marked.bio

anti-VEGFR2 antibody · antibody

ramucirumab

9 active trials across 10 of our biomarkers, targeting VEGFR2. 2 active approvals for a biomarker on marked.bio.

Also known as IMC-1121B, Cyramza.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
ramucirumab with erlotinib
FDA, 2020
first line, metastatic, EGFR exon 19 deletion or exon 21 L858R Label 1.2: with erlotinib, first-line metastatic NSCLC with ex19del or L858R. Year confirmed: FDA approval announced 29/05/2020. Source
EU (EMA), 2020
first line, metastatic with activating EGFR mutations II/0033, EC decision 23/01/2020. The EPAR web page indication list omits this NSCLC bullet; date and wording taken from the procedural-steps document. Source
Cyramzaerlotinib page 		EGFR exon 19 deletion / L858R NSCLC Approved 2020 Approved 2020

RELAY vs placebo + erlotinib, 224 vs 225 patients
PFS 19.4 months vs 12.4 months, HR 0.59 (0.46-0.76)Response 76% vs 75%OS 51.1 months vs 46.0 months, HR 0.98 (0.78-1.24), not significant

Stopped for side effects 13% (all study drugs)

Trial details and side effects
Patients
first-line EGFR exon 19 deletion or L858R NSCLC (NCT02411448)
Most common side effects
infections 81%, diarrhoea 70%, hypertension 45%, stomatitis 42%, proteinuria 34%, alopecia 34%, epistaxis 34% (221 patients)
Notes
Ramucirumab with erlotinib. US label rev. 08/2025.
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 3 5 Phase 3
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 2 Phase 1/2
ALK fusion 1 1 Phase 1/2
Claudin 18.2 expression 1 1 Phase 3
KRAS G12C 1 1 Phase 1
KRAS G12D 1 1 Phase 1
MET exon 14 skipping 1 1 Phase 2
FGFR2 fusion or rearrangement 0 1 –
FGFR3 alteration (mutation or fusion) 0 1 –
MSI-H / dMMR 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of ramucirumab.

  1. Eli Lilly 1
  2. Taiho Pharmaceutical 1
  3. Pieris Pharmaceuticals 1
  4. AstraZeneca 1

Trials

9 of 13 trials shown

  1. AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

    Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2026-05 NCT06346392

    AZD0901ramucirumabpaclitaxeldocetaxelirinotecantrifluridine/tipiracilapatinib

    (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer

  2. A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

    Active, not recruiting Phase 3 Eli Lilly Started 2015Primary completion 2019-01 NCT02411448

    ramucirumab FDA EUerlotinib FDA EUgefitinib FDA EUosimertinib FDA EU

    …h erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].

    EGFR exon 19 deletion / L858RMetastatic Non-Small Cell Lung Cancer

  3. Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

    Recruiting Phase 2 SWOG Cancer Research Network Started 2024Primary completion 2028-05 NCT06031688

    ramucirumabtepotinib FDA EU

    Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA \[ctDN…

    MET exon 14 skippingRecurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

  4. T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

    Recruiting Phase 1/2 Yonsei University Started 2024Primary completion 2025-12 NCT05894824

    trastuzumab deruxtecan FDA EUramucirumab

    Histologically or cytologically proven metastatic or locally advanced HER2 low gastric or GEJ adenocarcinoma: The definition of HER2 low is 1+ by immunohistochemistry (…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Gastric Cancer, Gastroesophageal Junction (GEJ) Cancer

  5. Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

    Recruiting Phase 2 SWOG Cancer Research Network Started 2023Primary completion 2027-06 NCT05642572

    capmatinibosimertinib FDA EUramucirumab FDA EU

    Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physicia…

    EGFR exon 19 deletion / L858RRecurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

  6. A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer

    Active, not recruiting Phase 1/2 Memorial Sloan Kettering Cancer Center Started 2023Primary completion 2028-08 NCT06007937

    lorlatinib FDA EUramucirumab

    ALK fusion identified by next generation sequencing (NGS) or IHC on material obtained from tumor or …

    ALK fusionNon Small Cell Lung Cancer, Metastatic, Recurrent

  7. Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

    Active, not recruiting Phase 2 Pieris Pharmaceuticals Started 2021Primary completion 2023-02 NCT05190445

    ramucirumabpaclitaxeltucatinib

    …aclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2022-09-08HER2-positive Gastric Cancer

  8. Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 2 Xiuning Le Started 2019Primary completion 2026-12 NCT03909334

    osimertinib FDA EUramucirumab FDA EU

    NSCLC which harbours EGFR Exon 19 deletion.

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer, EGFR Gene Mutation, Advanced Cancer, Metastatic Cancer

  9. AB122 Platform Study

    Recruiting Phase 1 Taiho Pharmaceutical Started 2021Primary completion 2027-06 NCT04999761

    zimberelimabTAS-116futibatinibTAS-115trifluridine/tipiracilramucirumabbevacizumabfluorouracilcisplatinAB154carboplatinnab-paclitaxel

    …ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\].

    KRAS G12CKRAS G12DAdvanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer