ALIMTA SUMMARY
ALIMTA® , pemetrexed for injection, is an antifolate antineoplastic agent that exerts its action by disrupting folate-dependent metabolic processes essential for cell replication. Pemetrexed disodium heptahydrate has the chemical name L-Glutamic acid,
N
-[4-[2-(2-amino-4,7-dihydro-4-oxo-1
H
-pyrrolo[2,3-
d
]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate.
Mesothelioma: ALIMTA in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
Non-Small Cell Lung Cancer: ALIMTA as a single-agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.
The effectiveness of ALIMTA in second-line NSCLC was based on the surrogate endpoint, response rate. There are no controlled trials demonstrating a clinical benefit, such as a favorable survival effect or improvement of disease-related symptoms.
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NEWS HIGHLIGHTS
Published Studies Related to Alimta (Pemetrexed)
Comparison of pemetrexed plus cisplatin with other first-line doublets in advanced non-small cell lung cancer (NSCLC): A combined analysis of three phase 3 trials. [2011.11.22]
INTRODUCTION: In a first-line study of advanced NSCLC, pemetrexed-cisplatin was more effective among patients with adenocarcinoma and large-cell carcinoma compared with gemcitabine-cisplatin (median survival of 11.8 versus 10.4 months, P=.005), while survival with pemetrexed-cisplatin was shorter than with gemcitabine-cisplatin in patients with squamous cell carcinoma. The comparability of pemetrexed-cisplatin to other commonly used regimens within histology subgroups needs to be explored... CONCLUSION: In the absence of randomized clinical trial data comparing pemetrexed-cisplatin to commonly used doublets in advanced NSCLC other than gemcitabine-cisplatin, this combined analysis of multiple trials provides estimates for such comparisons. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
Randomized phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B trial 30407. [2011.08.10]
PURPOSE: Cancer and Leukemia Group B conducted a randomized phase II trial to investigate two novel chemotherapy regimens in combination with concurrent thoracic radiation therapy (TRT)... CONCLUSION: The combination of pemetrexed, carboplatin, and TRT met the prespecified criteria for further evaluation. This regimen should be studied further in patients with locally advanced unresectable nonsquamous NSCLC.
Comparative effectiveness of bevacizumab plus cisplatin-based chemotherapy versus pemetrexed plus cisplatin treatment in East Asian non-squamous non-small cell lung cancer patients applying real-life outcomes. [2011.06]
AIM: To indirectly compare real-life clinical effectiveness of bevacizumab + cisplatin-based therapy from the Safety of Avastin in Lung (SAiL) phase IV clinical trial with published evidence from the phase III clinical trial for pemetrexed + cisplatin among East Asian patients with non-squamous metastatic or recurrent non-small cell lung cancer (NSCLC)... CONCLUSION: The results suggest that East Asian non-squamous NSCLC patients treated with bevacizumab-based therapy have a trend toward improved PFS outcomes compared to those treated with pemetrexed + cisplatin, even after adjusting for differences between the two trial groups. (c) 2011 Blackwell Publishing Asia Pty Ltd.
An indirect comparison of bevacizumab plus cisplatin-gemcitabine and cisplatin plus pemetrexed treatment for patients with advanced first-line non-squamous non-small cell lung cancer in East Asia. [2011.06]
AIMS: To compare the relative efficacy of bevacizumab plus cisplatin-gemcitabine chemotherapy (BevCG) with cisplatin plus pemetrexed (CP) in the first-line treatment of advanced or recurrent non-small cell lung cancer (NSCLC) in East Asian patients. In the absence of evidence from head-to-head trials, an adjusted indirect treatment comparison (ITC) approach was selected to compare these treatments... CONCLUSION: BevCG can be considered a more effective therapy than CP for NSCLC patients in East Asia. (c) 2011 Blackwell Publishing Asia Pty Ltd.
A phase II, randomized, multicenter study to assess the efficacy, safety, and tolerability of zibotentan (ZD4054) in combination with pemetrexed in patients with advanced non-small cell lung cancer. [2011.05]
PURPOSE: This study evaluated overall survival (OS) of patients with advanced non-squamous NSCLC following treatment with the specific endothelin A receptor antagonist, zibotentan in combination with pemetrexed compared with pemetrexed monotherapy... CONCLUSIONS: There was no survival signal in patients with NSCLC following treatment with zibotentan in combination with pemetrexed. No new issues related to safety for either zibotentan or pemetrexed were identified.
Clinical Trials Related to Alimta (Pemetrexed)
Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients [Active, not recruiting]
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop
them from dividing, or stop the growth of the blood supply that cancers need to grow and
spread. Clinical research has shown that drugs that inhibit vascular endothelial growth
factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase
overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical
studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR
signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking
their blood supply and by stopping them from dividing. This lung cancer study is to
investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta
(pemetrexed) alone.
Study of AlimtaŽ (Pemetrexed) Plus VELCADEŽ (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy [Completed]
The purpose of this study is to establish the objective response rate (complete response +
partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE
alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who
have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment
group will be used as the control. The VELCADE single-agent treatment group will be used to
determine if VELCADE administered weekly can demonstrate response rates.
ZD6474(Vandetanib) + Alimta Combo Study [Active, not recruiting]
The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets)
to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help
control their symptoms and disease better than the chemotherapy alone.
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas. [Completed]
Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA
for the treatment of cancer of the pancreas. Patients may be able to participate in this
study if they have cancer in their pancreas that cannot be removed by surgery OR that has
spread to a new site in their body.
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer [Completed]
To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed
for the treatment of patients with locally advanced or metastatic NSCLC who have failed one
prior chemotherapy regimen
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