Impact of Academic Collaborations in mHSPC Trial: ENZAMET - Chris Sweeney
June 5, 2019
Chris Sweeney and Alicia Morgans discuss how the academic collaboration for ENZAMET (Addition of Enzalutamide to Standard of Care in Metastatic Hormone-Sensitive Prostate Cancer) became a reality and initiated in November 2014. The ENZAMET study was led by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group. ENZAMET (ANZUP 1304) is a global collaborative investigator-initiated trial led by ANZUP Cancer Trials Group and sponsored by the University of Sydney, in collaboration with Canadian Cancer Trials Group, Dana-Farber Cancer Institute, and Cancer Trials Ireland (enrolling patients from Ireland and the United Kingdom). Astellas Pharma provided drug and financial support but was not involved in study conduct or data analysis. ANZUP receives infrastructure funding from the Australian Government through Cancer Australia.
Biographies:
Biographies:
Christopher Sweeney, MBBS, Professor of Medicine, Harvard Medical School, Dana Farber Cancer Institute.
Dr. Sweeney has focused his academic career on the management of genitourinary malignancies, including prostate, bladder, testis, and renal cell cancer. His research interest has been primarily focused on drug development. This has included (i) design and conduct of phase I trials of new agents or new combinations that assess the safety and distribution of the drug in the body as well as the anti-cancer activity of the therapy; (ii) assessment of genetic variants and blood markers to try and define signatures that identify patients who are destined to benefit from a therapy; (iii) design and conduct of phase 2 and 3 clinical trials with a focus on bladder and prostate cancer and (iv) drug discovery and evaluation in the laboratory to guide clinical trial design.
Alicia Morgans, MD, MPH, Associate Professor of Medicine in the Division of Hematology/Oncology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.
Related Content:
Overall Survival Results of a Phase III Randomized Trial of Standard-of-Care Therapy with or without Enzalutamide for Metastatic Hormone-Sensitive Prostate Cancer: ENZAMET, an ANZUP-led International Cooperative Group Trial
ENZAMET NCT02446405: Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer
TITAN NCT02489318: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Overall Survival Results of a Phase III Randomized Trial of Standard-of-Care Therapy with or without Enzalutamide for Metastatic Hormone-Sensitive Prostate Cancer: ENZAMET, an ANZUP-led International Cooperative Group Trial
ENZAMET NCT02446405: Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer
TITAN NCT02489318: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Read the Full Video Transcript
Alicia Morgans: Hi. I am thrilled to have here with me today, Dr. Chris Sweeney who is a GU medical oncologist and Professor of Medicine at the Dana-Farber Cancer Institute. Thank you so much for being here with me today Chris.
Chris, I think one of the most impressive things about the ENZAMET study from my perspective, is that this was really an academic collaboration that was able to answer such a large question with an international population. Can you just tell everyone how you were able to make that happen because that in itself I think is quite an accomplishment?
Chris Sweeney: Metastatic hormone-sensitive prostate cancer has really not been a disease that the pharmaceutical industry have focused on because of the timelines to getting the readouts for overall survival take such a long time. That’s changed quite recently. After the CHAARTED study and the STAMPEDE where we showed we could get results in a reasonable timeframe. There's started to be more interest in support for clinical trials by in the hormone-sensitive space.
At this meeting, there's the Janssen sponsored study, TITAN, which shows the benefit for apalutamide, very similar to enzalutamide. I approached Astellas a while ago and said, "Your drug works in castration-resistant, why don't we do what we did with CHAARTED and try and evaluate it in the early setting?"
There was some internal negotiations as to whether that was a priority for the company or not but fortunately they said, "Yes, we can run that as an academic study, an investigator-sponsored study." We were able to pull a great group together. ANZUP and NHMRC Clinical Trial Center, did an amazing job of getting the study up and running. We pulled in the Dana-Farber Cancer Institute as one US site. Hopefully in future efforts we'll have more US sites.
Canada, United Kingdom and Ireland and of course New Zealand as part of the Australia New Zealand relationship. We did this as a team sport. Just the willingness of people to do an investigator-sponsored study with not being reimbursed that well for the clinical trial and conduct and putting the effort into it was a great, great, great collaboration and a true privilege to have been part of that.
The other thing about this academic collaboration that was really gratifying was that we were able to amend, we were able to be nimble. The data for docetaxel, CHAARTED, came out in if I remember correctly, June 2014 and we had the amendment written and activated by November 2014.
Alicia Morgans: Wow.
Chris Sweeney: Even before the publication because of the delays.
Alicia Morgans: Yes, of course.
Chris Sweeney: We were able to operate and change because we thought that was the right thing to do as an academic effort. We did it concurrently. We said, as you have you said, the interesting thing is the concurrent docetaxel, not the prior docetaxel. We, the academics, were able to drive that forward and make that change. We were then able to also make an amendment quickly for the interim analysis so that we could get an early readout.
Every one of 83 sites around the world collaborated to do this and make this happen. As much as there's an advance for clinical trial care, clinical care for patients with prostate cancer, there's an advance I think here, for us to do other clinical trials and we've got ENZARAD which is the radiation study which is accrued. Another study that we're going to joining with PrECOG that you're helping with as well, Dr. Morgans, DAZZLEHIGHCAP an adjuvant study with darolutamide in this space.
The team is coming together to advance clinical care in a more efficient manner, collaborating with industry and working hand in glove.
Alicia Morgans: I really think that above all what that this shows us is that we work together collaboratively with all these institutions and all of these countries, really taking the time to make the effort and maybe not necessarily get all their funds recouped even, that we can do these things for patients and really move the needle if we do it together.
Thank you for your time Chris.
Chris Sweeney: You're very welcome. Thank you very much for the opportunity.
Alicia Morgans: Hi. I am thrilled to have here with me today, Dr. Chris Sweeney who is a GU medical oncologist and Professor of Medicine at the Dana-Farber Cancer Institute. Thank you so much for being here with me today Chris.
Chris, I think one of the most impressive things about the ENZAMET study from my perspective, is that this was really an academic collaboration that was able to answer such a large question with an international population. Can you just tell everyone how you were able to make that happen because that in itself I think is quite an accomplishment?
Chris Sweeney: Metastatic hormone-sensitive prostate cancer has really not been a disease that the pharmaceutical industry have focused on because of the timelines to getting the readouts for overall survival take such a long time. That’s changed quite recently. After the CHAARTED study and the STAMPEDE where we showed we could get results in a reasonable timeframe. There's started to be more interest in support for clinical trials by in the hormone-sensitive space.
At this meeting, there's the Janssen sponsored study, TITAN, which shows the benefit for apalutamide, very similar to enzalutamide. I approached Astellas a while ago and said, "Your drug works in castration-resistant, why don't we do what we did with CHAARTED and try and evaluate it in the early setting?"
There was some internal negotiations as to whether that was a priority for the company or not but fortunately they said, "Yes, we can run that as an academic study, an investigator-sponsored study." We were able to pull a great group together. ANZUP and NHMRC Clinical Trial Center, did an amazing job of getting the study up and running. We pulled in the Dana-Farber Cancer Institute as one US site. Hopefully in future efforts we'll have more US sites.
Canada, United Kingdom and Ireland and of course New Zealand as part of the Australia New Zealand relationship. We did this as a team sport. Just the willingness of people to do an investigator-sponsored study with not being reimbursed that well for the clinical trial and conduct and putting the effort into it was a great, great, great collaboration and a true privilege to have been part of that.
The other thing about this academic collaboration that was really gratifying was that we were able to amend, we were able to be nimble. The data for docetaxel, CHAARTED, came out in if I remember correctly, June 2014 and we had the amendment written and activated by November 2014.
Alicia Morgans: Wow.
Chris Sweeney: Even before the publication because of the delays.
Alicia Morgans: Yes, of course.
Chris Sweeney: We were able to operate and change because we thought that was the right thing to do as an academic effort. We did it concurrently. We said, as you have you said, the interesting thing is the concurrent docetaxel, not the prior docetaxel. We, the academics, were able to drive that forward and make that change. We were then able to also make an amendment quickly for the interim analysis so that we could get an early readout.
Every one of 83 sites around the world collaborated to do this and make this happen. As much as there's an advance for clinical trial care, clinical care for patients with prostate cancer, there's an advance I think here, for us to do other clinical trials and we've got ENZARAD which is the radiation study which is accrued. Another study that we're going to joining with PrECOG that you're helping with as well, Dr. Morgans, DAZZLEHIGHCAP an adjuvant study with darolutamide in this space.
The team is coming together to advance clinical care in a more efficient manner, collaborating with industry and working hand in glove.
Alicia Morgans: I really think that above all what that this shows us is that we work together collaboratively with all these institutions and all of these countries, really taking the time to make the effort and maybe not necessarily get all their funds recouped even, that we can do these things for patients and really move the needle if we do it together.
Thank you for your time Chris.
Chris Sweeney: You're very welcome. Thank you very much for the opportunity.