On October 24, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. Kura and Kyowa Kirin announced the launch of the KOMET-017 trials on September 29, 2025.

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KOMET-017 (NCT07007312) comprises two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). Kura believes KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings.

(Press release, Kura Oncology, OCT 24, 2025, View Source [SID1234656976])

On October 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2025.

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Chugai reported increased revenue and operating profit year-on-year for the third quarter (Core-basis).

Regarding revenue, domestic sales increased by 3.6%. In the oncology field, sales increased by 0.2%. While our mainstay product Avastin was affected by NHI drug price revisions and generics, this was offset by steady growth of new products Phesgo, Lunsumio, and our mainstay product Polivy. In the specialty field, sales increased by 7.7%, driven by steady performance of mainstay products Vabysmo, Hemlibra, and Enspryng, along with successful market penetration of the new product PiaSky. Overseas sales increased by 7.7%, driven by a substantial increase in exports of Actemra to Roche. Other revenue decreased by 0.9%, despite the increase in income related to Hemlibra, mainly due to a decrease in one-time income.

Cost to sales ratio increased by 0.6 percentage points year-on-year to 33.1%, mainly due to changes in the product mix. Research and development expenses increased by 0.7% due to investments into drug discovery and early development, and increases associated with the progress of development projects, while selling, general and administrative expenses decreased by 4.3% mainly driven by various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥450.5 billion (+5.6%) with a Core operating profit margin (to revenue) of 49.4%.

Chugai made good progress in both in-house products and products in-licensed from Roche.

For in-house products, PiaSky was launched in Taiwan as the first subcutaneous formulation for paroxysmal nocturnal hemoglobinuria. Enspryng has obtained results from Phase III clinical trials for thyroid eye disease, and will be discussed with health authorities. For Chugai originated project, Orforglipron, an oral GLP-1 receptor agonist out-licensed to Eli Lilly, met primary endpoints in multiple Phase III clinical trials for obesity and type 2 diabetes.

For products in-licensed from Roche, Tecentriq has obtained approval for an expanded indication for relapsed or refractory extranodal NK/T-cell lymphoma, nasal type. Avastin has been filed for an expanded indication for neurofibromatosis type II. Glofitamab has initiated Phase II clinical trials in Japan for both relapsed or refractory diffuse large B-cell lymphoma and relapsed or refractory mantle cell lymphoma. Additionally, afimkibart has initiated Phase III clinical trial for Crohn’s disease, and divarasib initiated Phase Ib/II clinical trial for non-small cell lung cancer (first-line treatment). Furthermore, Chugai has in-licensed CT-388, a long-acting GLP-1/GIP receptor agonist, from Roche.

[2025 third quarter results]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Core results
Revenue 911.6 868.5 +5.0%
　Sales 794.6 750.3 +5.9%
　Other revenue 117.1 118.2 -0.9%
Operating profit 450.5 426.6 +5.6%
Net income 320.0 301.3 +6.2%
IFRS results
Revenue 911.6 868.5 +5.0%
Operating profit 429.8 418.6 +2.7%
Net income 305.6 295.8 +3.3%
[Sales breakdown]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Sales 794.6 750.3 +5.9%
Domestic sales 343.7 331.7 +3.6%
　Oncology 180.7 180.3 +0.2%
　Specialty 163.0 151.3 +7.7%
Overseas sales 450.9 418.7 +7.7%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Tecentriq 46.0 47.4 -3.0%
Polivy 27.0 24.5 +10.2%
Phesgo 24.5 15.0 +63.3%
Alecensa 24.3 22.4 +8.5%
Avastin 19.6 25.6 -23.4%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Hemlibra 44.7 41.5 +7.7%
Actemra 36.7 34.8 +5.5%
Enspryng 20.9 17.8 +17.4%
Vabysmo 18.5 14.7 +25.9%
Evrysdi 12.0 11.3 +6.2%
[Progress in R&D activities from Jul 25th, 2025 to Oct 24th, 2025]

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, OCT 24, 2025, View Source [SID1234656975])

On October 24, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported preclinical data for ARV-806, a PROTAC KRAS G12D degrader, at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, Massachusetts. The ARV-806 data presented show a differentiated profile based on degradation potency, antiproliferative activity, and induction of cancer cell death. ARV-806 is designed to target both the ON and OFF forms of KRAS G12D, which is the most common mutation of the KRAS protein. ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and non-small cell lung cancer.

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"These data suggest the potential of targeted protein degradation to overcome historical limitations in addressing undruggable KRAS mutations," said Angela Cacace, Ph.D., Chief Scientific Officer of Arvinas. "ARV-806’s ability to eliminate both ON and OFF forms of KRAS G12D, combined with its potency and durability shown in preclinical models, supports our confidence in its clinical potential to deliver meaningful benefit for patients with KRAS G12D-mutated cancers."

Key highlights from the presentation include:

In vitro, ARV-806 degraded KRAS G12D with picomolar potency across pancreatic, colorectal, and lung cancer cell lines but did not induce degradation of wild-type and other mutant RAS isoforms.
ARV-806 is differentiated from other KRAS G12D targeting agents in development and has potential to be a best-in-class therapy for KRAS G12D mutated cancers due to:
Catalytic activity, which allows it to overcome upregulation, a common mechanism of resistance to inhibitor treatment
Compared with clinical-stage KRAS G12D ON and OFF inhibitors and another clinical-stage G12D degrader, ARV-806 demonstrated:
>25-fold greater potency in reducing cancer cell proliferation,
>40-fold higher potency in degrading KRAS G12D protein (versus the comparable clinical-stage G12D degrader), and
>10-fold lower concentrations required to induce pro-apoptotic BIM expression.
Following a single intravenous dose in a colorectal tumor xenograft model, ARV-806 degraded >90% of KRAS G12D for seven days, with parallel suppression of c-MYC (a key driver of cancer cell proliferation) and induction of BIM (Bcl-2-interacting mediator of cell death, a pro-apoptotic factor) for ≥5 days.
ARV-806 demonstrated robust efficacy responses at low doses in tumor models including: ≥30% tumor volume reductions in pancreatic and colorectal cell line-derived xenograft (CDX) models and a patient-derived xenograft (PDX) model of lung cancer.

These data demonstrate sustained pharmacodynamic activity consistent with long-lasting target degradation, which we believe supports intermittent clinical dosing. Arvinas is currently evaluating ARV-806 in a Phase 1 clinical trial in patients with KRAS G12D–mutated advanced solid tumors (NCT07023731).

Also shown in the poster, orally bioavailable pan-KRAS degraders have been identified that potently degrade multiple variants of KRAS and spare other RAS isoforms. A tool pan-KRAS PROTAC demonstrated robust single-agent activity and superior combination efficacy with immune checkpoint blockade compared with a pan-RAS ON inhibitor (7 complete responses compared with 2 complete responses).

About ARV-806
ARV‑806 is a novel, investigational PROTAC degrader designed to selectively target and degrade mutant Kirsten rat sarcoma (KRAS) G12D which is the most common mutation of the KRAS protein. Therefore, ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and lung cancer. ARV‑806 is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors harboring KRAS G12D mutations.

(Press release, Arvinas, OCT 24, 2025, View Source [SID1234656974])

On October 24, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported an update on the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) study. The latest results show that, at the 100 mg APR-1051 dose level, 3 out of 4 patients achieved stable disease, as measured using RECIST v1.1 criteria.

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A poster titled Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT-1051 Phase 1 trial will be presented today at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The poster, to be presented by Drs. Timothy Yap MBBS, PhD, FRCP, University of Texas MD Anderson Cancer Center and lead investigator of the study, and Philippe Pultar, MD, Senior Medical Advisor at Aprea, summarizes preliminary results from the trial with a cutoff date of September 17, 2025. A copy of the poster will be available on Investors page of the Aprea corporate website under "Investor Presentations & Resources."

"We continue to be encouraged by these early clinical findings, which demonstrate signals of anti-tumor activity with APR-1051 in a heavily pre-treated patient population," said Dr. Pultar. "We believe the observation of disease control in tumors harboring FBXW7, CCNE1, and KRAS mutations align with our mechanistic understanding of WEE1 inhibition and reinforces the scientific rationale for APR-1051 development. We believe these promising data provide an important foundation as we continue with dose escalation in the ongoing study and we look forward to providing further updates as we advance to higher dose level in the ongoing study."

ACESOT-1051 Clinical Update (data cutoff October 19, 2025)

The primary objective of the trial is to characterize the safety profile, dose-limiting toxicity, maximum tolerated dose or maximum administered dose, and recommended Phase 2 dose of APR-1051. Secondary objectives are to 1) to characterize the pharmacokinetics of APR-1051 and the major metabolites and active metabolites of APR-1051, and 2) to assess preliminary efficacy of APR-1051
Results from Dose Level 6 (100 mg), show 3 out of 4 patients achieved stable disease, per RECIST v1.1 in heavily pretreated gastrointestinal and gynecologic malignancies
Disease stabilization was observed in patients with FBXW7, CCNE1, and KRASG12V + TP53 alterations
Favorable tolerability: No dose limiting toxicities (DLTs) or unexpected safety issues reported to date.
Following successful clearance of the 100 mg cohort, dose escalation has progressed to Dose Level 7 (150 mg)
For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

Individual Patient Results

86-year-old female with rectal cancer: Treated at a 100 mg dose after five prior lines, the patient achieved stable disease (-13% reduction). Tumor harbored FBXW7 mutation which is a mechanistically relevant biomarker for WEE1 inhibition. 145 days on treatment and ongoing
55-year-old male with rectal cancer: Treated at a 100 mg dose after four prior lines, the patient achieved stable disease (+1%). Tumor harbored KRASG12V + TP53-mutant patient supports mechanistic activity in this genotype. 63 days on treatment and ongoing
73-year-old female with endometrial cancer: Treated at a 100mg after five prior lines, patient achieved stable disease by RECIST v1.1 criteria (+15%) at the first evaluation before voluntarily withdrawing consent after approximately two months of treatment. Tumor harbored CCNE1 and TP53 mutations supports mechanistic activity in this genotype.
50-year-old female with colon cancer: Treated at 100mg after two prior lines. This patient had disease progression at first assessment (8 weeks).

(Press release, Aprea, OCT 24, 2025, View Source [SID1234656973])

On October 23, 2025 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported positive data from its ongoing Phase 1/2 study of vopimetostat (TNG462) in patients with MTAP-deleted cancers.

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"Today, we are presenting a substantive dataset on our lead PRMT5 inhibitor vopimetostat, which has the potential to be a turning point for treatment of multiple difficult-to-treat MTAP-del cancers, beginning with pancreatic cancer," said Barbara Weber, M.D., President and CEO of Tango Therapeutics. "Across the 16 cancer types enrolled in the trial, the ORR is 27% in patients with a median follow-up of 9.4 months, which supports the potential for vopimetostat as the best-in-class PRMT5 inhibitor. In 2L MTAP-deleted pancreatic cancer, the median PFS is 7.2 months and the ORR is 25%, more than double that observed in historical control studies, supporting our decision to initiate a pivotal trial in this patient population in 2026. With FDA alignment on the go-forward dose of 250 mg QD, we anticipate that this study will enroll rapidly, underscoring the potential for vopimetostat to be the first MTAP-selective PRMT5 inhibitor to market."

Dr. Weber continued, "Our ongoing study of vopimetostat in combination with two Revolution Medicines (RVMD) RAS(ON) inhibitors is enrolling rapidly and we anticipate sharing safety and efficacy data from that study in 2026. Today, we also announced data from the histology-agnostic cohort of the vopimetostat phase 1/2 trial, where we observed a 49% ORR and mPFS of 9.1 months (excluding sarcoma). These data from the histology agnostic cohort demonstrate the potential of vopimetostat in multiple cancers in addition to pancreatic and lung cancer and provide further optionality for clinical development in a large patient population with high unmet need. In summary, the efficacy data we have provided, supported by a favorable tolerability profile to date, reinforce the potential for vopimetostat to be the first- and best-in-class PRMT5 inhibitor for patients with a wide range of MTAP-deleted cancer types."

"Current standard of care for patients with advanced pancreatic cancer is multi-agent chemotherapy that confers modest benefit along with side effects that can adversely affect patient quality of life," said Brian Wolpin, M.D., M.P.H., Director, Gastrointestinal Cancer Center and Hale Family Center for Pancreatic Cancer Research, Dana-Farber Cancer Institute. "These initial data support the potential of vopimetostat to meaningfully change the treatment of patients with advanced pancreatic cancer by providing more durable benefit, along with a better safety and tolerability profile, and the convenience of a once-daily pill as opposed to intravenous chemotherapy."

Efficacy Results Across Study Indications:

As of September 1, 2025, 179 patients were enrolled across all histologies, with 154 at active doses (200 mg and above). Ninety-four tumor evaluable patients were enrolled more than 6 months prior to the efficacy analysis and included regardless of outcome. Across cancer types:
ORR: 27%
DCR: 78%
mPFS: 6.4 months
37/94 patients remained on treatment as of September 1, 2025.
Efficacy Results in Pancreatic Cancer Patients

As of September 1, 2025, 64 patients with pancreatic cancer were enrolled. 39 of these patients received active doses and were enrolled more than 6 months prior to the analysis; in these patients:
ORR in 2L pancreatic cancer patients: 25%
ORR for all pancreatic cancer patients: 15%
DCR for all pancreatic cancer patients: 71%
mPFS in 2L patients: 7.2 months
mPFS in 3L+ patients: 4.1 months
Median follow up: 7.8 months
Development Strategy in Pancreatic Cancer

Following consultation with the FDA on the trial design scheduled later this quarter, the company plans to start a global, randomized, pivotal study in patients with MTAP-del pancreatic cancer who have received one prior line of therapy, comparing patients treated with 250 mg QD vopimetostat to patients treated with one of four standard chemotherapy regimens. The company anticipates this study will enroll approximately 300 patients and is intended to begin enrollment in 2026.
The phase 1/2 combination study of vopimetostat with RAS(ON) multi-selective inhibitor daraxonrasib, and RAS(ON) G12D-selective inhibitor zoldonrasib (both from Revolution Medicines, RVMD), is ongoing with robust enrollment in previously treated MTAP-del/RAS mut pancreatic and lung cancer. The first dose escalation cohort of this study has been fully enrolled (n=7) and backfill is ongoing. Vopimetostat in combination with both daraxonrasib and zoldonrasib have been well-tolerated to date with exposures in the active range for each compound. The second cohort was initiated in early October. A cohort of 1L patients is expected to begin enrolling after go-forward doses have been selected. The data from this study have the potential to support a pivotal study in 1L MTAP-del/RAS mut pancreatic cancer. Initial data from the Phase 1/2 study are anticipated in 2026.
Enrollment in Lung Cancer

As of September 1, 2025, 41 patients with 2L+ lung cancer were enrolled, 12 of whom had received active doses and were enrolled more than 6 months prior to the analysis.
Emerging data are consistent with expectations, and the company anticipates providing a safety and efficacy update in 2026.
Efficacy Results in the Histology Agnostic Cohort:

As of September 1, 2025, 41 patients with 13 different cancers were enrolled at active doses and had received a first dose more than 6 months prior to the analysis. This cohort excludes pancreatic and lung cancers (being evaluated in histology-specific cohorts) and sarcomas (where no activity was observed, n=0/9 responses). In this histology agnostic cohort:
ORR: 49%
DCR: 89%
mPFS: 9.1 months
Safety and Tolerability
Consistent with previously reported data, vopimetostat is generally well tolerated at 250 mg QD, the go-forward dose agreed with the FDA, with a potentially best-in-class safety profile. The most common treatment-related adverse events (TRAEs), predominantly grade 1, were nausea (26%), anemia (20%), fatigue (19%), dysgeusia (19%) and thrombocytopenia (13%). No treatment-related Grade 4 or 5 events occurred. Grade 3 events were rare, with the exception of anemia which was observed in 13% of patients. No drug related dose discontinuations have occurred as of September 1, 2025, and only 8% of patients treated at 250 mg QD required dose reduction to 200 mg QD.

Study Design
The Phase 1/2 study (NCT05732831) is a multicenter, open-label, first in human study in solid tumor patients whose tumor has a confirmed homozygous MTAP deletion. The first part of the study was an open-label, dose escalation and the second part is an open label dose expansion/optimization in specific MTAP-deleted tumor types.

Investor Webcast and Conference Call Information
The company will host a conference call to discuss these data at 8:30 a.m. ET today, October 23, 2025. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.tangotx.com. The webcast will be available for replay for at least 30 days on the company website. Analysts who wish to join the teleconference and participate in Q&A should register here.

About Vopimetostat
Vopimetostat is a potentially best-in-class oral, once-daily, MTA-cooperative PRMT5 inhibitor that works selectively in cancer cells with MTAP (methylthioadenosine phosphorylase) deletion. MTAP deletions occur in 10-15% of all human cancers, including approximately 35% of pancreatic cancer and 15% of lung cancer. Vopimetostat is being evaluated as a monotherapy and in combination clinical studies. In ongoing clinical studies, vopimetostat has demonstrated a favorable safety and tolerability profile to date and shown durable activity in multiple tumor types.

(Press release, Tango Therapeutics, OCT 23, 2025, View Source [SID1234662278])