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cancer / competitive intelligence / health / liver cancer / market trends / oncology / pharma / strategy — Comments Off
28
Jul 08

Improving survival in Liver Cancer – at what cost?

No effective therapy is available for advanced hepatocellular carcinoma (liver cancer), it’s a terminal condition. Over 18,000 people typically die from it in the USA each year. It is much more common in Africa and East Asia where the risk of infection from Hepatitis B and C is much higher, which are associated with increased risk factors for the disease.

Hepatocellular carcinomaImage via Wikipedia

In this month’s New England Journal of Medicine, a randomised trial involving 602 patients with advanced hepatocellular carcinoma was reported. Sorafenib, a multikinase inhibitor of Raf, vascular endothelial growth factor receptor, and platelet-derived growth factor receptor, improved median survival by 3 months compared to placebo (10.7 vs. 7.9 months, P<0.001). Adverse events, including diarrhea and weight loss, were more frequent in patients receiving sorafenib.

Three months doesn’t sound a lot, but improvements in cancer survival nearly always occur in small increments. The other side of the coin is at what cost?

An editorial by Dr Lewis Roberts in the same journal noted the following:

“The pharmacy price of sorafenib is approximately $5,400 per month in the United States, {euro}3,562 per month in France, $1,400 per month in Korea, and $7,300 per month in China. Even in industrial nations, the high cost of new drugs produces significant stresses on health system budgets. There are substantial ethical implications in having effective therapies available for life threatening diseases that are priced beyond the reach of the populations most in need of therapy.”

Would you pay $15,000 for an extra three months of life?

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cancer / company news / competitive intelligence / Cougar / market intelligence / market trends / oncology / prostate — Comments Off
23
Jul 08

15 minutes of fame in oncology

Wow, my blog on abiraterone in advanced prostate cancer got picked up last night by TopUSAsites for prostate cancer.

It looks like the drug is going to be a hot topic for a while, but caution against the hype is advised until we see whether reduction in PSA and tumour shrinkage actually translates to what really matters to patients – improved survival and better quality of life.

What say you?

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cancer / competitive intelligence / market intelligence / market trends / NHL / oncology / radioimmunotherapy / rituxan / targeted therapy — Comments Off
20
Jul 08

A cancer patient’s inspiring story

A lady who was diagnosed with non-Hodgkin’s lymphoma (NHL) and relapsed on chemotherapy, tells her story about how she overcame the odds with a promising new approach called radioimmunotherapy:

VIDEO

There is always hope around the corner with new treatments coming on the market.

brain cancer / cancer / competitive intelligence / FGF / glioblastoma / market intelligence / market trends / oncology / Tie-2 — Comments Off
14
Jul 08

Cediranib (AZD2171) in Glioblastoma and brain cancer

The investigational drug AZD2171 (cediranib) from Astra-Zeneca may help shrink tumours and prolong survival of patients with a relatively common, aggressive type of brain cancer. In a phase II study of 31 patients with recurrent glioblastoma, researchers observed that daily treatment with cediranib decreased tumour volume by more than half in 56 percent of patients. These results were reported at the recent AACR meeting.

Nearly 26 percent of patients were alive and their cancer had not progressed six months into treatment. On average, patients experienced a progression-free survival of 117 days and overall survival of 221 days. Cediranib was also found to alleviate brain swelling, a major cause of morbidity among these patients.

Cediranib is a selective signaling inhibitor for vascular endothelial growth factor (VEGF), which promotes formation of new blood vessels that tumours need for nourishment and growth. The drug targets all three receptors for VEGF, one of which is expressed on the endothelial cells in glioblastoma.

Two of the 31 patients were removed from the current study because of toxicity (fatigue). Dose reductions, ie short breaks from the drug, were required for most patients, usually due to hypertension, diarrhea and fatigue.

By analyzing blood samples from patients, the researchers found that the biomarkers FGF (fibroblast growth factor) and Tie-2 were associated with tumour progression and could be used to predict treatment failure in this study population. FGF is a protein tied to new blood vessel growth; Tie-2 is a receptor that binds to and is activated by the angiopoietins – protein growth factors required for the formation of blood vessels.

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2
Jul 08

New treatment option for patients with liver cancer

Treatment with sunitinib (Sutent) slows tumour growth and reduces the risk of metastasis in patients with hepatocellular carcinoma, an aggressive cancer of the liver.

Hepatocellular carcinoma is a cancer that relies heavily on blood vessels for growth; sunitinib controls the growth of blood vessels and could therefore potentially play an important role for treatment.

Hepatocellular carcinomaImage via Wikipedia
Patients with this type of liver cancer have a very poor prognosis and the only currently available therapy is sorafenib. This study shows that it may be possible to effectively use sunitinib with manageable side effects, thereby providing patients with an alternative treatment option. Sunitinib (Sutent) is a small molecule tyrosine kinase inhibitor that targets multiple receptors, including VEGFR2, c-Kit and FLT3. These receptors may be present in cancer cells as well as in endothelial and immune cells.

Researchers enrolled 34 patients with advanced liver cancer and gave them 37.5 mg sunitinib daily on a standard four weeks on, two weeks off regimen. By 12 weeks, one patient had a partial response and 17 patients had stable disease. The median progression-free survival was four months and the median overall survival was 10 months.

Source:

AACR

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22
Jun 08

Cervical cancer vaccines

The UK has recently approved a second vaccine that protects against HPV called Cervarix from GSK, in addition to Gardasil from Merck. Both vaccines protect against HPV, but Gardasil also protects against gentical warts, which Cervarix does not.

Genital warts on a maleMale with genital warts – image courtesy of Wikipedia

The wholesale price for the two is exactly the same, £80.50, and the formal list price is also comparable at £240 per vaccination. Other European countries appear to have chosen Gardasil, for it’s extra protective effects. Genital warts are, of course, far more common than cervical cancer in Western Europe. Most women over 40 receive a regular annual Pap smear to screen for HPV and cervical cancer, hence the low rates compared to Latin America and Africa, where the smear test is considerably less common.

Guess which vaccine the NHS chose in it’s wisdom? Yes, Cervarix. Any parent wanting to innoculate their daughter with Gardasil will therefore have to get it on private health plans at a much greater cost.

Meanwhile, although a small number of boys were included in the trial, there were insufficent numbers to gain approval for use in the male population. If you are going to reduce the spread of genital warts and HPV in the population, it makes sense to innoculate both surely?

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breast cancer / cancer / competitive intelligence / market intelligence / market trends / oncology / pipeline — 1 Comment
11
Jun 08

Are Her2 inhibitors an alternative to chemo in breast cancer?

Herceptin Fab (antibody) - light and heavy chainsImage via WikipediaSeveral studies exploring the use of lapatinib (Tykerb, GlaxoSmithKline) in metastatic breast cancer have suggested that it may offer an alternative to chemotherapy in this setting, both as monotherapy, and in combination with other targeted therapies.

One study explored the use of lapatinib alone, whereas others investigated combinations with trastuzumab (Herceptin, Genentech/Roche), with bevacizumab (Avastin, Genentech/Roche), and with the investigational agent pazopanib (under development by GlaxoSmithKline).

Studies presented at American Society of Clinical Oncology opened up an interesting debate regarding whether biological therapy without chemotherapy for metastatic breast cancer is feasible.

The efficacy of these targeted agents is higher when they are combined with chemotherapy, and the toxicity of these agents in combination needs to be explored further. Hence, the preferred front-line choice for metastatic breast cancer is presently trastuzumab with chemotherapy, and the evidence suggests that continuation of trastuzumab is the best option for patients who progress. Combining drugs that have different targets is also a promising option.

Lapatinib is currently approved in the US for a very narrow indication in combination with capecitabine (Xeloda, Roche) for advanced metastatic HER2+ breast cancer in women who have received previous chemotherapy, including an anthracycline, a taxane, and trastuzumab. A similar approval in Europe is pending with the EMEA.

The largest of the new trials presented was a phase 3 study of lapatinib monotherapy compared with a combination of lapatinib and trastuzumab (EGF104900). Both of these drugs target HER2+ breast cancer, but trastuzumab (a monoclonal antibody) is a large-protein molecule that targets the part of the HER2 protein on the outside of the cell; lapatinib (an oral drug) is a smaller molecule that enters the cell and blocks the function of this and other proteins intracellularly. The combination effectively attacks HER2 from multiple angles.

The trial involved 269 patients with HER2+ breast cancer who had documented progression on trastuzumab in the metastatic setting. The combination of lapatinib plus trastuzumab showed a significant increase in progression-free survival, compared with lapatinib alone (12 weeks vs 8.1 weeks). This translates into a 27% reduction in the risk for disease progression (hazard ratio [HR], 0.73; P = .008). The overall clinical-benefit rate (the response rate and the rate of durable stable disease) for the combination was double that for monotherapy (24.7% vs 12.4%; P = .01). There was a trend toward improved overall survival.

More data on the role of combined HER2+ therapy in combination with chemotherapy will be available soon from the ongoing ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) study. ALTTO is being conducted in less-heavily pretreated patients with early-stage disease.

A trial of lapatinib plus bevacizumab was reported in a small phase 2 single-group study, conducted in 32 patients who had received a median of 5 previous metastatic breast cancer therapies. 28 of these 32 patients had received prior treatment with trastuzumab.

The combination resulted in a 34.4% clinical-benefit rate (defined as complete response plus partial response plus stable disease at 24 weeks or more), and 62.5% of patients were progression free at week 12.

The most common adverse events were diarrhea (81%), rash (66%), nausea (56%), fatigue (56%), and vomiting (46%). There were 2 grade 2 asymptomatic LVEF decreases, 1 grade 3 gastrointestinal hemorrhage, and 1 grade 3 hypertensive event.

Overall, blocking both the HER2 and the VEGF pathways led to anticancer activity for even heavily pretreated patients with metastatic breast cancer that could potentially advance the treatment of this high-risk disease.

A combination study of lapatinib plus pazopanib, where both drugs were taken orally once daily, suggested that they might provide a potential future treatment option for HER2+ breast cancer. It involved 141 patients and compared the combination with lapatinib monotherapy.

The results confirmed the efficacy of lapatinib monotherapy and showed a trend toward better outcomes with the combination. At 12 weeks, 36.2% of patients taking the combination and 38.9% taking the monotherapy experienced disease progression (P=.37). The response rate was 44.9% with the combination and 28.8% with the monotherapy according to investigator assessment, and 36.2% vs 22.2%, respectively, according to independent assessment.

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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.

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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.

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14
May 08

Market trends: cancer vs. ophthalmology drugs

Today I was at the ophthalmologists office getting my eyes tested for some new glasses. The technician and I were chatting convivially about the pros and cons of Avastin versus Lucentis for wet age-related macular degeneration (AMD).

Later, while looking at the National Institutes of Health (NIH) site on the internet, I noticed they have finally started an independent trial that is designed to show how the two drugs stack up against each other. Both inhibit Vascular Endothelial Growth Factor (VEGF) but have different approved uses and indications.

Lucentis has been FDA-approved for use against wet AMD. Avastin isn’t,it’s approved for treatment of cancers such as colorectal carcinoma. Ophthalmologists and retinal surgeons have, however, commonly used it off-label, saying it’s almost as effective as Lucentis, if not as effective. And Avastin also costs much less, i.e. $50 rather than $2,000. The challenge was that Avastin needed to be compounded by pharmacies and last year Genentech moved to restrict sales of Avastin to those pharmacies who were compounding Avastin for ophthalmology use, stating that there was a risk of microbial contamination from compounding and the FDA were concerned about the re-packaging.

The NIH decided to take matters into its own hands and perform a trial to answer the question. Time will tell. If the trial shows no difference between the two, expect Avastin to cannibalise sales of Lucentis and insurers/payers to exert their muscle in favour of the cheaper alternative.

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