Axtinib Phase II Study Shows Promise in Pancreatic Cancer

Pfizer's multi kinase VEGFR inhibitor axitinib has shown interesting results in Phase II study in Pancreatic cancer.

Interim results from a Phase II trial: axitinib + Gemzar median OS 6.9 months vs 5.6 months for single-agent Gemzar - a 26% reduction in the risk of death. In a subset of 94 patients with a good performance status, the combination reduced the risk of death by 33%

Word on the street is that axitinib is about to move into Phase III in pancreatic cancer - in 2H 2007

Gardisil has a competitor

In an article published in journal Lancet, Glaxo Smith-Kline announced that their HPV vaccine Cervarix has completed the pivotal clinical trials, and it is highly effective against HPV, and cervical cancer.

The researchers concluded that Cervarix appears highly effective in preventing HPV and ultimately cervical cancer among women aged 15 to 25 years. Only future trials will determine the clinical utility of the already approved cervical cancer prevention vaccine Gardasil® and Cervarix.

Glaxo plans to file marketing applications all around the world, which in some ways should give Merck some concern. Cervarix will compete with Gardasil for the same patients. On the other hand, it should bring some relief to Merck to have two companies promote the virtues of a vaccine than one, given the controversy surrounding the promotion of the vaccine as a means of promoting immoral behavior among young women.

NY Times has an interesting article on how the vaccine development was fraught with difficulties. Makes for an interesting reading.

RON receptor involved in Pancreatic Cancer

Recepteur d’Origine Nantais, or RON receptor tyrosine kinase and its ligand, macrophage-stimulating protein, have been long implicated in progression and metastasis of tumors including breast cancer. Now comes a study from the scientists Andrew Lowy, MD, and Susan Waltz, PhD, at University of Cincinnati that implicates involvement of RON in aggressive pancreatic tumors.

From their press release

The team found that the RON receptor was active in 93 percent of what is known as pancreatic intraepithelial neoplasia, an early form of pancreatic duct cancer. In addition, the receptor was present in 79 percent of primary pancreatic cancers and 83 percent of metastatic cancers

You can get the July 1 issue of Cancer Research to read the entire article. Articles are posted free online after three to four weeks of publication. Look for Ryan Thomas, et al publication titled, "The RON Receptor Tyrosine Kinase Mediates Oncogenic Phenotypes in Pancreatic Cancer Cells and is Increasingly Expressed during Pancreatic Cancer Progression"

Sunitinib to be tested in first line mCRC

Pfizer is moving into metastatic Colorectal cancer with the announcement of a multinational Phase III study with sunitinib malate, Sutent. The study will enrol 700 patients in South America, Canada, Europe and Asia. Conducting a first line study would be a herculean task in the United States as the first line is pretty much the domain of Avastin based therapy.

Penetration in first-line use is probably at or above 75%, according to (Jason) Napodano (of Zacks Equity Research). Over the next few quarters Napodano predicts that Avastin can achieve near 80% penetration in this indication.

For more details click here

Hence increasingly companies in Oncology arena are embarking on conducting multinational trials where they can ask the questions worth asking about the activity of the compound. Question is, how do you get a drug registered in United States based on a study done out side of United States? And the answer may be while that it may be difficult to get the first indication for a new drug based on a study done entirely outside of US, perhaps its not unthinkable to approach the FDA for a new indication for a drug that is already on the market, with ex-US data. Still, it would not be impossible to source a few patients in the US, despite the Avastin's looming presence.

All this is nothing but good news for the patients as more options mean more chances that one will find something that works!