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Mar 7, 2019

Key Takeaways from the ASCO-SITC Clinical Immuno-Oncology with Dr. Steven Eric Finkelstein.

Welcome to the "ASCO Daily News podcast." I'm Lauren Davis and joining me today is the "Immuno-oncology Daily News" Associate Editor, Dr. Steven Eric Finkelstein with Florida Cancer Affiliates the US Oncology Network. Dr. Finkelstein, welcome to the podcast.
Thank you so much for having me. The Immuno-oncology Symposium just concluded on Sunday. How was this event compared to last year's?
Well, this year's event was, again, extremely exciting. This year's event featured research and discussion surrounding themes of patient-centered rational steps to move the field of immuno-oncology towards the future. Now, as many of us know, immuno-oncology has dramatically altered the treatment landscape for many malignancies, and this progress has been extremely rapid over the last decade.
As the field has progressed, researchers and clinicians are pushing it towards a better understanding of how immunotherapy can affect patients and the best and most rational combination approaches can improve responses and long-term outcomes.
What presentations stood out to you?
Another exciting area of research was that the combination of lenvatinib and pembro yielded promising antitumor activity and progression-free survival in patients with metastatic urothelial carcinoma. In abstract 11, a Phase Ib/II study was reported. And as we know, urothelial cancer can account for 90% of all bladder cancers.
Pembro monotherapy is currently approved as a first-line therapy in patients who are ineligible to receive cisplatin or platinum-based chemotherapy. It's also approved as a second-line treatment for patients with advanced or metastatic urothelial cancer. Lenvatinib, a multikinase inhibitor, a VEGFR-1 through 3, FGFR-1 through 4, PDGFR-alpha, RET, and KIT is used as a single agent in several malignancies, including thyroid cancer and hepatocellular cancer.
Dr. Vogelzang, who presented the results of the study, discussed the Phase II portion of the study, which included 20 patients with histologically confirmed metastatic urothelial carcinoma. The primary outcome in the trial was immune-related resist objective response at 24 weeks. Five patients achieved such a response for an overall response rate at 24 weeks of 25%.
Dr. Vogelzang's conclusion was that lenvatinib plus pembro demonstrated promising antitumor activity with manageable adverse events. The response rate warranted further investigation and lenvatinib plus pembro combination will be studied in a Phase III trial in urothelial carcinoma.
What other research were you interested in?
A Phase Ia/Ib trial was launched in order to evaluate the safety of LY3321367, an anti-T cell immunoglobulin-domain and mucin-domain containing molecule 3, or TIM-3 antibody. Administered alone or in combination to LY3300054, which is an antiprogrammed death ligand, or PD-L1 antibody in patients with advanced, relapsed, or refractory solid tumors.
An analysis of the trial that was presented by Harding at the meeting in Abstract 12. This focused on the safety, efficacy, pharmacokinetics, and pharmodynamic results seen with these treatment regimens. The key points are as follows-- treatment-related adverse reactions were mild, i.e. Grade two or less, in both treatment groups except for one patient with a Grade three anemia in Arm B.
No dose-limiting toxicities, dose-limiting equivalent toxicities, treatment-related serious adverse events, or death was observed in either treatment arm. Approximately 68% in Arm A and 88% in Arm B of patients were positive for treatment emergent antidrug antibodies related to the LY3321367. Despite antidrug antibodies, there was no effect on pharmacokinetics noted
That's great. Were there any education sessions that caught your attention?
I think at the 2019 ASCO SITC Clinical Immuno-Oncology Symposium, what really struck me were the keynote addresses. On March 2, the keynote lecture from Dr. Rafi Ahmed of Emory University examined the basic scientific underpinnings of the field and focused deeply on T cell exhaustion and differentiation.
In a second keynote address, Dr. Jedd Wolchok, of Memorial Sloan Kettering, took a broader look of the future of immunotherapy. And his main thesis was there was a need for a more rational approach to combination therapies. Indeed, it is apparent that the combination of therapies will be an important role for our future.
That's wonderful. Were there any other takeaways that were important during the symposium?
ASCO and the Society of Immunotherapy of Cancer, SITC, have really focused on developing recommendations for clinical trial reporting. Indeed, we need trial reporting that addresses the unique efficacy, toxicity, combination, and sequencing aspects of immuno-oncology treatments.
As many know, ASCO and SITC had convened a working group that consisted of medical oncologists, immunologists, clinical research, biostatisticians, and representatives from industry and government to develop important recommendations, also known as Trial Reporting in Immuno-oncology, or TRIO recommendations. The recommendations based on expert consensus are important given that existing data to support evidence-based recommendations are limited.
The recommendations given by TRIO are intended to improve the reporting of IO clinical trials and thus, provide more complete evidence on the relative benefits and risks of immuno-oncology. Given the rapid expansion of the number of IO clinical trials and ongoing improvements to evidence base using IO treatments and clinical care, it is apparent that these recommendations will likely need regular revision.
And the annual meeting of ASCO and SITC will be an important place for TRIO recommendations to continually be updated.
Thank you. Again, today, my guest has been Dr. Steven Eric Finkelstein. Thank you so much for being on our podcast today.
It's been an absolute pleasure. Thank you so much.
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