INFO please...re. cediranib fate

[Yosef Landesman]

Hello everyone!

Please read my Feb 4 2012 post on the main page of our website - Update on Cediranib development for Alveolar Soft Part Sarcoma

At least for the near future, Cediranib is not disappearing. AstraZeneca, the developer of Cediranib, has decided to transfer the development of Cediranib to the National Cancer Institute (NCI). AstraZeneca transferred 100 kg of Cediranib to the NCI for that purpose, and the NCI opened a new Phase 2 clinical trial for ASPS patients. The goal of the new NCI trial is to confirm the early Phase 2 results, and to compare Cediranib to Sunitinib, another drug that was tested on 9 ASPS patients at the Istituto Nazionale Tumori, Milan, Italy.

The NCI is making efforts to make sure that the study will be conclusive. Therefore, travel and additional support will be given to every ASPS patient who wants to participate in the trial at the NCI. The NCI will accept and also pay travel for ASPS patients who are not US residents. Non-US residents need to arrive to any US port and then their flight to the NCI, their treatment and minimal stay expenses will be paid by the NCI!

For full details please read the details in the following link: Sunitinib or Cediranib for Alveolar Soft Part Sarcoma. For more information, contact the NCI Referral Office at 1-888-NCI-1937 with the study number NCT01391962.

I am hopeful that we are now much closer to the day when the first effective drug for treatment of ASPS is identified, and available for ASPS patients!

Best Wishes,
Yossi

[Bonni Hess]

Dear Yossi,
Thank you very much for the shared information regarding Astra Zeneca's transfer of the development of Cediranib to the NCI, and thank you too for all of your efforts to obtain this important information. While the plan to continue development of Cediranib through the NCI is very good and encouraging news, I am concerned about the implication that there is still no guarantee that production of Cediranib will continue or that it will definitely remain available in Clinical Trial or as an approved drug to all ASPS patients, both domestic and international, in the future. I have written a personal appeal to Dr. Jonathan Wiest, in the office of Cancer Research and Funding at NCI (although I am unsure if he is the correct person to address concerns to regarding Cediranib), but disappointingly have not yet received a response from him or anyone else at NCI. I will continue to closely and actively follow and update any new information about this critically important issue, and urge all ASPS Community members to do so also.
With deepest gratitude, special caring thoughts, and continued Hope,
Bonni

[Amanda]

Thank you Yossy and everyone making it there lives job to help find a cure for ASPS!
This is wonderful news!!

[Amanda]

Hello Olga
I think the larger the team the better! So i would also see if NCI will help this group also?

Hello Yossi
Is this group also going to be able to go to the NCI for Ced?

It turns out that we are not the only group that is interested to see the further cediranib developments:
European Journal of Cancer has just published an article:

Cediranib monotherapy in patients with advanced renal cell carcinoma: Results of a randomised phase II study
http://www.ejcancer.info/article/PIIS0959804911010719

Their conclusion:
Cediranib monotherapy demonstrated significant evidence of antitumour activity in patients with advanced renal cell carcinoma.

May be we should contact the group (I think there is a RCC group?) to coordinate the efforts or at least to let them know about the possible plans to stop cediranib development?

[Yosef Landesman]

Dear Bonni, Amanda, Olga

The information that I posted is the current plan for Cediranib in the US. I agree that it does not give an immediate answer for our ASPS community in the rest of the world. Also, it is my concern that if the comparative study with Sunitinib will not be significant enough, then Cediranib will not be approved and in that case Bonni's concerns will become reality. Therefore connecting and working together with others is a great idea.

Best Wishes,
Yossi

[Johannes]

Dear all,

A huge thank you to those who have posted about the future development of Cediranib. As I indicated in previous posts, I think AstraZeneca had already decided a while ago that it wouldn't continue developing this drug, but transferring the property rights to e.g. the NCI, who might also take over the development aspect, might be an encouraging avenue. If AstraZeneca is not willing to go ahead, then It would make sense, at least, to give the NCI access to all its data and allow the institute to develop the drug (assuming that the NCI has an interest in doing that).

I find it a bit strange that nobody at the NCI talked with Elisa about all this when she went down last week, although she did briefly see Dr. Kummar. It might mean that the trial is "safe", at least for a while, but we'll certainly ask for more information next time.

We'll also raise the issue with Elisa's oncologist at home on her next appointment, and with the pharmacist of the hospital who was very helpful in the past and who might have more direct access to people from AstraZeneca.

We'll of course keep you up to date. Take care,
Johannes

[Bonni Hess]

Dear Johannes,
Thank you for your post. It is very perplexing that no one at NIH has provided Elisa with information regarding Astra Zeneca's plans to discontinue development of Cediranib, and the potential plan to transfer the intellectual property of Cediranib to NIH. Brittany was provided with a printed information sheet over a month ago by the Clinical Trial Staff at Cross Cancer Institute regarding Astra Zeneca's announced decision, and one would certainly think that this same courtesy would be extended to all patients participating in Cediranib Clinical Trials given the relevance and signficance of this matter to the patients.
I Hope that Elisa is continuing to have a successful response to the Cediranib with continued stable disease and tumor shrinkage, and that she is tolerating the side effects of the medication well. I will be anxiously awaiting your next update on the results of Elisa's next status scans, and holding very tight to Hope for continued good news. Please give her my best wishes.
With special caring thoughts, healing wishes for Elisa, and continued Hope,
Bonni