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ESMO 2023

Amgen to Present New Research from Oncology Portfolio and Pipeline at ESMO 2023

  • Results From Phase 2 DeLLphi-301 Trial Highlight Potential of Tarlatamab, First BiTE in Patients With Previously Treated SCLC
  • Pivotal Phase 3 CodeBreaK 300 Study Data Support LUMAKRAS® (sotorasib) Plus Vectibix® (panitumumab) Combination in KRAS G12C-Mutated mCRC
  • Early-Stage Results for AMG 509 (xaluritamig) Illustrate Expanding Potential of Amgen's T-Cell Engagers in mCRPC

Reno, Nevada (UroToday.com) -- Amgen (NASDAQ:AMGN) announced the presentation of new data across its broad oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2023, taking place from October 20-24 in Madrid. Results from Amgen-sponsored and collaborative studies, including two late-breaking oral presentations, will feature data in a range of tough-to-treat cancers.

"Our data at ESMO demonstrate the rapid progress we are making in advancing a portfolio with first-in-class therapies, including metastatic KRAS G12C mutated colorectal cancer and small cell lung cancer," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These findings illustrate how we are attacking cancer from many different angles to deliver new approaches poised to alter the natural history of disease across many cancers."
Amgen will present data from two late-breaking abstracts at ESMO:

Results from CodeBreaK 300 (Abstract #LBA10), a global, registration-enabling Phase 3 trial evaluating LUMAKRAS (sotorasib) combined with Vectibix (panitumumab) in chemorefractory KRAS G12C-mutated metastatic CRC. These data will be featured as a Presidential Symposium Oral Presentation on Sunday, October 22.

Results from DeLLphi-301 (Abstract #LBA92), a global, potentially registration-enabling Phase 2 trial evaluating tarlatamab, a first-in-class DLL3 targeting bispecific T-cell engager (BiTE®) molecule, in patients with SCLC who had failed two or more prior lines of treatment. These data will be presented in a Proffered Paper Oral Session on Friday, October 20.

Interim results from a Phase 1 study of AMG 509 (xaluritamig) will be presented during a Proffered Paper Oral Session (Abstract #1765O), demonstrating that the novel bispecific STEAP1 x CD3 XmAb® 2+1 T-cell engager had a positive benefit/risk profile with robust anti-tumor activity in heavily pretreated patients with mCRPC (N=97). Overall, of the 67 RECIST-evaluable patients, 16 (24%) had confirmed partial responses (PR) and 32 (48%) had stable disease (SD), demonstrating encouraging preliminary efficacy. At higher dosing levels (n=37), 15 patients (41%) had confirmed PR and 14 (38%) with SD. The most common treatment-related adverse events were cytokine release syndrome (CRS; 72%; primarily low grade), fatigue (45%), myalgia (34%) and pyrexia (32%).

These results further justify exploration of this modality as a potential therapy for prostate cancer. Dose expansion and optimization are currently ongoing.

For more information on the Amgen abstracts, see below.

Abstracts and Presentation Times:

Amgen Sponsored Abstracts

LUMAKRAS®/LUMYKRAS® (sotorasib) + VECTIBIX® (panitumumab) for CRC

  • Sotorasib plus panitumumab versus standard-of-care for chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC): CodeBreaK 300 phase 3 study. Abstract #LBA10, Proffered Paper Oral Session: Presidential 2, Madrid Auditorium - Hall 6, Sunday, October 22 from 5:50 - 6:02 p.m. CEST
Tarlatamab

  • Tarlatamab for patients (pts) with previously treated small cell lung cancer (SCLC): Primary analysis of the phase 2 DeLLphi-301 study. Abstract #LBA92, Proffered Paper Oral Session: Non metastatic NSCLC and other thoracic malignancies, Sevilla Auditorium - Hall 9, Friday, October 20 from 3:20 – 3:30 p.m. CEST
AMG 509 (xaluritamig)

  • Interim Results From a Phase 1 Study of AMG 509 (xaluritamig), a STEAP1 x CD3 XmAb® 2+1 Immune Therapy, in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC). Abstract #1765O, Proffered Paper Oral Session: Genitourinary tumours, prostate, Granada Auditorium - Hall 3, Friday, October 20 from 4:10 - 4:20 p.m. CEST
Bemarituzumab

  • Phase 1b Results of Bemarituzumab (BEMA)+mFOLFOX6+Nivolumab (NIVO) for Advanced Gastric/Gastroesophageal Junction Cancer (G/GEJC): FORTITUDE-102 Part 1. Abstract #1526P, Onsite Poster, Monday, October 23
LUMAKRAS®/LUMYKRAS® (sotorasib) for Non-Small Cell Lung Cancer (NSCLC)

  • Real-world routine KRAS testing practices in France for patients (pts) with advanced or metastatic (AM) Non-Small Cell Lung Cancer (NSCLC): data from the ESME cohort. Abstract #1402P, Onsite Poster, Monday, October 23.
  • Clinical characteristics and therapeutics sequences of KRAS G12C metastatic Non-Small Cell Lung Cancer (mNSCLC) patients treated by sotorasib in the French pre-marketing authorization (MA) early access program (cohort temporary authorization of use, cATU). Abstract #1404P, Onsite Poster, Monday, October 23
  • Characteristics and treatment sequences of patients (pts) with KRAS G12C, other KRAS and non-KRAS advanced or metastatic (AM) Non-Small Cell Lung Cancer (NSCLC) in the French ESME cohort. Abstract #1407P, Onsite Poster, Monday, October 23
  • Characterization of patients with advanced non-small-cell lung cancer (NSCLC) harboring KRASG12C mutation and their associated direct healthcare costs in Spanish routine clinical practice (SILK study). Abstract #1410P, Onsite Poster, Monday, October 23

Investigator Sponsored Studies

VECTIBIX® (panitumumab)

  • Panitumumab (P) + FOLFIRINOX or mFOLFOX6 in unresectable metastatic colorectal cancer (mCRC) patients (pts) with RAS/BRAF wild-type (WT) tumor status from circulating DNA (cirDNA). First results of the randomised phase II PANIRINOX-UCGI28 study. Abstract #LBA30, Mini oral session: Gastrointestinal tumours, lower digestive, Sunday, October 22 from 2:45 – 2:50 p.m. CEST
  • FOxTROT: results of embedded phase II evaluating the addition of panitumumab (pan) to neo-adjuvant FOLFOX for patients (pts) with KRAS-wt colon cancer (CC) with extended biomarker panel. Abstract #552O, Proffered Paper Oral Session 2: Gastrointestinal tumours, lower digestive, Barcelona Auditorium - Hall 9, Monday, October 23 from 8:30 – 8:40 a.m. CEST
  • Evaluation of the metastatic colorectal cancer score (mCCS) in predicting outcome for patients with RAS wild type metastatic colorectal cancer (mCRC) treated with first-line (1L) panitumumab (PAN) plus FOLFIRI/FOLFOX: Updated interim results of the non-interventional study VALIDATE. Abstract #622P, Onsite Poster, Sunday, October 22

XGEVA® (denosumab)

  • Results of the window-of-opportunity clinical trial D-BIOMARK: Study of biomarkers of the antitumor activity of denosumab and its role as a modulator of the immune response in early breast cancer. Abstract #289P, Onsite Poster, Saturday, October 21
  • Pembrolizumab and Denosumab in clear cell renal cell carcinoma (ccRCC): a phase 2 trial (KeyPAD, ANZUP1601). Abstract #1886P, Onsite Poster, Monday, October 23

Source: Amgen. (2023). Amgen to Present New Research from Oncology Portfolio and Pipeline at ESMO 2023 [Press release]. https://www.amgen.com/newsroom/press-releases/2023/10/amgen-to-present-new-research-from-oncology-portfolio-and-pipeline-at-esmo-2023.