cancer

cancer / company news / competitive intelligence / lung cancer / market intelligence / market trends / oncology — Comments Off
2
Jun 08

Erbitux extends overall survival by 5 weeks in lung cancer


ImClone announced that late-stage study data showed that first-line treatment with Erbitux (cetuximab) plus standard chemotherapy significantly increased overall survival by about five weeks in patients with advanced non-small cell lung cancer (NSCLC), compared with chemotherapy alone. The results were presented at the American Society of Clinical Oncology (ASCO) meeting this weekend.

To put things in context, the American Cancer Society estimates that in the United States, more than 215,000 people will be diagnosed with lung cancer in 2008, which accounts for about 15 percent of all cancer diagnoses. Approximately 87 percent of these patients will be diagnosed with NSCLC, with many being diagnosed with locally advanced or metastatic disease. Lung cancer is the leading cause of cancer-related death in men and women, with more than 161,000 deaths expected to occur in 2008 – accounting for about 29 percent of all cancer deaths. In 2008, it is estimated that more Americans will die from lung cancer than breast, prostate, and colorectal cancers combined. Studies showing a significant improvement in survival will therefore impact the course of disease and affect large numbers of patients.

The randomised FLEX study involved 1125 patients with advanced non-small cell lung cancer (NSCLC) who had not previously received chemotherapy. The data demonstrated that those who received ImClone announced that Erbitux combined with chemotherapy resulted in a median overall survival of 11.3 months, compared with 10.1 months for chemotherapy alone, a significant difference. The findings also showed that tumours shrank in 36.3 percent of patients who received the Erbitux regimen, compared with 29.2 percent of patients who only received standard chemotherapy.

It is unlikely that the findings are impressive enough to significantly affect the position of Genentech’s Avastin for patients with lung cancer who can be treated with the product in the short term. However, doctors treating patients with NSCLC who cannot take Avastin may opt to prescribe Erbitux, which could lead to an additional $700 million in annual sales in the US.

Overall, probably one in five patients or less get Avastin, so there’s a huge opportunity outside of that in the long run, and the data are very competitive. Erbitux is expected to be filed for expanded US approval in NSCLC in the second half of this year, and the new indication could be added to the label by mid-2009. If approved, this will open new first-line treatment options for patients with non-small cell lung cancer regardless of histological subtypes, and potentially set a new standard in the first-line treatment of this disease.

cancer / competitive intelligence / lung cancer / market intelligence / market trends / NSCLC / oncology — Comments Off
28
May 08

Study showed Alimta improved survival in certain types of Non-Small Cell Lung Cancer

The type of non-small cell lung cancer (NSCLC) patients have may now influence their treatment regimen and, in turn, survival outcome according to the results of a major study published online in the Journal of Clinical Oncology.

NSCLC is the most common type of lung cancer and represents 85 to 90 percent of all lung cancers. According to the World Health Organization (WHO) Cancer Report, lung cancer is the world’s most common cancer and the leading cause of cancer death for both men and women. More than 1 million people die from lung cancer each year.

NSCLC is defined as a group of histologies i.e. tumour types differentiated by cellular structure. The most common NSCLC histology types are squamous (or epidermoid) carcinoma, adenocarcinoma, and large cell carcinoma. These histologies are often classified together because, to date, approaches to diagnosis, staging, prognosis, and treatment have been similar.

The study, the largest Phase III clinical trial in the first-line NSCLC setting, evaluated ALIMTA® (pemetrexed for injection) plus cisplatin versus GEMZAR® (gemcitabine HCl for injection) plus cisplatin, a standard of treatment in this setting. The trial met its primary endpoint of non-inferiority relative to overall survival.

Additionally, in a pre-planned histological analysis, patients with either adenocarcinoma or large-cell carcinoma had a statistically superior and clinically relevant improvement in overall survival when treated with the pemetrexed regimen in the first-line setting.

In comparison, patients with squamous cell histology were found to have a more favorable overall survival when treated with the gemcitabine regimen.

The overall survival of patients treated with either the pemetrexed regimen or gemcitabine regimen was found to be non-inferior, with a median survival of 10.3 months. However, when researchers reviewed survival rates according to histological analysis, it was found that patients with adenocarcinoma achieved 12.6 months of overall median survival when treated with the pemetrexed regimen compared to 10.9 months for those treated with the gemcitabine regimen. Patients with large cell carcinoma who were treated with the pemetrexed regimen achieved 10.4 months of overall median survival versus 6.7 months for those treated with the gemcitabine regimen. Both findings are statistically significant.

Patients with squamous cell histology were found to have a more favorable rate of survival when treated with the gemcitabine regimen, achieving 10.8 months of median survival, compared to the 9.4 months for those treated with the pemetrexed regimen. This finding was statistically significant.

The Phase III, randomized study compared the overall survival between pemetrexed+cisplatin versus gemcitabine+cisplatin in chemonaive patients (1,725) with stage IIIB or IV NSCLC who also exhibited a performance status of 0-1. Patients on the pemetrexed arm (862) were treated with pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) on day one every three weeks for up to six cycles. Patients on the gemcitabine arm (863) were treated with cisplatin (75 mg/m2) on day one and gemcitabine (1250 mg/m2) on days one and eight every three weeks for up to six cycles.

Hematologic grade 3/4 drug-related toxicities including neutropenia, anemia and thrombocytopenia were significantly lower for patients on the pemetrexed arm. Drug-related grade 3/4 febrile neutropenia and alopecia (all grades) were also significantly less on the pemetrexed arm. Drug-related grade 3/4 nausea was more common in patients treated with pemetrexed. Safety data by histology was generally consistent with the overall safety results.

Overall, patients with adenocarcinoma or large cell carcinoma histologies achieved improvement in overall survival when treated with Alimta (pemetrexed) based regimens.

While non-small cell lung cancer has typically been treated as one disease, this study confirms that histology, or tumour type, can provide a clue as to which treatment regimen works best for a particular tumor type. It suggests that if we can select the therapy for better results, we are closer to improving outcomes for lung cancer.

cancer / company news / competitive intelligence / lung / market intelligence / market trends / oncology — Comments Off
9
May 08

AZ and Iressa attempting a comeback in lung cancer?

Last week, AstraZeneca announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSA™) as a treatment for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have been pre-treated with platinum-containing chemotherapy.

The application was based on data from the Phase III INTEREST study, which showed that patients with pre-treated advanced NSCLC who received gefitinib had non-inferior overall survival to those treated with intravenous chemotherapy with a taxane (docetaxel). Gefitinib apparently had a more favourable tolerability profile than docetaxel and significantly more patients receiving gefitinib had an improvement in quality of life. In other words, they are attempting to do what Lilly did with Alimta in second-line treatment of NSCLC with their comparative trial against docetaxel.

This is the first time an Epidermal Growth Factor Receptor – Tyrosine Kinase Inhibitor (EGFR-TKI) has proven non-inferiority for overall survival relative to chemotherapy in patients with pre-treated advanced NSCLC. If the EU approve the therapy, it will be interesting to see how the US view the data.

The announcement represents a return to the spotlight for gefitinib, which had first-quarter sales of $58 million and is available in 36 countries. It was previously touted as a potential blockbuster, but those hopes collapsed in 2004 when results from a 1,700-patient study in people with advanced NSCLC who had failed previous chemotherapy, revealed that at the end of one year, just 27% of the Iressa group were still alive compared to 21% of placebo, a non-significant result.

AstraZeneca was allowed to keep the drug on the market in the USA, but its use was heavily restricted and no new patients were allowed access to the therapy unless they were taking part in a clinical trial. The company withdrew its application to market Iressa in Europe shortly after.

cancer / consulting / Gliobastoma / market intelligence / market trends / oncology — Comments Off
28
Apr 08

New cancer therapy being market tested for gliobastoma?

Glioblastoma multiforme is by far the most common and most malignant of the glial tumors, yet prognosis remains poor. Less than 5% of patients survive 5 years after diagnosis.

Preliminary data was recently reported at a cancer conference on an investigational compound has shown promise in prolonging survival among patients with recurrent glioblastoma. This compound, cediranib, was found to positively influence the outcome of the trial. The lead author, Dr. Batchelor (Massachusetts General Hospital Cancer Center in Boston), said that the primary outcome of this phase II study, a standard metric in this disease, is the proportion of patients who are alive without disease progression at 6 months, “Our percentage was 25.8%, and this compares favorably with historic controls, which are about 15%.” The study cohort consisted of 31 patients with glioblastoma who had failed previous therapy with radiation, surgery, and chemotherapy.

Cediranib (AZD2171), from AstraZeneca, is an oral potent panvascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor. It is a selective VEGF-signaling inhibitor that targets all 3 VEGF receptors.

AZD2171 has a half-life of 20 hours, which makes it compatible with once-daily dosing, and its primary target, VEGFR2, is expressed on glioblastoma endothelium. The researchers have observed the normalization of tumor vessels in patients with recurrent glioblastoma who received AZD2171 on a daily basis.

Newer Entries →
Content Protected Using Blog Protector By: PcDrome.