Results From the PARADIGM Phase 3 Head-to-Head Trial of Vectibix® (panitumumab) Versus Bevacizumab in Untreated RAS Wild-Type Metastatic Colorectal Cancer*
Largest Evaluation of Acquired Resistance to LUMAKRAS®/LUMYKRAS® (sotorasib) in KRAS G12C-mutated Cancers Inform Combination Treatment Approaches
THOUSAND OAKS, Calif., May 26, 2022 /PRNewswire/ — Amgen (NASDAQ:AMGN) will present new data from across its broad oncology innovative medicines and biosimilars portfolio and robust pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 in Chicago and virtually.
Oral presentations will showcase Amgen’s medicines for both lung and colorectal cancers with a plenary session highlighting the results from the PARADIGM Phase 3 head-to-head trial conducted by Takeda Pharmaceutical Company in Japan comparing the efficacy of Vectibix® (panitumumab) versus Avastin® (bevacizumab), both used in combination with chemotherapy, in patients with previously untreated RAS wild-type metastatic colorectal cancer (mCRC)*. Data from a pooled analysis of CodeBreaK 100, representing the largest evaluation of mechanisms of acquired resistance in KRASG12C inhibition, offer new insights to help inform combination treatment approaches with LUMAKRAS®/ LUMYKRAS®.
“Amgen continues to lead the science in KRASG12C inhibition and is committed to advancing research into how LUMAKRAS can improve outcomes for more patients, including further defining resistance patterns to guide our robust combination treatment development program,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “In addition, the compelling head-to-head results further reinforcing the important role Vectibix plays in the treatment of colorectal cancer, illustrate how Amgen is expanding the impact of our first-in-class therapies in some of the most challenging-to-treat cancers.”
In the CodeBreaK 100 analysis, investigators evaluated patterns of resistance to LUMAKRAS in patients with NSCLC (n=67) and CRC (n=45) at disease progression. At least one newly acquired genomic alteration at progression was detected in 19 (28%) NSCLC patients and in 33 (73%) CRC patients. The alterations were heterogeneous in both tumor types, with variants detected across multiple genes and pathways.
Other research highlights being presented on Amgen Oncology’s growing precision medicine and T-cell engager pipeline include study updates on bemarituzumab, a potential first-in-class therapy for a subset of gastric and gastroesophageal cancers that overexpress fibroblast growth factor receptor 2 (FGFR2b), AMG 193, a small molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor being investigated for the treatment of solid tumors, and tarlatamab, an investigational, first-in-class half-life extended (HLE) bispecific T-cell engager (BiTE®) molecule that is uniquely designed to target delta-like ligand 3 (DLL3) in neuroendocrine cancers.
Additional information on Amgen’s abstracts is available on the ASCO website.
Abstracts and Presentation Times:
Amgen Sponsored Abstracts
LUMAKRAS®/LUMYKRAS® (sotorasib)
- Largest evaluation of acquired resistance to sotorasib in KRAS p.G12C-mutated non-small cell lung cancer (NSCLC) and colorectal cancer (CRC): plasma biomarker analysis of CodeBreaK 100
Abstract #102, Oral Presentation Session: Clinical Science Symposium, ctDNA: Dawn of a New Era, Saturday, June 4 from 8:00-9:30 a.m. CDT
- First data for sotorasib in patients with pancreatic cancer with KRAS p.G12C mutation: a phase 1/2 study evaluating efficacy and safety
Abstract #360490, Plenary Series: Rapid Abstract Updates, Sunday, June 5 from 4:30-6:00 p.m. CDT
- Trial-in-progress: A phase 2 study of sotorasib as first-line treatment in patients with stage IV non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS p.G12C mutation (CodeBreaK 201)
Abstract #TPS9150, Poster Presentation Session: Lung Cancer—Non-Small Cell Metastatic, Monday, June 6 from 8:00-11:00 a.m. CDT
IMLYGIC® (talimogene laherparepvec)
- Primary analysis of a phase 2, open-label, multicenter trial of talimogene laherparepvec (T-VEC) plus pembrolizumab (pembro) for the treatment (Tx) of patients (pts) with advanced melanoma (MEL) who progressed on prior anti–PD-1 therapy: MASTERKEY-115
Abstract #9518, Poster Discussion Session: Melanoma/Skin Cancers, Monday, June 6 from 4:30-6:00 p.m. CDT
Investigational BiTE® Platform
- Trial-in-progress: Phase 2 study of tarlatamab, a DLL3-targeting half-life extended bispecific T-cell engager (HLE BiTE®) immuno-oncology therapy, in relapsed/refractory small cell lung cancer (SCLC)
Abstract #TPS8603, Poster Presentation Session: Lung Cancer-Non-small cell local-regional/small cell/other thoracic cancers, Monday, June 6 from 8:00-11:00 a.m. CDT
- Trial-in-progress: A phase 1 study of AMG 509 in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Abstract #TPS5101, Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile, Monday, June 6 from 1:15-4:15 p.m. CDT
AMG 193
- Trial-in-progress: Design and rationale of a phase 1 dose-escalation study of AMG 193, a methylthioadenosine (MTA)-cooperative PRMT5 inhibitor, in patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors
Abstract #TPS3167, Poster Presentation Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology, Sunday, June 5 from 8:00-11:00 a.m. CDT
Bemarituzmab
- Trial-in-progress: Phase 3 study of bemarituzumab + mFOLOFOX6 versus placebo + mFOLFOX6 in previously untreated advanced gastric or gastroesophageal junction (GEJ) cancer with FGFR2b overexpression (FORTITUDE-101)
Abstract #TPS4164, Poster Presentation: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Trial-in-progress: Phase 1b/3 study of bemarituzumab + mFOLFOX6 + nivolumab vs mFOLFOX6 + nivolumab in previously untreated advanced gastric and gastroesophageal junction (GEJ) cancer with FGFR2b overexpression (FORTITUDE-102)
Abstract #TPS4165, Poster Presentation: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary, Saturday, June 4 from 8:00-11:00 a.m. CDT
Partner-Led Abstracts
Vectibix® (panitumumab)
- Plasma RAS dynamics and anti-EGFR rechallenge efficacy in patients with RAS/BRAF wild-type metastatic colorectal cancer: REMARRY and PURSUIT trials
Abstract #3518, Poster Discussion Session: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Resistance mechanisms to anti-EGFR therapy in RAS/RAF wildtype colorectal cancer varies by regimen and line of therapy
Abstract #3554, Poster Presentation: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Panitumumab (PAN) plus mFOLFOX6 versus bevacizumab (BEV) plus mFOLFOX6 as first-line treatment in patients with RAS wild-type metastatic colorectal cancer (mCRC): results from the phase 3 PARADIGM trial
Abstract #LBA1, Plenary Session: Primary Track: Special Sessions, Sunday, June 5 from 1:00-4:00 p.m. CDT
Prolia® (denosumab)
- Long-term outcomes of adjuvant denosumab in breast cancer: Fracture reduction and survival results from 3,425 patients in the randomised, double-blind, placebo-controlled ABCSG-18 trial
Abstract #507, Oral Presentation: Breast Cancer—Local/Regional/Adjuvant, Tuesday, June 7 from 9:45 a.m.-12:45 p.m. CDT
Investigator Sponsored Studies (ISS)
IMLYGIC® (talimogene laherparepvec)
- Trial-in-progress: Neo-adjuvant T-VEC plus nivolumab combination therapy for resectable early- stage or metastatic (IIIB-IVM1a) melanoma with injectable disease: The NIVEC trial
Abstract #TPS9607, Poster Session: Melanoma/Skin Cancers, Monday, June 6 from 1:15-4:15 p.m. CDT
KYPROLIS® (carfilzomib)
- A phase II study of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma
Abstract #8012, Poster Discussion Session: Hematologic Malignancies – Plasma Cell Dyscrasia, Saturday, June 4 from 4:30-6:00 p.m. CDT
- ATLAS: A phase 3 randomized trial of carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma
Abstract #8001, Oral Abstract Session: Hematologic Malignancies—Plasma Cell Dyscrasia, Sunday, June 5 from 8:00-11:00 a.m. CDT
- Daratumumab carfilzomib lenalidomide and dexamethasone as induction therapy in high-risk, transplant-eligible patients with newly diagnosed myeloma: Results of the phase 2 study IFM 2018-04
Abstract #8002, Oral Abstract Session: Hematologic Malignancies—Plasma Cell Dyscrasia, Sunday, June 5 from 8:00-11:00 a.m. CDT
LUMAKRAS®/LUMYKRAS® (sotorasib)
- Trial-in-progress: A phase Ib/II study of sotorasib combined with chemotherapy for second-line treatment of KRAS p. G12C mutated advanced pancreatic cancer
Abstract #TPS4194, Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Predictors of biomarker testing among patients (pts) with metastatic non-small cell lung cancer (mNSCLC)
Abstract #9130, Poster Session: Lung Cancer—Non-Small Cell Metastatic, Monday, June 6 from 8:00-11:00 a.m. CDT
Vectibix® (panitumumab)
- Phase 2 study of anti-EGFR rechallenge therapy with panitumumab with or without trametinib in advanced colorectal cancer
Abstract #3520, Poster Discussion Session: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Negative hyperselection for mutations associated with anti-EGFR antibody resistance in RAS wildtype metastatic colorectal cancer (mCRC): Evaluation of the PANAMA trial (AIO-KRK-0212, maintenance therapy with 5-FU, folinic acid (FU/FA) with or without panitumumab)
Abstract #3536, Poster Session: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Consensus molecular subtypes (CMS) as prognostic & predictive biomarkers of panitumumab (Pmab), fluorouracil & folinic acid (FU/FA) or FU/FA maintenance therapy following Pmab-FOLFOX induction in RAS wildtype metastatic colorectal cancer (mCRC) – PANAMA trial (AIO-KRK-0212)
Abstract #3537, Poster Session: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Impact of age and gender on the efficacy & safety of panitumumab plus fluorouracil & folinic acid versus fluorouracil and folinic acid alone as maintenance therapy in RAS WT metastatic colorectal cancer (mCRC). Subgroup analysis of the PANAMA-study (AIO-KRK-0212)
Abstract #3567, Poster Session: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Predictive and prognostic value of carcinoembryonic antigen (CEA) on maintenance therapy with 5-fluoruracil/leucovorin plus panitumumab or 5-fluoruracil/leucovorin alone in RAS wildtype metastatic colorectal cancer: Evaluation of the phase II PanaMa trial (AIO KRK 0212)
Abstract # 3587, Poster Session: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 8:00-11:00 a.m. CDT
- Modified FOLFOXIRI plus panitumumab (mFOLFOXIRI/PAN) versus mFOLFOX6/PAN as initial treatment of unresectable RAS and BRAF wild-type metastatic colorectal cancer (mCRC) patients: results of the phase III randomized TRIPLETE study by GONO
Abstract #LBA3505, Oral Presentation: Gastrointestinal Cancer—Colorectal and Anal, Saturday, June 4 from 9:45 a.m.–12:45 p.m. CDT
- Randomized intermittent or continuous panitumumab plus FOLFIRI (FOLFIRI/PANI) for first-line treatment of patients (pts) with RAS/BRAF wild-type metastatic colorectal cancer (mCRC): the IMPROVE study
Abstract #3503, Oral Abstract Session: Gastrointestinal Cancer—Colorectal and Anal, Monday, June 6 from 9:45 a.m.-12:45 p.m. CDT
XGEVA® (denosumab)
- Trial-in-progress: A phase 3 study to determine the breast cancer risk reducing effect of denosumab in women carrying a germline BRCA1 mutation (BRCA-P Study)
Abstract #TPS10616, Poster Session: Prevention, Risk Reduction, and Hereditary Cancer, Monday, June 6 from 1:15-4:15 p.m. CDT
*Amgen out licenses Vectibix to Takeda in Japan.
