ERAS-601 / Erasca, UT MD Anderson Cancer Center - LARVOL DELTA

A Study of ERAS-601 in People With Chordoma (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

Monotherapy • New P1/2 trial • Chordoma • Solid Tumor

FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Erasca, Inc. | Trial completion date: Jul 2025 ➔ Feb 2026 | Trial primary completion date: May 2025 ➔ Nov 2025

Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Erasca, Inc. | Trial completion date: May 2024 ➔ Jul 2025 | Trial primary completion date: May 2024 ➔ May 2025

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

HERKULES-1: A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Active, not recruiting | Sponsor: Erasca, Inc. | Phase classification: P1b/2 ➔ P1/2 | Trial completion date: Nov 2024 ➔ Nov 2025 | Trial primary completion date: May 2024 ➔ May 2025

Combination therapy • Metastases • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Preliminary results from FLAGSHP-1: A phase 1 study of ERAS-601 as a monotherapy or in combination with cetuximab in patients (pts) previously treated for advanced chordoma. (ASCO 2024) - P1 | "The most common toxicities observed for the ERAS-601 + cetuximab combination were dermatologic, which were reversible. Encouraging preliminary activity was seen in advanced, refractory chordoma. 1."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Chordoma • Dental Disorders • Dermatitis • Dermatology • Fatigue • Hematological Disorders • Immunology • Infectious Disease • Stomatitis • Thrombocytopenia

Erasca Announces Three Presentations at the 2024 ASCO Annual Meeting (GlobeNewswire) - "Erasca...announced the company will present one oral presentation and two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting....Oral presentation will feature updated HERKULES-3 results for ERK1/2 inhibitor ERAS-007 in combination with encorafenib and cetuximab in BRAFm colorectal cancer. Poster presentations will feature SEACRAFT-1 Phase 1 trial design for naporafenib plus trametinib in RAS Q61X mutations, and preliminary FLAGSHP-1 Phase 1 results for ERAS-601 and cetuximab in chordoma."

P1 data • P1/2 data • Trial status • Chordoma • Colorectal Cancer

FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Erasca, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Erasca Achieves Key Milestones for Naporafenib and ERAS-801 Programs and Extends Cash Runway (GlobeNewswire) - "As such, we are deprioritizing our ERAS-601 clinical trial (FLAGSHP-1) and our preclinical ERAS-5 ULK inhibitor and ERAS-10 protein degrader programs."

Pipeline update • Trial status • Oncology • Solid Tumor

Erasca Reports Second Quarter 2023 Financial Results and Business Updates (Yahoo Finance) - "SEACRAFT-1: Phase 1b trial for naporafenib plus trametinib in patients with RAS Q61X tissue agnostic solid tumors; Dosing of the first patient expected in the second half of 2023; Initial Phase 1b combination data expected between the second and fourth quarters of 2024; SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma; Dosing of the first patient expected in the first half of 2024; HERKULES-3: Phase 1b trial for ERAS-007 plus EC in EC-naïve patients with BRAFm CRC; Phase 1b combination expansion data in patients with BRAFm CRC expected between the second half of 2023 and the first half of 2024; FLAGSHP-1: Phase 1b trial for ERAS-601 in patients with advanced solid tumors; Phase 1b combination expansion data in relevant patient populations, including patients with human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC), expected in the first half of 2024..."

P1 data • Trial status • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

HERKULES-2: A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC (clinicaltrials.gov) - P1b | N=24 | Completed | Sponsor: Erasca, Inc. | Active, not recruiting ➔ Completed | N=200 ➔ 24 | Trial completion date: Mar 2024 ➔ Apr 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

HERKULES-1: A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1b/2 | N=200 | Active, not recruiting | Sponsor: Erasca, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Oncology • Solid Tumor

Preliminary dose escalation results of ERAS-601 in combination with cetuximab in FLAGSHP-1: a phase I study of ERAS-601, a potent and selective SHP2 inhibitor, in patients with previously treated advanced or metastatic solid tumors (AACR 2023) - "ERAS-601 in combination with cetuximab in patients with previously treated advanced or metastatic solid tumors shows promising preliminary safety and tolerability with reversible and manageable TRAEs. Further evaluation in relevant tumor types are ongoing."

Clinical • Combination therapy • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Erasca Presents Promising Initial Phase 1b Dose Escalation Data from FLAGSHP-1 for ERAS-601 Plus Cetuximab in Patients with Advanced Solid Tumors at the 2023 AACR Annual Meeting (GlobeNewswire) - P1 | N=200 | FLAGSHP-1 (NCT04670679) | Sponsor: Erasca, Inc. | "Erasca, Inc...today presented promising initial Phase 1b dose escalation data from FLAGSHP-1 for ERAS-601 in combination with cetuximab (ERBITUX®) in patients with advanced solid tumors as part of a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida....ERAS-601 in combination with cetuximab shows promising preliminary safety and tolerability with reversible and manageable treatment-related adverse events (TRAEs). Only grade 1 or 2 TRAEs occurred at or below the combination MTD for ERAS-601....Initial Phase 1b dose expansion data in HPV-negative HNSCC tumors (NCT04670679) is expected in H1 2024."

P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Erasca Reports Fourth Quarter 2022 and Full Year 2022 Financial Results and Business Updates (Businesswire) - "Key Upcoming Anticipated Milestones: (i) HERKULES-1: Phase 1b trial for ERAS-007 plus ERAS-601 in patients with advanced solid tumors - Initial Phase 1b combination data expected in first half of 2024; (ii) HERKULES-2: Phase 1b trial for ERAS-007 in patients with advanced non-small cell lung cancer (NSCLC) - Initial Phase 1b combination data in first half of 2023; Phase 1b combination expansion data in BRAF-mutated CRC between the second half of 2023 and the first half of 2024; (iii) FLAGSHP-1: Phase 1b trial for ERAS-601 in patients with advanced solid tumors - Phase 1b combination data in human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC) in first half of 2024."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • BRAF

Erasca Announces Poster Presentation at the 2023 AACR Annual Meeting (GlobeNewswire) - "Erasca...announced the company will present a poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting, taking place April 14-19, 2023, in Orlando, Florida....Poster will feature preliminary Phase 1 dose escalation data for potential best-in-class SHP2 inhibitor ERAS-601 in combination with cetuximab."

P1 data • Oncology • Solid Tumor

Preliminary results from FLAGSHP-1: A Phase I dose escalation study of ERAS-601, a potent SHP2 inhibitor, in patients with previously treated advanced or metastatic solid tumors (AACR-NCI-EORTC 2022) - " FLAGSHP-1 is the first-in-human, open-label, multicenter clinical study of ERAS-601 administered as monotherapy and in combination with cetuximab in patients with advanced or metastatic solid tumors. ERAS-601 shows promising preliminary safety and tolerability with reversible TRAEs that are manageable and consistent with the known mechanism of action for the SHP2 inhibitor class. Observed PK properties and AE profile support continued development in combination with other anti-cancer therapies, which continue to be investigated alongside additional intermittent dosing schedules."

Clinical • P1 data • Oncology • Solid Tumor • BRAF • EGFR • KRAS

ERAS-601, a potent allosteric inhibitor of SHP2, synergistically enhances the efficacy of sotorasib/adagrasib and cetuximab in NSCLC, CRC, and HNSCC tumor models (AACR 2022) - P1, P1b/2 | "These nonclinical data support the clinical development of ERAS-601 in combination with a KRASG12C inhibitor in NSCLC and CRC tumors, and ERAS-601 in combination with cetuximab in RAS/RAF wild type CRC as well as HPV-negative HNSCC tumors. Both combinations are being studied in ongoing clinical studies (HERKULES-2, NCT04959981; FLAGSHP-1, NCT04670679)."

Preclinical • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • KRAS • PTPN11

ERAS-601, a potent allosteric inhibitor of SHP2, demonstrates anti-tumor activity in RAS/MAPK-driven tumor models (AACR 2022) - P1 | "ERAS-601 also inhibits tumor growth in multiple RAS/MAPK-driven CDX and PDX models that harbor EGFR, KRAS, BRAF Class III, and NF1LOF mutations. ERAS-601 is a potent and selective allosteric SHP2 inhibitor that demonstrates anti-tumor activity in vitro and in vivo and is currently being studied as a monotherapy in an ongoing Phase 1 clinical study in patients with advanced or metastatic solid tumors (FLAGSHP-1, NCT04670679)."

Preclinical • Oncology • Solid Tumor • BRAF • DUSP6 • EGFR • KRAS • PTPN11

HERKULES-2: A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC (clinicaltrials.gov) - P1b | N=200 | Active, not recruiting | Sponsor: Erasca, Inc. | Recruiting ➔ Active, not recruiting | Phase classification: P1b/2 ➔ P1b

Enrollment closed • Metastases • Phase classification • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Erasca Announces First Patient Dosed in HERKULES-1 Phase 1b Trial Evaluating ERAS-007 and ERAS-601 MAPKlamp Combination in RAS/MAPK Pathway-Altered Solid Tumors (GlobeNewswire) - "Erasca, Inc....announced dosing of the first patient in the HERKULES-1 Phase 1b trial evaluating ERK1/2 inhibitor ERAS-007 in combination with SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in patients with RAS/MAPK pathway-altered solid tumors."

Trial status • Oncology • Solid Tumor

Erasca Reports Third Quarter 2022 Financial Results and Business Updates (GlobeNewswire) - "Key Upcoming Milestones: ERAS-3490: IND filing anticipated in the second half of 2022.... Initiation of a Phase 1b dose escalation trial for ERAS-007 in combination with ERAS-601 (Erasca’s first MAPKlamp approach) anticipated in the first half of 2023, HERKULES-3: Initial Phase 1b combination data anticipated in the first half of 2023, FLAGSHP-1: Phase 1/1b trial for ERAS-601 in patients with advanced solid tumors, Initial Phase 1b combination data in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC anticipated in the first half of 2023....HERKULES-2: Phase 1b/2 trial for ERAS-007 in patients with advanced NSCLC, Initial Phase 1b combination data anticipated in 2023."

IND • P1 data • P1/2 data • Trial status • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Erasca Announces Four Poster Presentations at the Upcoming 34th EORTC-NCI-AACR Symposium (GlobeNewswire) - P1 | N=200 | FLAGSHP-1 (NCT04670679) | Sponsor: Erasca, Inc | "Preliminary Phase 1 data from the ongoing FLAGSHP-1 trial in advanced solid tumors demonstrated promising single agent safety and tolerability and supported the potential of ERAS-601...Well-behaved pharmacokinetic properties enable both twice daily (BID) and daily (QD) dosing; maximum tolerated doses for BID and QD dosing identified. Treatment-related AEs were reversible, manageable, and consistent with the known mechanism of action for the SHP2 inhibitor class. Confirmed partial response in a patient with a BRAF class III mutation was observed following single agent treatment. Preliminary clinical data support continued development in combination with other anti-cancer therapies. Initial Phase 1b data from FLAGSHP-1 in combination with cetuximab in patients with triple wildtype (KRAS/NRAS/BRAF wildtype) CRC are expected in the first half of 2023."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Erasca Presents Promising Preliminary Phase 1/1b Monotherapy Data for ERAS-007 ERK and ERAS-601 SHP2 Inhibitors Supporting Ongoing and Future Combination Trials (GlobeNewswire) - "A retrospective pooled analysis of all trials evaluating ERAS-007 or ERAS-601 in advanced solid tumors was performed that included Erasca’s ongoing HERKULES-1 and FLAGSHP-1 trials and Asana BioSciences’ previously completed ASN007-101 trial....Key findings from the retrospective pooled interim analysis of ERAS-007 and ERAS-601 include: 23% (6/26) of patients with RAS/MAPK-altered non-CRC solid tumors responded (2 confirmed and 4 unconfirmed PRs) to single agent ERAS-007 or ERAS-601; 44% (4/9) with a subset of BRAF-driven non-CRC solid tumors responded (1 confirmed and 3 unconfirmed PRs) to single agent ERAS-007 or ERAS-601."

Retrospective data • Oncology • Solid Tumor

Erasca to Host R&D Day with KOL Dr. David Hong on Lead Clinical Programs ERAS-007 and ERAS-601 in Advanced Solid Tumors (GlobeNewswire) - "Key opinion leader David S. Hong, M.D...who will provide an overview of the current treatment landscape and therapeutic opportunities in cancers driven by the RAS/MAPK pathway and will discuss Erasca’s lead programs in this context."

Live event

Erasca to Host R&D Day with KOL Dr. David Hong on Lead Clinical Programs ERAS-007 and ERAS-601 in Advanced Solid Tumors (GlobeNewswire) - "Erasca, Inc...today announced that it will host a research and development day, with a focus on the company’s ERAS-007 ERK1/2 inhibitor and ERAS-601 SHP2 inhibitor in advanced solid tumors, on Wednesday, September 7, 2022, at 4:30 PM Eastern Time. The virtual event will feature presentations from: Key opinion leader David S. Hong, M.D., of MD Anderson Cancer Center, who will provide an overview of the current treatment landscape and therapeutic opportunities in cancers driven by the RAS/MAPK pathway and will discuss Erasca’s lead programs in this context; Erasca, who will present preliminary clinical data and future directions for its lead clinical candidates with best-in-class potential, ERAS-007 and ERAS-601, for the treatment of advanced solid tumors with RAS/MAPK pathway alterations."

Clinical data • Oncology • Solid Tumor