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Zai Lab and Novocure Announce Results From the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer to be Presented at 2025 ASCO Annual Meeting

On June 1, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) reported that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer will be presented today at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology (Press release, Zai Laboratory, JUN 1, 2025, View Source [SID1234653574]).

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"The data presented today from the PANOVA-3 trial of Tumor Treating Fields show a clinically meaningful and statistically significant improvement in overall survival for people with locally advanced pancreatic cancer," said Vincent Picozzi, MD, MMM, medical oncologist and investigator in the PANOVA-3 trial. "Importantly, we also saw an extension in the duration of time before pain progressed. Pain is a hallmark of this disease, and as a clinician, the potential of this therapy to address this aspect of pancreatic cancer is very encouraging. These results illustrate the potential of Tumor Treating Fields therapy concomitant with gemcitabine and nab-paclitaxel to become a standard of care for unresectable, locally advanced pancreatic cancer."

The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields.

"The encouraging data from the Phase 3 PANOVA-3 study demonstrate a meaningful improvement in outcomes for patients with unresectable, locally advanced pancreatic cancer—including pain reduction and a statistically significant improvement in overall survival," said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. Zai Lab participated in this trial and looks forward to continuing our collaboration with Novocure to bring this innovative therapy to patients in China as quickly as possible."

"Most people with pancreatic cancer are diagnosed with advanced disease, which is very difficult to treat and only about 1 in 10 people are alive five years after diagnosis," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "The results shared today at ASCO (Free ASCO Whitepaper) and in the Journal of Clinical Oncology demonstrate that Tumor Treating Fields therapy improved overall survival and pain-free survival in unresectable, locally advanced pancreatic cancer. We plan to submit these data to the FDA in the second half of 2025 to support a premarket approval for Tumor Treating Fields therapy."

Results from PANOVA-3

In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement [hazard ratio (HR) 0.82; p=0.039 (N=571)].

TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate and pain-free survival. Pancreatic cancer can cause significant pain as the disease progresses and managing pain is a key clinical challenge.

The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group with 68.1% [95% CI: 62.0–73.5] compared to those who received gemcitabine and nab-paclitaxel alone, 60.2% [95% CI: 54.2–65.7], p=0.029.
Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months [95% CI: 10.3–22.8] compared to a median 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone [95% CI: 7.4–12.7]; HR 0.74 [95% CI: 0.56–0.97], p=0.027. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual scale for pain or until death.
Quality of life was also measured as a secondary endpoint. Analyses were performed for all patients using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum. Deterioration-free survival in global health status, pain and digestive problems were significantly improved in patients receiving TTFields therapy concomitant with gemcitabine and nab-paclitaxel compared to the gemcitabine and nab-paclitaxel alone group. Full analysis of the quality of life results in PANOVA-3 will be shared at a future scientific conference.

There was no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms.

TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.

Data Presentation & Publication Details

The PANOVA-3 data, (LBA 3500) Phase 3 study of Tumor Treating Fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC), will be presented today by Dr. Picozzi in Hall D1 during the 3:00 – 6:00 p.m. Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary oral session.

The Phase 3 PANOVA-3 publication in the Journal of Clinical Oncology, Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase 3 PANOVA-3 study, will be available online at View Source

Protagonist and Takeda Announce ASCO Plenary Presentation Highlighting Full 32-Week Results from Phase 3 VERIFY Study of Rusfertide, Showing Reductions in Phlebotomy, Improved Hematocrit Control in Polycythemia Vera

On June 1, 2025 Protagonist Therapeutics, Inc. ("Protagonist") (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) reported detailed results from the Phase 3, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints (Press release, Takeda, JUN 1, 2025, View Source [SID1234653573]). The data will be presented as a late-breaking oral presentation at the 61st American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting Plenary Session (LBA3) at 2:09 pm CDT today.

PV is characterized by overproduction of red blood cells (erythrocytosis), which may increase blood viscosity, or thickness, potentially resulting in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. People with PV can experience burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus, which may negatively impact their daily functioning and quality of life. Hematocrit is the ratio of red blood cells to total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate symptoms, but many patients still experience uncontrolled hematocrit levels with current standard of care treatments.

Rusfertide, an investigational, first-in-class hepcidin mimetic peptide therapeutic, is under evaluation in the Phase 3 VERIFY study for its potential to regulate iron homeostasis and red blood cell production to control hematocrit levels in patients with PV. In the study, patients dependent on frequent phlebotomy, with or without treatment with cytoreductive therapy, were randomized to receive once-weekly rusfertide or placebo, as an add-on to current standard of care treatment.

"PV poses significant challenges for patients, including debilitating symptoms and the risk of serious thrombotic events, and hematocrit control is crucial to improving patient outcomes. The VERIFY study demonstrated that treatment with rusfertide controls hematocrit levels in phlebotomy-dependent patients, including patients receiving cytoreductive therapies," said Dr. Andrew T. Kuykendall, M.D., VERIFY Lead Investigator and Associate Member in the Department of Hematology at Moffitt Cancer Center. "These results suggest rusfertide has the potential to become part of the standard of care treatment for patients with PV."

The study met its primary endpoint, which was the proportion of patients achieving a clinical response, defined as the absence of phlebotomy eligibility during study Weeks 20-32. Study results demonstrated 76.9% of patients treated with rusfertide plus current standard of care achieved a clinical response, compared to 32.9% in the placebo plus current standard of care group (p<0.0001).1 The response observed in the rusfertide arm was consistent across subgroups, regardless of risk status or type of concurrent cytoreductive therapy.1 In addition, all key secondary endpoints met statistical significance in favor of the rusfertide arm compared to the placebo arm in the VERIFY study, as follows:

The mean number of phlebotomies was 0.5 phlebotomies per patient for those treated with rusfertide plus current standard of care compared to 1.8 phlebotomies per patient for those treated with placebo plus current standard of care during Weeks 0-32 (p<0.0001).1
Only 27% of patients treated with rusfertide plus current standard of care required phlebotomy between Weeks 0-32, compared to 78% of patients who received placebo plus current standard of care.
The mean number of phlebotomies during Weeks 0-32 in the rusfertide arm was reduced across subgroups, including risk status and use of concurrent cytoreductive therapy, versus the placebo arm.
62.6% of patients treated with rusfertide plus current standard of care maintained hematocrit levels below 45% versus 14.4% treated with placebo plus current standard of care (p<0.0001).1
Rusfertide also showed statistically significant improvements in mean change from baseline to Week 32 in PROMIS Fatigue2 (p<0.03) and the MFSAF Total Symptom Score3 (p<0.03). Rusfertide is the first investigational therapy to prospectively demonstrate a statistically significant improvement in these patient-reported outcomes (PROs) of fatigue and symptom burden in patients with PV.1
Rusfertide was generally well tolerated. The majority of adverse events were low grade and non-serious and no serious adverse events considered related to rusfertide were reported. There was no evidence of increased risk of cancer in patients treated with rusfertide plus current standard of care compared to patients treated with placebo plus current standard of care at the time of the primary analysis. Cancer events were reported in one patient in the rusfertide arm (0.7%) and in seven patients in the placebo arm (4.8%). The most common treatment-emergent adverse events were localized injection site reactions (55.9%), anemia (15.9%) and fatigue (15.2%).1

"These findings underscore rusfertide’s potential as a first-in-class erythrocytosis-specific treatment for PV and validate more than a decade of scientific innovation originating from Protagonist’s peptide technology platform," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist. "We would like to thank all the patients, study staff and investigators for participating in the VERIFY study. We are pleased to partner with Takeda as we continue to advance rusfertide to potentially transform the standard of care in PV patients around the world."

"These promising pivotal data strongly support rusfertide’s potential benefit for a broad spectrum of patients with PV who may be receiving current standard of care therapies but not achieving adequate hematocrit control," said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit (OTAU) at Takeda. "We look forward to receiving additional data from the VERIFY trial later this year, advancing rusfertide towards regulatory approval and continuing our collaboration with Protagonist to bring this innovative therapy to patients."

Rusfertide has received Orphan Drug designation and Fast Track designation from the U.S. Food & Drug Administration (FDA).

Takeda Investor Conference Call and Webcast Details

Takeda will host an investor call regarding this update on Sunday, June 1, 6-6:45 pm CDT/ 7-7:45 pm EDT / Monday, June 2, 08:00-08:45 (JST).

The call will be held using the Zoom platform and Zoom simultaneous interpretation function. Kindly pre-register from the below link:
View Source

An on-demand replay will be made available on Takeda’s website after the conclusion of the event.

Protagonist Investor Conference Call and Webcast Details

The dial-in numbers for Protagonist’s investor update on Monday, June 2nd at 5:00-6:00 am PDT/ 8:00-9:00 am EDT are:

US-based Investors: 1-877-300-8521
International Investors: 1-412-317-6026
Conference Call ID: 10199589
The webcast link for the event can be found here: View Source;tp_key=360d3b714d

A replay of the presentation will be available on the Protagonist Investor Relations Events and Presentations webpage following the event.

About VERIFY

The Phase 3 VERIFY study (NCT05210790) is an ongoing, three-part, global, randomized, placebo-controlled study evaluating rusfertide in 293 patients with polycythemia vera over a 156-week period. The study is evaluating the efficacy and safety of once-weekly, subcutaneously self-administered rusfertide in patients with uncontrolled hematocrit who are phlebotomy-dependent despite current standard of care treatment, which could include hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study was the proportion of patients achieving a response during Weeks 20-32, which was defined as the absence of "phlebotomy eligibility." To meet phlebotomy eligibility, patients in the study were required to have: confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or hematocrit ≥48%.

All patients have completed their participation in the randomized, placebo-controlled portion of the study evaluating the efficacy and safety of rusfertide plus current standard of care versus placebo plus current standard of care and are now in the open-label portions of the study.

Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response

On June 1, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported the first data for casdatifan plus cabozantinib in an oral presentation by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Arcus Biosciences, JUN 1, 2025, View Source [SID1234653572]).

"I was very encouraged to see that nearly half of patients had a confirmed response to the casdatifan plus cabozantinib combination despite short follow-up," said Toni K. Choueiri, M.D., director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber, the Jerome and Nancy Kohlberg Chair and professor of medicine at Harvard Medical School, and lead investigator of ARC-20. "Casdatifan plus cabozantinib was well tolerated, and the safety profile was consistent with that of either agent alone, supporting their potential as a combination therapy. I look forward to enrolling patients into the PEAK-1 trial as soon as it is open."

"The initial data for casdatifan plus cabozantinib in the ARC-20 study have already exceeded the historic benchmarks for either agent alone, as well as that of another HIF-2a inhibitor plus cabozantinib in the same second-line setting," said Terry Rosen, Ph.D., chief executive officer of Arcus. "These data serve as the proof of concept for PEAK-1, which will be initiated in the coming weeks and is designed to generate evidence to change the standard of care for people who have progressed on prior immunotherapy treatment."

ARC-20 is a Phase 1/1b dose-escalation and expansion study that includes a cohort evaluating once-daily 100mg of casdatifan plus 60mg of cabozantinib in patients with ccRCC who had progressed on prior immunotherapy. At the time of the data cutoff (DCO, March 14, 2025), 42 participants were evaluable for safety, and 24 reached at least 12 weeks of follow-up and were evaluable for efficacy. Among the safety-evaluable population (N=42), most participants (79%) had an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor of intermediate or poor. Nearly half (46%) of the efficacy-evaluable population (N=24) achieved a confirmed response per RECIST 1.1, and only one patient had primary progressive disease. The vast majority of the efficacy-evaluable population remains on treatment.

In the safety-evaluable population, no unexpected safety risks were identified at the time of DCO, and casdatifan plus cabozantinib had an acceptable safety profile with no meaningful overlapping toxicity for the two drugs. Only two patients discontinued any drug, and no patients discontinued treatment with both drugs. The incidence of treatment-emergent adverse events (TEAEs) with casdatifan, particularly anemia and hypoxia, was similar to TEAEs observed with casdatifan monotherapy, and there were no casdatifan-related Grade 4 or 5 adverse events. The incidence of TEAEs associated with each drug was consistent with what is expected for each drug alone.

A summary of the efficacy and safety results is below.

Efficacy-Evaluablea

casdatifan 100mg QD + cabozantinib 60mg QD

(n=24)

Median Follow-Up

5.3 months

Confirmed ORR (cORR) per RECIST v1.1 [95% CI]

46% (11)b

[26,67]

Best Overall Response:

Complete Response

4% (1)

Partial Response

42% (10)b

Stable Disease

50% (12)

Progressive Disease

4% (1)

CI: confidence interval; QD: daily

a All eligible patients who received any study treatment and reached a minimum of 12 weeks follow-up or discontinued due to progression or death.

b Inclusive of one patient who had partial response confirmation after March 14, 2025.

Safetya

casdatifan 100mg QD + cabozantinib 60mg QD

(n=42)

casdatifan

cabozantinib

Patients with any Treatment-Related Grade ≥3 AEb

Anemia

24% (10)

14% (6)

Hyponatremia

7% (3)

Hypoxia

7% (3)

Hypertension

5% (2)

Neutrophil count decrease

2% (1)

5% (2)

Patients with any AE leading to dose reductionb

Fatigue

2% (1)

12% (5)

Anemia

10% (4)

2% (1)

Hypoxia

10% (4)

Palmar-plantar erythrodysesthesia

5% (2)

Stomatitis

5% (2)

AE: adverse event

a Safety population included patients who received any amount of study drug and had at least one month of safety follow-up at the data cutoff date.

b Treatment-emergent adverse events (grade 3 or higher) related to casdatifan, cabozantinib, or any study drug reported in ≥3% of patients in any treatment arm.

Arcus is pursuing a broad development program in both the immuno-oncology (IO)-naive and post-IO settings with differentiated combinations to maximize the opportunity for casdatifan in ccRCC. These studies include:

Arcus’s planned Phase 3 study, PEAK-1, which will evaluate casdatifan plus cabozantinib versus cabozantinib monotherapy as a first- or second-line treatment in patients with metastatic ccRCC who have previously received anti-PD-1/PD-L1 therapy. The primary endpoint will be PFS with a key secondary endpoint of overall survival.
eVOLVE-RCC02, a Phase 1b/3 study sponsored by AstraZeneca, which will evaluate casdatifan plus volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, as first-line treatment for participants with ccRCC.
ARC-20, which includes three cohorts evaluating casdatifan in earlier-line settings, including casdatifan plus zimberelimab in first-line ccRCC, casdatifan monotherapy in favorable risk ccRCC, and casdatifan monotherapy in immunotherapy-experienced, TKI-naive settings.
Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 446724 on Monday, June 2, 2025, at 5:00 AM PT / 7:00 AM CT. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2a, casdatifan is designed to shut down hypoxic oncogenesis and key oncogenic pathways, which leads to cancer cell death. Clear cell renal cell carcinoma is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

Latest Data of InnoCare’s Robust Oncology Pipelines Presented at the 2025 ASCO Annual Meeting

On June 1, 2025 InnoCare reported latest data of robust oncology pipelines were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, involving the anti-CCR8 antibody ICP-B05 (CM369), the BCL2 inhibitor mesutoclax (ICP-248) and the pan-TRK inhibitor zurletrectinib (ICP-723) (Press release, InnoCare Pharma, JUN 1, 2025, View Source [SID1234653571]).

Oral Presentation

Title: Preliminary results from the dose-escalation stage of a phase I trial of an anti-CCR8 antibody in patients with relapsed/refractory cutaneous T-cell lymphoma (R/R CTCL) (Abstract No.: 2514)

The current study is the first and only report on the preliminary efficacy data of anti-CCR8 targeted therapy for CTCL patients. The efficacy of ICP-B05 was supported by the PD effects in both skin lesions and peripheral blood in the depletion of CCR8+ cells. ICP-B05 is safe and well tolerated and its safety profile made it a good candidate for combo therapies for CTCL patients with lymph node and other organ involvement.

As of Jan. 6, 2025, a total of 13 patients with R/R CTCL were treated. There were 12 patients received at least one skin lesion assessment followed the mSWAT. 33.3% of patients achieved PR, and 58.3% of patients were assessed as SD with reduction in skin lesion. The 6-month PFS rate was 82.5%, and the median PFS was 11.4 months.

Among the five patients with CCR8+ levels exceeding 10%, four (80%) achieved PR. PK analysis showed that serum exposure (Cmax and AUC0-14D) increased with dose escalation. PD analysis demonstrated significant depletion of CCR8-expressing cells in CTCL skin lesions.

Poster 1:

Title: Preliminary safety and efficacy data of ICP-248, a novel BCL2 inhibitor, in patients with relapsed or refractory B-cell malignancies (Abstract No.: 7038)

The results of ICP-248 monotherapy suggests a well-tolerated safety profile and an exciting efficacy in BTK failed, heavily treated, relapsed or refractory B-cell malignancies.

As of April 15, 2025, a total of 68 patients were enrolled in the dose escalation and dose expansion study. 17 R/R CLL/SLL and 32 R/R MCL patients were treated with 125 mg of ICP-248, including 10 CLL/SLL and 25 MCL patients were previously treated with BTK inhibitors, and 70.0% of CLL/SLL patients and 100% of MCL patients were resistant to BTK inhibitors.

17 CLL/SLL and 26 MCL patients had at least one response assessment. Among the BTK naïve patients, the ORR for R/R CLL/SLL and R/R MCL patients were both 100%, and the CRR was 14.3% and 71.4% respectively, of which 43% of MCL patients reported undetectable minimal residual disease (uMRD). Among the BTK treated patients, the ORR for R/R CLL/SLL and R/R MCL patients were 100% and 78.9% respectively, and the CRR were 30.0% and 26.3% respectively, of which uMRD was reported in 20% of CLL/SLL and 16% of MCL patients.

The median PFS of R/R MCL patients who had received treatment of BTK inhibitors before was 8.3 months. The PFS was not reached among BTK naïve R/R CLL/SLL and R/R MCL patients and BTK-treated R/R CLL/SLL patients.

Poster 2:

Title: Efficacy, safety and pharmacokinetics (PK) of zurletrectinib, a next-generation pan-TRK inhibitor, in pediatric and adolescent patients with NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 10048)

The integrated analysis demonstrated that zurletrectinib had significant efficacy and good safety profile in pediatric and adolescent patients with NTRK+ solid tumors. Zurletrectinib also showed the potential to overcome the resistance to first generation TRK inhibitors. These findings support zurletrectinib is a better treatment option for NTRK+ pediatric and adolescent patients.

As of Nov. 23, 2024, 18 patients in total were enrolled, including 8 pediatric patients and 10 adolescent patients. Among the 18 patients, 6 TRK inhibitor treatment-naïve patients with central lab confirmed NTRK+ were efficacy evaluable. The confirmed ORR assessed by IRC was 100%.

All patients achieved partial response (PR) at the first tumor assessment and maintained the remission as of the cutoff date. Median time to response were 1.0 month in adolescent patients and 0.9 month in pediatric patients. It is worth noting that one pediatric patient who progressed on prior first-generation TRK inhibitor achieved complete response after receiving zurletrectinib.

Poster 3:

Title: Updated efficacy and safety of zurlectrectinib in adult patients (pts) with locally advanced or metastatic NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 3112)

In line with previously reported results, zurletrectinib continued to demonstrate a deep and durable responses in adult patients with NTRK+ advanced solid tumors with or without brain metastasis. Zurletrectinib was also well-tolerated and showed favorable safety profile in adult patients with various tumor types.

As of Nov. 23, 2024, a total of 49 TRK inhibitor naïve adult patients were evaluable for efficacy representing 12 different solid tumor types. Among the efficacy population, the distribution of NTRK1, NTRK2 and NTRK3 fusions was 53.1%, 2.0% and 44.9% respectively.

The confirmed ORR by IRC was 83.7%, with CR of 10.2%. Median duration of response (DOR) and median progression-free survival (PFS) by IRC were not reached. The DOR rate and PFS rate by IRC at 12 months was 92.0% and 90.5% respectively. Two of the three patients who had brain metastasis at the baseline achieved intracerebral ORR, which is consistent with the good brain penetration and strong intracranial activity of zurletrectinib.

The 2025 ASCO (Free ASCO Whitepaper) Annual Meeting is held from May 30 to June 3, 2025 in Chicago, U.S. The ASCO (Free ASCO Whitepaper) annual meeting is the most important and professional academic event in the global oncology field, which showcases the international cutting-edge clinical oncology research results and tumor treatment technologies.

InxMed Announces Promising Phase Ib/II Clinical Data for Ifebemtinib + KRAS G12C inhibitor in KRAS G12C-Mutant Solid Tumors at ASCO 2025

On June 1, 2025 InxMed Co., Ltd, a clinical-stage biotechnological company, pioneering therapies to transform cancer treatment, reported latest clinical data from a Phase Ib/II clinical trial (NCT06166836; NCT05379946) to evaluate the efficacy and safety of ifebemtinib (IN10018), an oral focal adhesion kinase (FAK) inhibitor in combination with garsorasib (D-1533), an oral KRAS G12C inhibitor, in KRAS G12C mutant solid tumors (Press release, InxMed, JUN 1, 2025, View Source;kras-g12c-inhibitor-in-kras-g12c-mutant-solid-tumors-at-asco-2025-302470109.html [SID1234653570]).

The clinical data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #8629 | Poster Board #109) included results from two cohorts:

Durability follow-up data of the single-arm cohort in first-line KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 expression, who received ifebemtinib + garsorasib treatment.
A randomized cohort in previously treated KRAS G12C-mutant colorectal cancer (CRC) patients comparing ifebemtinib+ garsorasib versus garsorasib monotherapy.
In NSCLC cohort, the combination of ifebemtinib and garsorasib, as a dual-oral, chemotherapy-free regimen, demonstrated compelling clinical benefit including high response rates and durable efficacy, regardless of PD-L1 expression, and in CRC cohort, the result showed clear add-on efficacy by ifebemtinib compared to KRAS inhibitor monotherapy.

Key Highlights in First-line NSCLC: Dual-Oral Regimen Shows Durable Efficacy and Emerging Survival Benefit

As of March 31, 2025, 33 first-line NSCLC patients, regardless of PD-L1 expression, were enrolled and received the combination of ifebemtinib and garsorasib, with a median follow-up of 16.0 months. Previously the company has reported an Objective Response rate (ORR) of 90.3% (data presented at ESMO (Free ESMO Whitepaper) 2024). The follow-up data were now summarized as follows:

Median progression-free survival (mPFS): 22.3 months
Median duration of response DOR (mDOR): 19.4 months
Median overall survival (mOS): not yet reached, with a significant uplifting and flattening survival curve indicating durable benefit.
Of note, the treatment demonstrated consistent efficacy regardless of PD-L1 expression status.

Key Findings in Previously Treated CRC: Randomized Trial Validates Synergy with KRAS G12Ci

As of Apr 21, 2025, 36 previously treated CRC patients were randomized 1:1 to receive the combination of ifebemtinib + garsorasib or garsorasib alone. All patients were radiologically evaluable and the antitumor responses were assessed and summarized as follows:

ORR: 44.4% (combo) vs. 16.7% (mono)
Disease control rate (DCR): 100.0% (combo) vs. 77.8% (mono)
mPFS: 7.7 months (combo) vs. 4.0 months (mono)
mOS: not yet reached in the combination arm; early separation observed in the survival curves
"These results validate ifebemtinib as an ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy of RASi significantly," said Dr. Zaiqi Wang, Chief Executive Officer of InxMed. "The unprecedented 19-month DOR and 22-month median PFS in front-line NSCLC in all comers and near doubling of response rate in CRC position this dual-oral regimen as a potential paradigm shift treatment in KRAS G12C-mutant cancers. Its favorable safety profile further supports the potential for a cytotoxic chemotherapy-free regimen in winning front-line in the future."

InxMed has initiated a randomized Phase III pivotal trial in first-line KRAS G12C-mutant NSCLC. Additionally, the company is actively exploring combinations of ifebemtinib with other KRAS-targeted agents, including KRAS G12D inhibitors and multi-RAS inhibitors, supported by promising preclinical synergy data.

About Ifebemtinib (IN10018)

Ifebemtinib (IN10018) is a highly selective, orally administered, small molecule inhibitor against FAK, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, it has demonstrated therapeutic synergies with chemotherapy, targeted therapies, and immunotherapies. To date, over 600 patients have been treated with a favorable safety and tolerability profile.

Ifebemtinib has been granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track Designation from the U.S. Food and Drug Administration (FDA). A New Drug Application submission to the NMPA is planned for 2025.