ABP 234 vs Keytruda for Lung Cancer

Recruiting at 314 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Cytotoxic chemotherapy, Immunotherapy

Disqualifiers: Small cell lung cancer, CNS metastases, Immune-mediated disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 49 weeks

927 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new lung cancer treatment, ABP 234 (a pembrolizumab biosimilar), against the existing treatment Keytruda (pembrolizumab). The researchers aim to compare the effectiveness of ABP 234 to Keytruda in individuals with advanced non-squamous Non-Small Cell Lung Cancer. Participants will receive either ABP 234 or Keytruda, followed by chemotherapy. Those diagnosed with stage IV non-squamous Non-Small Cell Lung Cancer who have not previously received treatment for this advanced stage may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had prior systemic treatment for advanced disease.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research examines how ABP 234 and Keytruda (pembrolizumab) compare in treating lung cancer. Keytruda, already approved for various conditions, has a well-understood safety profile. Most people tolerate Keytruda well, though some may experience fatigue or nausea.

For ABP 234, ongoing studies aim to confirm its safety and effectiveness. Since this trial is in an advanced stage, earlier tests indicated it is likely safe for humans. However, every new treatment carries risks. Researchers closely monitor participants for any side effects or unexpected issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABP 234 because it represents a new approach to treating lung cancer. Unlike standard treatments, which often rely on existing drugs like pembrolizumab, ABP 234 potentially offers a novel mechanism of action that could enhance effectiveness. This new angle might improve how well patients respond to chemotherapy, making it a promising option in the fight against lung cancer.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research shows that pembrolizumab, also known as Keytruda, effectively treats lung cancer. Studies have consistently found that it can help control cancer growth and improve survival rates. In this trial, some participants will receive pembrolizumab, while others will receive ABP 234, a biosimilar designed to mimic pembrolizumab. Early research suggests that ABP 234 acts similarly to pembrolizumab and shares a similar safety profile. This trial will compare both treatments to determine if ABP 234 is as effective as pembrolizumab. ^{1 2 3 4 6}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults with stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic treatment for advanced disease. They should be relatively healthy, able to perform daily activities (ECOG score 0 or 1), and not have certain gene mutations (EGFR, ALK, ROS-1 negative). Participants must also have a life expectancy of at least 3 months and available tumor tissue for testing.

Inclusion Criteria

My lung cancer is advanced and not squamous type.

I have not received any systemic treatment for my advanced disease.

My doctor expects me to live at least 3 more months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab or ABP 234 followed by pemetrexed with or without platinum-based chemotherapy

49 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABP 234
• Pembrolizumab

Trial Overview The study aims to compare the effectiveness of ABP 234 with Keytruda® (pembrolizumab), which are both treatments for lung cancer. Patients will receive either ABP 234 or pembrolizumab to see how well they work in treating their cancer.

How Is the Trial Designed?

Group I: Pembrolizumab (US) Experimental Treatment 1 Intervention

Part 1: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed.

Group II: Pembrolizumab (EU) Experimental Treatment 1 Intervention

Part 1: Participants will receive EU-approved pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive EU-approved pembrolizumab followed by pemetrexed.

Group III: ABP 234 Experimental Treatment 1 Intervention

Part 1: Participants will receive ABP 234 followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive ABP 234 followed by pemetrexed.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.

The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. Zapata, E., Mennecier, B., Leduc, C., et al.[2017]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating unresectable or metastatic melanoma based on two clinical trials involving 1,374 patients, showing significant improvements in overall survival compared to ipilimumab, with hazard ratios indicating a reduced risk of death.

Patients receiving pembrolizumab also experienced significant improvements in progression-free survival, although some immune-mediated adverse reactions like hypothyroidism and pneumonitis were noted, highlighting the importance of monitoring for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. Barone, A., Hazarika, M., Theoret, MR., et al.[2022]

In a study of 411 patients with non-small cell lung cancer (NSCLC), 33% showed no PD-L1 expression, 38% had low expression, and 29% exhibited high expression, indicating a significant variability in PD-L1 status among patients.

The study found that PD-L1 positivity was linked to factors such as male sex, smoking history, higher tumor grade, and specific histologic types, suggesting that these characteristics may influence the effectiveness of pembrolizumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Death-ligand 1 Expression With Clone 22C3 in Non-small Cell Lung Cancer: A Single Institution Experience. Takeda, M., Kasai, T., Naito, M., et al.[2022]

Pembrolizumab, an immune checkpoint inhibitor, can cause pneumonitis in 1%-5% of patients, and this case report highlights an atypical presentation of this side effect in a patient with metastatic squamous cell carcinoma.

The patient was successfully treated with steroid therapy after ruling out other potential causes, leading to complete resolution of the pneumonitis, emphasizing the importance of recognizing and managing atypical cases of checkpoint inhibitor-pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. Jeon, WJ., Nguyen, J., Castillo, DR., et al.[2023]

In a study involving 1,453 patients with advanced melanoma and non-small cell lung cancer (NSCLC), pembrolizumab showed no dependency on dosage for overall survival, indicating that varying doses (2 to 10 mg/kg) did not significantly affect patient outcomes.

A strong association was found between the baseline clearance (CL0) of pembrolizumab and overall survival, suggesting that higher clearance rates may indicate more severe disease, rather than affecting the drug's efficacy directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Exposure-Response Assessments Challenged by Association of Cancer Cachexia and Catabolic Clearance. Turner, DC., Kondic, AG., Anderson, KM., et al.[2019]

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06311721

NCT06311721 | A Study to Compare ABP 234 and ... A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects ...

2. amgentrials.com amgentrials.com/study/?id=20210033

AMGEN - A Study to Compare ABP 234 and Keytruda ... The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).

3. registry.healthresearch.ph registry.healthresearch.ph/index.php/registry?view=research&layout=details&cid=7717

A Randomized, Double-Blind Study to Compare Efficacy, ... A randomized, double-blind study to compare efficacy, pharmacokinetics, safety, and immunogenicity between ABP 234 and Keytruda® (Pembrolizumab)

4. nycancer.com nycancer.com/trials/Amgen_MARIGOLD

MARIGOLD: A Study to Compare ABP 234 and Keytruda ... A randomized, double-blind study to compare efficacy, pharmacokinetics, safety, and immunogenicity between ABP 234 and Keytruda® (Pembrolizumab)

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/33514992/amgens-new-study-on-abp-234-a-potential-game-changer-in-lung-cancer-treatment/

Amgen's New Study on ABP 234: A Potential Game ... The study aims to demonstrate the pharmacokinetic similarity between ABP 234, a biosimilar, and the established drug Pembrolizumab.

6. synapse.patsnap.com synapse.patsnap.com/drug/582572bdbaad41e8ade5d14ad3094e4c

Pembrolizumab Biosimilar(Amgen) - Drug Targets, ... A randomized, double-blind study to compare the pharmacokinetics between ABP 234 and Keytruda® (Pembrolizumab) in participants with early-stage non-squamous ...