On May 22, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported the preliminary PoC clinical study results for its global first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. An overview of the abstract information is provided below, and the full abstract is available here. More detailed results will be presented during the conference.

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This study is the first stage of a PoC clinical study conducted in China, to evaluate the safety, efficacy, and dose optimization strategy of IBI363 in combination with platinum-based doublet chemotherapy (PDC) in previously untreated patients with locally advanced or metastatic NSCLC. During dose optimization, patients with NSCLC expressing PD-L1 TPS < 50% (including TPS 1-49% and TPS < 1%) were enrolled to explore the potential of IBI363 in PD-L1 negative and low-expressing NSCLC, an area with significant unmet clinical need.

The preliminary results showed that IBI363 combined with PDC demonstrated encouraging efficacy signals in the first-line treatment of NSCLC with PD-L1 negative or low expression. The 3→1.5 mg/kg dosing regimen brought comprehensive benefits with strong objective response rate (ORR), disease control rate (DCR), and manageable safety and tolerability. Meanwhile, the approach supports continuous dosing, which has the potential to translate into durable efficacy benefits with ongoing follow-up. The second stage of this study is currently ongoing, designed as a randomized head-to-head trial comparing this dose regimen vs. pembrolizumab plus chemotherapy in the first-line treatment of advanced NSCLC (all PD-L1 expression levels).

1) Mechanistic Rationale for Dosing Regimen Design and Dose Selection in Immunotherapy-naïve Population

Multiple studies have indicated that in immunotherapy (IO)-naive populations, the tumor microenvironment exhibits lower immunosuppression, which allows an immune activation strategy that ignites immunity and then maintains stability. Meanwhile, combination with chemotherapy can facilitate antigen release and activate the immune system.

Therefore, the first cycle of 3 mg/kg IBI363 could initiate the immune system to expand effector T cells rapidly, enhance T cell infiltration, and form an IO-sensitive immune microenvironment. Subsequently, a 1.5 mg/kg every three weeks (Q3W) regimen is adopted for the maintenance treatment, which could maintain the IO-sensitive tumor microenvironment, prolong the possible treatment cycles, and further enhance the efficacy. This strategy is common in the study design of other immunological treatments.

Based on this mechanism, three IBI363 combination dosing regimens were compared in the study:

3→1.5 mg/kg dose group (3 mg/kg + PDC in cycle 1, followed by 1.5 mg/kg Q3W + PDC);
1.5 mg/kg dose group (1.5 mg/kg Q3W + PDC);
3 mg/kg dose group (3 mg/kg Q3W + PDC).
2) Study Design and Baseline Characteristics: Focusing on Dose Exploration in PD-L1 Negative or Low Expression NSCLC

Previously untreated patients with locally advanced or metastatic NSCLC, without sensitizing EGFR, ALK, or ROS1 alterations were enrolled in this study. The aim of the study is to evaluate the efficacy and safety of different doses of IBI363 combined with PDC in patients with PD-L1 negative or low expression NSCLC.

As of the data cutoff date, Dec 22, 2025, a total of 80 patients had been enrolled in this Phase 1 study, including 11 patients enrolled in the safety lead-in phase and 69 patients in the dose optimization phase. The median follow-up time was 5.8 months (range: 0.9–9.5 months).

The median age was 64 years, 88.8% were male, 81.3% had an ECOG PS score of 1, and 66.3% were squamous NSCLC. The baseline characteristics of patients in the three dose groups were balanced and comparable.
In the dose optimization part, NSCLC patients with PD-L1 TPS < 50% were enrolled, of which 65.2% had PD-L1 TPS < 1% and 34.8% had TPS 1–49%.
3) IBI363 Showed Encouraging Response in First-line Treatment of PD-L1 Negative or Low Expression NSCLC

In the dose optimization stage, the 3→1.5 mg/kg dose group (n=22) showed ORR of 86.4% and confirmed ORR (cORR) of 81.8% (95% CI: 59.7-94.8) and DCR of 100%. The efficacy was consistent in the squamous (ORR 85.7%, n=14) and non-squamous (ORR 87.5%, n=8) subgroups. Additionally, durable efficacy signals were observed in the 3→1.5 mg/kg groups with ongoing follow-up. For the 1.5mg/kg (N = 19) and 3 mg/kg cohorts (N = 21), ORR was 57.9% (cORR: 42.1%) and 66.7% (cORR: 57.1%), respectively.

For NSCLC patients with negative or low PD‑L1 expression, the benefit from current immunotherapies is limited. In the Keynote‑407 study, in first‑line squamous NSCLC patients treated with PD‑1 combined with chemotherapy, the ORRs were 54.5% and 67.4% for the PD‑L1 1–49% and PD‑L1 <1% subgroups, respectively. In the Keynote‑189 study, in first‑line non‑squamous NSCLC patients treated with PD‑1 combined with chemotherapy, the ORRs were 50.0% and 33.1% for the PD‑L1 1–49% and PD‑L1 <1% subgroups, respectively.

Previous studies have shown that, regardless of PD‑L1 expression status, IBI363 demonstrates potent anti‑tumor activity in immunotherapy‑resistant NSCLC, suggesting that its unique mechanism of action may not depend on PD‑L1 expression. Preliminary efficacy data in this study showed impressive response rate of IBI363 in combination with PDC in first-line treatment of NSCLC with PD-L1 negative or low expression. This further validates IBI363 as a PD-1/IL-2α-bias bispecific fusion protein capable of exerting potent anti-tumor effects regardless of PD-L1 expression status, underscoring the powerful immune-activating effects of IL-2.

4) Favorable Safety Supports Continuous Administration with Potential to Translate into Long-term Efficacy Benefits

Good safety and tolerability were observed in 3→1.5 mg/kg dose groups. Among all patients, grade ≥3 treatment-related adverse events (G3+ TEAEs) were occurred in 65.2% of patients in the 3→1.5 mg/kg dose group, which was lower than the 3 mg/kg dose group (93.1%) and the 1.5 mg/kg dose group (82.1%). This favorable safety supports 3→1.5 mg/kg as the recommended dose regimen for further clinical investigation of IBI363 in combination therapies as a first-line treatment of NSCLC, which has the potential to translate into durable efficacy benefits.

The most common treatment emergent adverse events (TEAEs) among all patients were anemia (any grade: 78.8%; grade ≥3: 18.8%), neutrophil count decrease (75.0%; 42.5%), white blood cell count decrease (63.8%; 20.0%), arthralgia (51.3%; 2.5%), and platelet count decrease (45.0%; 17.5%).

5) Conclusion and follow-up:

Based on the comprehensive evaluation of preliminary efficacy and safety data, dose regimen of 3→1.5 mg/kg is the recommended dose for further clinical investigation of IBI363 combined with chemotherapy as a first-line treatment for advanced NSCLC. Currently, as the second part of the PoC study, a randomized head-to-head study of 3→1.5 mg/kg IBI363 combined with chemotherapy vs. pembrolizumab combined with chemotherapy as first-line treatment for advanced NSCLC (all PD-L1 expression levels) is ongoing.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "IBI363 is designed to break through the bottleneck of current immunotherapy. Data from this study demonstrate that by designing a dosing strategy consistent with its immune mechanism, IBI363 achieved an encouraging response rate, leveraging its strong advantages in effectively activating the IL-2 pathway in first-line NSCLC patients with PD-L1 negative or low expression. At the same time, its favorable safety and tolerability holds the potential to translate into long term efficacy benefits. This not only further validates the mechanism but also represents a significant step in its clinical application. We look forward to continued evaluation of IBI363 in first-line treatment of NSCLC and the accumulation of data from the ongoing head-to-head PoC study to provide further evidence for the development of IBI363."

About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm blocks PD-1 and selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

(Press release, Innovent Biologics, MAY 22, 2026, View Source;innovent-announces-preliminary-poc-data-of-ibi363-pd-1il-2-bias-bispecific-fusion-protein-in-combination-with-chemotherapy-as-first-line-treatment-for-advanced-nsclc-showing-encouraging-efficac-302779649.html [SID1234666020])

On May 22, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy (sacituzumab govitecan-hziy) as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy. The European Commission decision on the additional Trodelvy indication is anticipated later in 2026.

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Metastatic TNBC is an aggressive form of breast cancer that is associated with low survival rates. For many patients with metastatic TNBC, first-line therapy may be their only line of treatment, necessitating an urgency to act using the most effective treatment options first to maximize patient outcomes.

"Metastatic TNBC remains one of the most challenging breast cancer subtypes to treat, particularly at the time of first diagnosis of advanced disease, when therapeutic options are limited for many patients," said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. "The CHMP’s positive opinion for sacituzumab govitecan represents an important step towards potential approval in this setting and reflects the clinically meaningful results observed in the ASCENT-03 study. Advancing effective treatment options earlier in the disease course is critical to improving outcomes for people living with metastatic TNBC."

The CHMP’s recommendation is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. Gilead has also submitted an application to the U.S. Food and Drug Administration for approval of Trodelvy in this indication based on the ASCENT-03 study.

"This CHMP positive opinion for Trodelvy represents a pivotal moment for people with metastatic TNBC across Europe, and we look forward to hearing from the European Medicines Agency," said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. "Building on the extensive clinical experience with Trodelvy in later lines of therapy, this recommendation has the potential to fundamentally change how we approach treating certain first-line metastatic TNBC patients, offering a much-needed option earlier in care when it can make the greatest difference. Each step forward means more options and more chances to change the story for people living this cancer."

Gilead has also submitted supplemental filings to the European Medicines Agency and the U.S. Food and Drug Administration for Trodelvy in combination with Keytruda (pembrolizumab) for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. These applications are currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L mTNBC, across PD-L1 status.

Trodelvy is currently approved as a second-line plus treatment for metastatic TNBC and for patients with pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer. Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated across 60+ countries since 2020. It remains the only Trop-2-directed ADC to demonstrate meaningful overall survival benefits in both second-line or later metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer. It is also the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer (mBC).

The use of Trodelvy plus pembrolizumab in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

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

About Triple-Negative Breast Cancer

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

U.S. INDICATIONS FOR TRODELVY

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY

BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, MAY 22, 2026, View Source [SID1234666005])

On May 22, 2026 Inocras, a bioinformatics-led company harnessing the power of whole-genome data and proprietary analytics to deliver curated insights, reported that new real-world evidence evaluating whole-genome sequencing-based homologous recombination deficiency phenotyping has been accepted for online publication at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The abstract, titled "Whole-genome HRD phenotyping as a predictor of PARP inhibitor benefit in first-line maintenance high-grade serous ovarian cancer," reports findings from a collaborative study between Inocras and the Severance Hospital gynecologic oncology team, one of Inocras’s major clinical partners in Korea.

Using matched tumor-normal whole-genome sequencing through CancerVision, investigators evaluated 84 patients with high-grade serous ovarian cancer who received PARP inhibitor maintenance therapy in either the first-line or second-line maintenance setting. The study assessed whether WGS-based HRD indicators, or CancerVision’s WGS-HRD, correlated with clinical outcomes following PARP inhibitor therapy.

Patients classified as WGS-HRD-positive had a longer median progression-free survival than those classified as WGS-HRD-negative, with an overall mPFS of 27.5 months versus 12.0 months. The association was most pronounced in the first-line maintenance setting, where WGS-HRD positive patients had an mPFS of 44.2 months versus 10.0 months. In the second-line maintenance setting, no significant difference in survival was observed based on HRD status, suggesting the predictive value of WGS-HRD may be strongest in earlier treatment settings.

The study also found that 21.4% of patients were WGS-HRD positive despite lacking BRCA mutations, underscoring the potential of WGS-HRD to identify patients who may not be captured by BRCA testing alone. Compared with the conventional scarHRD method, WGS-HRD demonstrated higher predictive value in clinical prognosis and PARP inhibitor responsiveness. The study adds to Inocras’ growing body of evidence supporting CancerVision as a comprehensive whole-genome sequencing platform for precision oncology.

"These findings provide important real-world evidence that whole-genome HRD scoring can advance how we identify ovarian cancer patients most likely to benefit from PARP inhibitor maintenance therapy," said Jehee Suh, CEO of Inocras. "CancerVision is a comprehensive WGS-based clinical analysis platform, and these data highlight its potential to enhance clinical decision-making."

"The first-line maintenance findings are particularly encouraging because they suggest that WGS-based HRD assessment may refine current BRCA- and genomic-scar–based approaches for identifying patients most likely to derive durable benefit from PARP inhibitor maintenance therapy," said Joonoh Lim, Physician Scientist at Inocras, who led the study in collaboration with Severance Hospital. "These findings add to the growing evidence base for whole-genome HRD assessment, and we look forward to prospective validation."

Abstract Details

Title: Whole-genome HRD phenotyping as a predictor of PARP inhibitor benefit in first-line maintenance high-grade serous ovarian cancer.
Format: Online publication / Online-only abstract
Abstract Number: e17608
Publication Date/Time: May 21 at 05:00 PM ET
Authors: Joonoh Lim, MD, PhD, Inocras Inc., San Diego, CA
Session/Category: Gynecologic Cancer

(Press release, Inocras, MAY 22, 2026, View Source [SID1234666021])

On May 22, 2026 Formosa Pharmaceuticals, Inc. reported that its abstract highlighting the differentiated binding profile and preclinical efficacy of TSY-310, a novel bispecific antibody-drug conjugate (ADC), has been selected for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago, Illinois. TSY-310 simultaneously targets EGFR and ROR1, two receptors frequently co-expressed in prevalent solid tumors. By leveraging a unique bispecific modality, TSY-310 optimizes target engagement and intracellular delivery, facilitating a potent bystander effect to address the challenges of tumor heterogeneity.

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Details

Title: TSY-310, A Novel Bispecific EGFR x ROR1 ADC, Exhibits Potent Antitumor Activity in Heterogeneous Breast Tumors Through Enhanced Internalization and Bystander Cytotoxicity
Session: Developmental Therapeutics: Molecularly Targeted Agents and Tumor Biology
Date & Time: May 30, 2026, 1:30 pm – 4:30 pm CT
Abstract Number: 3086
Poster Number: 223
Presenter: Dr. Kuo-Ming Yu, Ph.D., Director, CMC and Production

Highlights

Superior Selectivity: Bispecific binding, enhancing internalization specifically in tumor cells co-expressing EGFR and ROR1.
Enhanced Payload Delivery: Evidence of efficient lysosomal trafficking and the subsequent release of the cytotoxic payload.
Bystander Efficacy: Eradication of neighboring antigen-negative tumor cells, a critical factor in treating complex, heterogeneous tumor environments.

"Our participation at ASCO (Free ASCO Whitepaper) is an acknowledgement of the program’s potential as a worthy contributor to the future oncology treatment landscape," said Erick Co, President & CEO of Formosa Pharmaceuticals. "We are eager to place TSY-310 in the toolbox of oncologists and patients who face the evolving challenges with traditional single-target therapies."

Full abstract and presentation details will be available through ASCO (Free ASCO Whitepaper) and corporate websites in accordance with the meeting’s policies.

About TSY-310: TSY-310 is a next-generation bispecific ADC targeting EGFR and ROR1. By achieving high-affinity target recognition through an efficient, simplified protein architecture, TSY-310 aims to provide a durable, "best-in-class" therapeutic option for patients with advanced solid tumors, including Non-Small Cell Lung Cancer (NSCLC).

(Press release, Formosa Pharmaceuticals, MAY 22, 2026, View Source [SID1234665926])

On May 22, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) today comments on a recent update shared by Shanghai Henlius Biotech, Inc. regarding long-term follow-up observations from clinical studies of HLX22.

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According to Henlius’ communication, long-term follow-up over more than 39 months indicates that patients treated with HLX22 continue to demonstrate extended progression-free survival (PFS) at the current observation point. The update reflects ongoing follow-up and does not include new numerical efficacy data.

HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"We view Henlius’ update on the long-term follow-up of HLX22 as further evidence of the continued clinical development of the program," said Søren Bregenholt, CEO of Alligator Bioscience. "Sustained follow-up across studies is an important part of building the overall understanding of a molecule’s profile, and we note Henlius’ ongoing efforts to advance HLX22 across multiple indications."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, MAY 22, 2026, View Source [SID1234666006])