regimen were adjudicated as drug-related by an independent committee.

In TROPION-Lung02, patients across six cohorts received DATROWAY plus pembrolizumab (doublet) or DATROWAY plus pembrolizumab and chemotherapy (triplet). As of data cut-off of April 29, 2024, 96 patients received either the doublet (n=42) or triplet (n=54) combination as first-line therapy.

Summary of TROPION-Lung02 First-Line Efficacy Results

Efficacy Measure

Doublet

Triplet

Overall
(n=42)

PD-L1<50%
(n=30)

PD-L1≥50%
(n=5)

Overall
(n=54)

PD-L1<50%
(n=40)

PD-L1≥50%
(n=10)

Confirmed ORR,i,ii %

(95% CI)

54.8%

(38.7–70.2)

53.3%

(34.3–71.7)

100%

(47.8–100)

55.6%

(41.4–69.1)

55%

(38.5-70.7)

60%

(26.2–87.8)

CR, %

2.4%

3.3%

0%

3.7%

2.5%

10%

PR, %

52.4%

50%

100%

51.9%

52.5%

50%

SD, %

33%

NA

NA

33%

NA

NA

PD, %

7%

NA

NA

4%

NA

NA

DCR, % (n)iii

(95% CI)

88.1% (37)

(74.4–96.0)

96.7% (29)

(82.8–99.9)

100% (5)

(47.8–100)

88.9% (48)

(77.4–95.8)

87.5% (35)

(73.2–95.8)

90% (9)

(55.5–99.7)

Median DoR,

(months) (95% CI)

20.1 months

(9.7–NE)

12 months

(8.0–NE)

NE

(5.5–NE)

13.7 months

(5.7–NE)

14.6 months

(5.3–NE)

NE

(4.1–NE)

Median PFS, (months) (95% CI)

11.2 months

(8.2–21.3)

11.1 months

(7.2–13.3)

NE

(8.3–NE)

6.8 months

(5.5–11.1)

6.4 months

(5.5–13.2)

6.8 months

(0.8–NE)

CI, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; NA, not available; NE, not estimable; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease

iORR is CR+ PR

iiAs assessed by investigator

iiiProportion of patients with confirmed CR + confirmed PR + SD.

Tissue samples collected from patients in TROPION-Lung02 were analyzed retrospectively using quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational platform. Tumors were considered biomarker positive if ≥75% of tumor cells exhibited a normalized membrane ratio (NMR) below a predetermined value (≤0.56), indicating a greater proportion of TROP2 in the cytoplasm than on the membrane. Results from this exploratory analysis showed that TROP2-NMR biomarker positivity was associated with a trend toward prolonged progression free survival (PFS) in patients treated with the doublet (hazard ratio [HR]: 0.50; 95% CI: 0.19-1.29) and triplet (HR: 0.67; 95% CI: 0.33-1.36) regimens, and a trend toward prolonged overall survival in patients treated with the doublet (HR: 0.35; 95% CI: 0.07-1.72) and triplet (HR: 0.71; 95% CI: 0.31-1.59) regimens compared to the TROP2-NMR biomarker negative population.

DATROWAY plus rilvegostomig show encouraging activity in first-line treatment of advanced NSCLC
First results from cohort 5 of the TROPION-Lung04 phase 1b trial, presented during a poster session (#8521) on Saturday, May 31, showed DATROWAY plus AstraZeneca’s PD-1/TIGIT bispecific antibody rilvegostomig as a first-line treatment demonstrated an ORR of 57.5% (95% CI: 40.9-73.0), including one complete response (CR) and 22 partial responses (PRs) in 40 patients with advanced or metastatic NSCLC. A disease control rate (DCR) of 95% (95% CI: 83.1-99.4) was seen. Objective responses were observed across both squamous (45.5%; 95% CI: 16.7-76.6) and nonsquamous (62.1%; 95% CI: 42.3-79.3) histologies and all PD-L1 expression levels. Median duration of response (DoR) was 5.8 months (4.5-not evaluable [NE]).

The safety profile of DATROWAY and rilvegostomig was consistent with the known safety profile of each agent with no new safety signals identified. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 60% of patients. The most common grade 3 or greater TEAEs were pneumonia (10%), pneumonitis (7.5%), anemia (2.5%), decreased appetite (2.5%), increased amylase (2.5%), musculoskeletal pain (2.5%), rash (2.5%) and stomatitis (2.5%). Three (7.5%) grade 2 ILD events and two (5%) grade 3 ILD events were adjudicated as drug-related by an independent committee.

Cohort 5 of TROPION-Lung04 enrolled patients with untreated advanced NSCLC without actionable genomic alterations. As of data cut-off of October 24, 2024, 40 patients received DATROWAY plus rilvegostomig with a median treatment duration of 5.1 months. DATROWAY treatment was ongoing in 19 patients and rilvegostomig treatment was ongoing in 20 patients.

Daiichi Sankyo and AstraZeneca are evaluating DATROWAY plus rilvegostomig as first-line treatment for patients with advanced or metastatic nonsquamous NSCLC with PD-L1 ≥50% and without actionable genomic alterations in the TROPION-Lung10 phase 3 trial.

DATROWAY plus durvalumab and chemotherapy demonstrate encouraging pathological response rates in patients with early-stage resectable NSCLC
Final results from Arm 4 of the NeoCOAST-2 phase 2 platform trial evaluating neoadjuvant DATROWAY plus AstraZeneca’s anti-PD-L1 therapy IMFINZI (durvalumab) and single-agent platinum chemotherapy were presented during a poster session (#8046) on Saturday, May 31 and showed the combination demonstrated a pathologic complete response (pCR) rate of 35.2% (95% CI: 22.7-49.4) and a major pathologic response (mPR) rate of 63% (95% CI: 48.7-75.7). This was numerically higher than response rates shown by other combination regimens evaluated in Arm 1 and Arm 2 of NeoCOAST-2; however, the trial was not powered to make direct statistical comparisons between arms. These results, along with results from these other two arms of NeoCOAST-2, were simultaneously published in Nature Medicine.

The safety profile of DATROWAY, durvalumab and single-agent platinum chemotherapy was consistent with the known safety profile of each agent with no new safety signals identified. Feasibility of surgery was maintained with this arm of NeoCOAST-2 relative to the standard of care. Grade 3 or higher TEAEs occurred in 24.1% of patients in the neoadjuvant period.

About TROPION-Lung02
TROPION-Lung02 is an ongoing global, open-label, six-cohort phase 1b trial evaluating the safety and efficacy of DATROWAY at two dose levels (4 mg/kg and 6 mg/kg) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab; 200 mg) with or without four cycles of platinum chemotherapy (carboplatin or cisplatin) in patients with previously untreated or pretreated locally advanced or metastatic NSCLC without actionable genomic alterations (e.g., EGFR, ALK, ROS1, NTRK, BRAF, RET, MET or other known AGAs). Participants with tumors that harbor KRAS mutations are eligible for this study.

The primary endpoints of TROPION-Lung02 are dose-limiting toxicities and treatment-emergent adverse events. Secondary endpoints include ORR, DoR, PFS as assessed by investigator, overall survival, pharmacokinetics and anti-drug antibodies for DATROWAY and pembrolizumab.

TROPION-Lung02 is one of three clinical trials along with the phase 3 TROPION-Lung07 and TROPION-Lung08 trials in a collaboration and supply agreement between Daiichi Sankyo, AstraZeneca and Merck (known as MSD outside of the United States and Canada) to evaluate the combination of DATROWAY and pembrolizumab.

TROPION-Lung02 enrolled 145 patients in Asia, Europe and North America. For more information visit ClinicalTrials.gov.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TROPION-Lung04
TROPION-Lung04 is an ongoing global, open-label, 15-cohort phase 1b trial evaluating the safety and efficacy of DATROWAY (4 mg/kg or 6 mg/kg) in combination with immunotherapy (durvalumab, rilvegostomig or volrustomig) with or without up to four cycles of carboplatin in patients with advanced or metastatic NSCLC without actionable genomic alterations. Participants with tumors that harbor KRAS mutations are eligible for this study. Patients enrolled in the cohorts evaluating durvalumab were previously untreated or had received one or fewer lines of systemic chemotherapy without concomitant immunotherapy.

The primary endpoints of TROPION-Lung04 are safety and tolerability. Secondary endpoints include ORR, DCR, duration of response and progression-free survival as assessed by investigator.

Rilvegostomig is AstraZeneca’s PD-1/TIGIT bispecific antibody. The TIGIT component of rilvegostomig is derived from the clinical-stage anti-TIGIT antibody, COM902, developed by Compugen Ltd. (Nasdaq/TASE: CGEN).

TROPION-Lung04 will enroll more than 370 patients in Asia, Europe and North America. For more information visit ClinicalTrials.gov.

About NeoCOAST-2
NeoCOAST-2 is a global, randomized, multicenter, open-label, multi-arm phase 2 platform trial conducted by AstraZeneca evaluating the efficacy and safety of durvalumab in multiple novel combinations, before and after surgery, in patients with resectable, early-stage (stage IIA-IIIB) NSCLC.

The dual primary endpoints of NeoCOAST-2 are antitumor activity of neoadjuvant treatment assessed by pCR and the safety and tolerability of neoadjuvant and adjuvant treatment. Secondary endpoints include event-free survival, disease-free survival and ORR as determined by investigator using RECIST version 1.1, OS, feasibility of surgery, and mPR determined by central blinded independent pathologist review.

NeoCOAST-2 will enroll approximately 630 patients in Asia, Europe and North America. For more information visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer
Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.1 NSCLC is the most common type of lung cancer, accounting for about 87% of cases.2 While most NSCLC cases are diagnosed in the advanced setting, between 25 to 30% of diagnoses occur in the early stage of the disease.3,4

Despite improvements in treatment for early-stage NSCLC, patients may experience disease recurrence even after complete tumor resection with or without treatment with adjuvant therapy.5,6,7 For patients with advanced NSCLC without actionable genomic alterations, immunotherapy with or without platinum-based chemotherapy is the standard first-line treatment. While these medicines have improved outcomes in the first-line metastatic setting, most patients experience disease progression.8,9,10

TROP2 is a protein broadly expressed in the majority of NSCLC tumors.11 There is currently no TROP2 directed ADC approved in the U.S. for the treatment of lung cancer.

About DATROWAY
DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

About the DATROWAY Clinical Development Program
A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings.

On June 2, 2025 Ichnos Glenmark Innovation (IGI), a global, fully integrated clinical-stage biotechnology company focused on developing multispecificsTM in oncology, reported promising full dose-escalation results from its Phase 1 TRIgnite-1 study of ISB 2001, an investigational first-in-class BCMA × CD38 × CD3-targeting trispecific antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) (Press release, Ichnos Sciences, JUN 2, 2025, View Source;utm_medium=rss&utm_campaign=igi-asco-isb2001-high-orr-favorable-safety-data [SID1234653608]). These data, presented as a rapid oral presentation (Abstract #7514) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, demonstrated a sustained overall response rate (ORR) of 79% and a high complete/stringent complete response (CR/sCR) rate of 30% across seven active dose levels (≥ 50 µg/kg) in a heavily pretreated patient population, with a favorable safety profile. The ORR was 74% in all treated patients, including two patients treated at lower dose levels.

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ISB 2001 was designed to simultaneously target multiple myeloma by binding to the tumor-associated antigens BCMA and CD38, even when expressed at low levels, while engaging T cells to trigger an immune response. This novel trispecific design enhances tumor-specific cytotoxicity and aims to overcome resistance mechanisms seen with first-generation bispecific antibodies and CAR T-cell therapies, while minimizing off-tumor toxicity.

Professor Hang Quach, M.D., Professor of Haematology at the University of Melbourne and Director of Haematology at St. Vincent’s Hospital Melbourne, said "Responses to ISB 2001 highlight the remarkable anti-myeloma activity of this first-in-class anti-BCMA × CD38 × CD3 trispecific antibody-T cell engager in heavily pretreated RRMM patients, including those who have exhausted prior T cell-redirecting, BCMA-targeted, or anti-CD38 therapies – an especially challenging, quad-exposed patient population. With its unprecedented potency and tolerability, ISB 2001 has the potential to redefine the treatment landscape for RRMM, offering new hope for patients with limited therapeutic options."

A total of 35 patients with at least one month of follow-up had received a median of six prior lines of therapy (range: 3–11) at study entry, underscoring a heavily pretreated population. ISB 2001 demonstrated high response rates at active dose levels, with 33 patients treated at ≥ 50 µg/kg (dose levels 3–9). Responses were durable and deepened over time, irrespective of prior lines of therapy or refractoriness status, reinforcing the strength of earlier findings reported at ASH (Free ASH Whitepaper) 2024 Annual Meeting in 18 patients treated with ISB 2001 at doses ≥ 50 µg/kg:

The ORR was 79% (26/33), including a CR/sCR rate of 30% (10/33), with a median follow-up of 6.3 months (range: 1–16).
Of the 10 patients achieving CR/sCR, eight were evaluable for minimal residual disease (MRD), and six achieved MRD negativity, indicating no detection of myeloma cells by molecular or flow cytometry assays with 10-5 sensitivity, and reinforcing the depth of response.
Among 25 patients refractory to anti-CD38 therapies, the ORR was 72%, with a CR/sCR rate of 24%.
In 19 patients without prior T-cell directed therapy (TCDT), including bispecific antibodies and/or CAR T-cell therapy, the ORR was 84%, with CR/sCR rate of 32%.
Among 14 patients previously treated with TCDT, the ORR remained strong at 71% with a CR/sCR rate of 28%.
In 15 patients who had received prior BCMA-targeted therapies, the ORR was 73%, with a CR/sCR rate of 27%.
The median half-life of ISB 2001 was approximately 17 days, supporting the potential for less-frequent dosing.
ISB 2001 demonstrated a favorable safety profile throughout the dose-escalation phase, with no dose-limiting toxicities (DLTs) reported. Cytokine release syndrome (CRS) occurred in 24 patients (69%), primarily Grade 1, with only four patients experiencing Grade 2 events. CRS was mostly limited to the first administration of ISB 2001, and no severe or life-threatening cases were observed. Drug-related severe infections were infrequent (4 patients, 11%), with no Grade 4 or higher infection. One patient experienced Grade 1 ICANS; no other drug-related neurologic adverse events were reported.

The dose-expansion portion of the Phase 1 study is ongoing to establish the recommended Phase 2 dose (RP2D) and the best dosing schedule to enable the first registrational study with ISB 2001.

"The high response rates and low safety concerns demonstrated in the dose-escalation portion of the TRIgnite-1 study, conducted in a heavily pretreated population across multiple types of therapies, reinforce the promise of ISB 2001 as a potential new treatment for patients," said Lida Pacaud, M.D., Chief Medical Officer at IGI. "As we advance to the second part of the TRIgnite-1 study, our focus is now on defining the recommended dosing schedule and evaluating ISB 2001 in a larger population of heavily pretreated RRMM patients, where we hope to observe similarly impressive treatment responses and tolerability."

About TRIgnite-1

TRIgnite-1 (NCT05862012) is an ongoing Phase 1, first-in-human, open-label, multicenter study evaluating the safety and anti-myeloma activity of ISB 2001 in patients with RRMM. The dose-escalation study enrolled patients with RRMM who were treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies and are refractory to, or intolerant of, established therapies known to provide clinical benefit in multiple myeloma. Patients with prior CAR-T cell therapies, bispecifics and/or prior BCMA targeted agents were eligible.

The TRIgnite-1 study has two parts: dose escalation and dose expansion. The dataset presented comes from patients treated in the entire dose-escalation portion who have at least 1-month follow-up at six sites in the United States and Australia. The dose-expansion study is randomized, compliant with Project Optimus at the U.S. Food and Drug Administration (FDA), and is underway in the U.S. and Australia, with European enrollment beginning soon.

About ISB 2001 and Relapsed/Refractory Multiple Myeloma

ISB 2001 is a first-in-class trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells. Developed using IGI’s proprietary BEAT protein platform, ISB 2001 was engineered with two distinct binders against myeloma-associated antigens to enhance avidity, even at low target expression levels, while aiming to improve safety over first-generation bispecific antibodies.

The U.S. Food and Drug Administration (FDA) granted ISB 2001 Fast Track Designation in May 2025 and Orphan Drug Designation in July 2023.

Nearly all patients with RRMM ultimately experience disease progression. With no cure currently available and limited treatment options once approved therapies are exhausted, there remains a significant unmet need. IGI is developing ISB 2001 to address this gap, specifically for patients who have previously received T-cell–directed therapies, including CAR T-cell treatments and bispecific antibodies.

On June 2, 2025 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the Jefferies Global Healthcare Conference, being held at the Marriott Marquis, in New York City on June 3-5, 2025 (Press release, TG Therapeutics, JUN 2, 2025, View Source [SID1234653624]). The fireside chat is scheduled to take place on Wednesday, June 4, 2025, at 12:50 PM ET.

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source