ARV-806 / Arvinas - LARVOL DELTA

ARV-806-101: A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=76 | Active, not recruiting | Sponsor: Arvinas Inc. | N=159 ➔ 76

Enrollment change • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Preclinical Efficacy of ARV-806, a PROTAC KRAS G12D Degrader, in Combination With Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibodies (mAbs) in KRAS G12D–Mutated Colorectal Cancer (CRC) Models (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Combination therapy • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • EGFR • KRAS

Preclinical Efficacy of ARV-806, a PROTAC KRAS G12D Degrader, in Combination With the RAS-ON Multi-Selective Inhibitor Daraxonrasib in KRAS G12D–Mutated Models (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Combination therapy • Preclinical • Oncology • KRAS

Preclinical Efficacy of ARV-806, a PROTAC KRAS G12D Degrader, in Combination With Chemotherapy in KRAS G12D–Mutated Pancreatic Cancer Models (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Combination therapy • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

ARV-806, a PROTAC KRAS G12D Degrader, in Patients With KRAS G12D–Mutated Advanced Solid Tumors: Preliminary Phase 1 Results (EORTC-NCI-AACR 2026) - "Abstract will be available on the day of the presentation"

Clinical • Metastases • P1 data • Oncology • Solid Tumor • KRAS

ARV-806-101: A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=159 | Active, not recruiting | Sponsor: Arvinas Inc. | Trial completion date: Apr 2029 ➔ Nov 2026 | Trial primary completion date: Nov 2027 ➔ Nov 2026

Trial completion date • Trial primary completion date • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

ARV-806: Novel PROTAC KRAS G12D degrader (GlobeNewswire) - "Reiterated plan to share initial data from the Phase 1 monotherapy dose escalation clinical trial in the second half of 2026; Announced plans to seek an out-licensing agreement for any additional clinical trials, including dose expansion or combination clinical trials."

Licensing / partnership • P1 data • Pancreatic Ductal Adenocarcinoma • Solid Tumor

ARV-806-101: A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=159 | Active, not recruiting | Sponsor: Arvinas Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

ARV-806: Novel PROTAC KRAS G12D degrader (The Manila Times) - "Initiate enrollment in the dose expansion cohort of the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731); Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026)."

Enrollment status • P1 data • Pancreatic Ductal Adenocarcinoma

ARV-806-101: A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=159 | Recruiting | Sponsor: Arvinas Inc. | N=51 ➔ 159

Enrollment change • Trial initiation date • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

ARV-806-101: A Study to Evaluate the Safety and Tolerability of ARV-806 in Adults with Advanced Cancer that has the KRAS G12D Mutation (clinicaltrialsregister.eu) - P1 | N=14 | Not yet recruiting | Sponsor: Arvinas Operations Inc.

New P1 trial • Oncology • Solid Tumor • KRAS

ARV-806-101: A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=51 | Recruiting | Sponsor: Arvinas Inc. | N=14 ➔ 51

Enrollment change • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Completed dose escalation for once-weekly administration ahead of plan based on faster-than-anticipated enrollment in the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731). (GlobeNewswire)

Trial status • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Anticipated Upcoming Milestones and Expectations (GlobeNewswire) - "Continue enrollment in the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731); Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026)...Anticipate sharing updated clinical data from the ongoing Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin’s lymphoma (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026); Initiate enrollment of a combination cohort with glofitamab in patients with DLBCL in the ongoing Phase 1 clinical trial (1H 2026)....Identify and select a partner with the capabilities and expertise to maximize the commercial potential of vepdegestrant; Advance towards Prescription Drug User Fee Act (PDUFA) action date on June 5, 2026."

Clinical data • Commercial • PDUFA • Trial status • Angioimmunoblastic T-cell Lymphoma • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Non-Hodgkin’s Lymphoma • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Phase 1/2 study of ARV-806, a PROTAC KRAS G12D degrader, in KRAS G12D–mutated advanced solid tumors, including pancreatic cancer. (ASCO-GI 2026) - P1/2 | "Primary endpoints of phase 1 are dose-limiting toxicities during the first cycle and adverse events to determine the maximum tolerated dose (MTD; or maximum administered dose if MTD not reached) and to select recommended phase 2 dose(s) (RP2Ds) for cohort expansion. In phase 2, patients will receive ARV-806 at one or more doses selected from phase 1 to evaluate its antitumor activity and support further RP2D optimization."

First-in-human • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

ARV-806: Novel PROTAC KRAS G12D degrader (Arvinas Press Release) - "Continue enrollment in the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731); Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026)."

P1 data • Solid Tumor

Arvinas Presents Preclinical Data for ARV-806 Demonstrating Robust and Differentiated Activity in Models of KRAS G12D-mutated Cancer at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "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 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."

Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Arvinas to Present Preclinical Data for ARV-806, a PROTAC KRAS G12D Degrader, at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire)

Preclinical • Solid Tumor

Preclinical activity of ARV-806, a PROTAC KRAS G12D degrader (AACR-NCI-EORTC 2025) - P1/2 | "Additionally, in the mutant KRAS CT26 syngeneic in vivo model, robust single-agent activity was observed as well as strong synergy with immune checkpoint blockade, all resulting in antitumor immunological memory. These combined observations suggest that PROTAC KRAS degraders may be particularly adept at attacking tumors by both eliminating the key oncogenic driver protein and by activating an antitumor immune response."

IO biomarker • Preclinical • Colorectal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BCL2L11 • KRAS • MYC

Arvinas Reports Second Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Added a combination cohort of vepdegestrant plus Pfizer’s KAT6 inhibitor (PF-07248144) to Pfizer’s ongoing Phase 1 clinical trial (ClinicalTrials.gov Identifier: NCT04606446)....ARV-393: Oral PROTAC BCL6 degrader: Continued recruiting patients in the first-in-human Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL) (ClinicalTrials.gov Identifier: NCT06393738)....ARV-806: Novel PROTAC KRAS G12D degrader: Initiated enrollment in the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731)."

Trial status • Castration-Resistant Prostate Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Solid Tumor

Arvinas Reports Second Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "ARV-393: Oral PROTAC BCL6 degrader - Share preclinical data in combination with glofitamab in models of aggressive high grade DLBCL (2H 2025). Share preliminary clinical data from the ongoing Phase 1 clinical trial in patients with NHL (ClinicalTrials.gov Identifier: NCT06393738) (2H 2025). ARV-806: Novel PROTAC KRAS G12D degrader - Share preclinical data from the clinical stage ARV-806 program (2H 2025)."

P1 data • Preclinical • Diffuse Large B Cell Lymphoma • Non-Hodgkin’s Lymphoma

A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=159 | Recruiting | Sponsor: Arvinas Inc.

New P1/2 trial • Oncology • Solid Tumor • KRAS

Anticipated Upcoming Milestones and Expectations (GlobeNewswire) - "Share data with global regulatory authorities to potentially support regulatory filings (2Q 2025) and submit new drug application to the U.S. Food and Drug Administration for potential approval (2H 2025); Add a combination cohort of vepdegestrant plus Pfizer’s KAT6 inhibitor (PF-07248144) to Pfizer’s ongoing Phase 1 trial (NCT04606446)....ARV-806: Novel PROTAC KRAS G12D degrader: Initiate a first-in-human Phase 1 trial in patients with solid tumors harboring KRAS G12D mutations (2H 2025)."

FDA filing • Filing • New P1 trial • Trial status • Solid Tumor

Arvinas Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "ARV-393: Oral PROTAC BCL6 degrader: Present preclinical data of ARV-393 in combination with standard of care biologic agents and small molecule inhibitors in high grade and aggressive diffuse large B-cell lymphoma in vivo models at the American Association for Cancer Research Annual Meeting (April 25-30, 2025). Disclose preliminary data from the ongoing Phase 1 clinical trial in patients with NHL (ClinicalTrials.gov Identifier: NCT06393738) in 2025....Novel PROTAC KRAS G12D degrader: File an Investigational New Drug (IND) application in 2025."

IND • P1 data • Preclinical • Diffuse Large B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Solid Tumor

Arvinas…Highlights Upcoming Milestones, and Provides Corporate Update (GlobeNewswire) - "ARV-393: Oral PROTAC BCL6 degrader - Present initial data from the ongoing Phase 1 clinical trial in patients with B-cell lymphomas (NCT06393738). Novel PROTAC KRAS G12D degrader: File an Investigational New Drug (IND) application."

IND • P1 data • Non-Hodgkin’s Lymphoma • Oncology