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New Data Support Gefitinib (Iressa, ZD1839) As Efficacious Anti-Cancer Agent In Non-Small Cell Lung Cancer: Presented at WCLC

VANCOUVER, BC -- August 14, 2003 -- New data add to the growing evidence of gefitinib's (IRESSA™ ZD1839) efficacy and well-established safety profile and reinforce its current and future role as a leading targeted treatment in the fight against non-small cell lung cancer (NSCLC). Data from the Phase ll IDEAL studies (1) reveal patients with advanced NSCLC, all with a very poor prognosis, reported an average tumour reduction of >80% when taking gefitinib.

Disease responses were rapid, with many patients achieving a >50% reduction in their tumour (defined as a 'partial response') by week four of treatment and by week 12, 90% of responding patients (who received 250mg gefitinib each day) had achieved a partial response. Furthermore, encouraging preliminary data (2) also suggest gefitinib has promising activity in patients with bronchioloalveolar cell carcinoma (BAC), a NSCLC subtype that is increasing in incidence but is considered difficult to treat as it does not respond well to standard chemotherapy treatments. These promising new data presented at the World Conference on Lung Cancer today reinforce gefitinib's clinical benefit and provide hope to the thousands of patients and their families affected by this devastating disease.

Dr George Blackledge, Medical Director of Oncology at AstraZeneca commented: "Gefitinib has given hope to more than 80,000 patients with advanced NSCLC who previously had no other treatment option available to them. It is very assuring for both clinicians and patients, that these new data provide further clinical evidence supporting gefitinib's efficacy and tolerability and its benefit to patients. AstraZeneca is committed to further scientific understanding of the biochemical and molecular processes, which may determine optimal response to gefitinib and ultimately improve patient care. We feel very encouraged that these clinical trials support our ongoing clinical development programme for gefitinib."

Encouraging clinical benefit findings in a range of patient types
New findings from the IDEAL 1 and 2 studies (1) demonstrate that gefitinib provides clinically meaningful, rapid and durable antitumour activity in some patients with refractory NSCLC. In patients whose tumours shrank due to gefitinib treatment, average tumour shrinkage from both trials and doses (250mg/d and 500mg/d) was >80% with more than 70% of patients experiencing partial response by week four. More than 40 per cent of patients gained life-enhancing benefit (tumour shrinkage + stabilised disease, associated with symptom relief) from treatment with gefitinib. (3) Furthermore, the IDEAL results demonstrate that responses to gefitinib are long-lasting, as approximately 30% of patients, all of whom had a very poor prognosis, were alive one year after starting treatment. (3)

A promising new study (2) investigated the role of gefitinib 500mg per day as monotherapy in treating patients with BAC. The response rate of BAC to conventional chemotherapy is generally considered to be low and the increasing incidence of BAC highlights the need for alternative, effective treatment options. The preliminary results of the study revealed patients achieved both complete and partial responses and that gefitinib was generally well tolerated.

Data from patients who received gefitinib as monotherapy on a compassionate use basis, also revealed positive antitumour activity and clinical benefits of gefitinib:

- In a series of advanced NSCLC patients who had previously received standard chemotherapy and had a very poor prognosis, 14 out of 50 (28%) patients experienced a partial response and a further 3 patients experienced stable disease when taking gefitinib. Responses to gefitinib were long-lasting with 34 (68%) patients alive after 150 days. These results indicate that gefitinib provides antitumour activity and clinical benefits, especially in patients with a performance status of 0-2. (4)

- In a series of patients with advanced recurrent NSCLC, patients received gefitinib as a last option. Of the 92 patients, the majority of whom had 2 or more previous chemotherapy regimens, 1 patient achieved a complete response and 7 achieved partial response. Disease stabilisation was reported in 34 (37%) patients and 21 (22%) patients reported symptom improvements. Of the 24 patients that received radiotherapy, no extra toxicity was observed. The data series further supports gefitinib's monotherapy efficacy. (5)

Data in brain metastases
A retrospective analysis by Chiu et al of lung cancer patients who had developed metastatic disease in the brain showed that gefitinib has an active anti-tumour effect on the brain metastases. (6) Partial responses and stable disease were observed in patients who had only received gefitinib treatment after their lung cancer had spread to the brain. These results are intriguing as the treatment of brain metastases is a major clinical challenge for physicians treating lung cancer patients; as a result of this analysis Chiu et al recommend prospective studies are undertaken to determine the effect of gefitinib in this set of patients.

Supporting tolerability and safety
As shown by the IDEAL studies, 250mg/day can produce unprecedented activity in patients with NSCLC, while at the same time maintaining its favourable tolerability profile with most common reported side effects being skin rash and diarrhoea. Treatment with gefitinib is not typically associated with the adverse events of standard chemotherapy, such as myelosuppression, neuropathy, neutropenia or other haemetological toxicities. (3) The safety profile of 250mg/day gefitinib, combined with efficacy data, demonstrates an extremely favourable risk:benefit balance in the area of high unmet need where no proven effective therapy exists. (7)

About gefitinib
Gefitinib is the first in a novel, new class of anti-cancer drugs known as Epidermal Growth Factor Receptor (EGFR) - Tyrosine Kinase (EGFR-TK) inhibitors. It is administered as a once-daily, oral tablet. Gefitinib has been approved for the treatment of advanced NSCLC in the US, Australia, Japan, Argentina, Singapore and Korea and is currently undergoing regulatory review with several other regulatory authorities worldwide. AstraZeneca is committed to further investigating the potential for this novel treatment in multiple tumour and disease settings.

References:

1.Fukuoka M et al. Phase ll trials of gefitinib ('Iressa', ZD1839): rapid and durable objective responses in patients with advanced non-small-cell lung cancer (IDEAL 1 and IDEAL 2). World Conference on Lung Cancer, Vancouver, Canada 10-14 August 2003. P-615. Thursday 14 August

2.West H.L. et al. ZD1839 (Iressa) in Advanced Bronchioloalveolar Carcinoma (BAC): A Preliminary Report of SWOG S0126. World Conference on Lung Cancer, Vancouver, Canada 10-14 August 2003. Oral Presentation 13:30hrs, O-187, Wednesday 13 August

3.Fukuoka M et al. A multi-institutional randomized phase II trial of ZD1839 ('Iressa') for previously treated patients with advanced Non-Small Cell Lung Cancer (IDEAL 1 Trial). Journal of Clinical Oncology 2003; 21 (12): 2237-2246

4.Park J et al. Gefitinib ('Iressa, ZD1839) monotherapy as a salvage regimen for previously treated advanced non-small-cell lung cancer (NSCLC). World Conference on Lung Cancer, Vancouver, Canada 10-14 August 2003. P-620. Thursday 14 August

5.Haringhuizen A et al. Gefitinib (ZD1839, Iressa) as a last option for patients with recurrent non-small-cell lung cancer (NSCLC). World Conference on Lung Cancer, Vancouver, Canada 10-14 August 2003. P-617. Thursday 14 August

6.Chiu, C-H et al. Effect of ZD1839 (IRESSA) on metastatic brain lesions in patients with advanced non-small cell lung cancer. World Conference on Lung Cancer, Vancouver, Canada 10-14 August 2003. P-631. Thursday 14 August

7.Forsythe B et al. Clinical experience with gefitinib ('Iressa', ZD1839): an overview of safety and tolerability. World Conference on Lung Cancer, Vancouver, Canada 10-14 August. Oral Presentation 10:15hrs, O-240, Thursday 14 August


SOURCE: Shire Health International

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