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ASCO 2015 Round-Up: Immunotherapy in the Spotlight

As June marks Cancer Immunotherapy Awareness Month, I wanted to reflect on some of the key scientific takeaways from the American Society of Clinical Oncology’s (ASCO) annual meeting, and how these advancements are shaping the future of immunotherapy and our work at OncoSec. After digesting the news and outcomes, I’ve summarized my personal highlights and research insights from the week.

OncoSec Hosts Intratumoral Immunotherapy Summit

To kick-off ASCO activities, OncoSec hosted an Intratumoral Immunotherapy Summit on Thursday, May 28th, which gathered 30 key opinion leaders from across the world to discuss guidelines and definitions relevant to the immuno-oncology field and intralesional therapies. OncoSec’s Chief Medical Officer, Mai H. Le, MD, moderated the discussion and was joined meeting co-chairs: Drs. Robert Andtbacka, Holbrook Kohrt, and Adil Daud.

Not only was this a great opportunity to meet our immunotherapy peers face-to-face, but the meeting also provided a robust and multifaceted discussion on the topic of intratumoral therapy. Experts discussed a myriad of topics, including: the definition of intralesional therapy; approach for assessing regression of lesions; measuring an abscopal effect; and methods of measurement and evaluation of tumor burden. The Summit was truly a thought-provoking and in-depth look at intratumoral immunotherapy, and we will continue to lead the discussion to further address and define these topics.

The expectation from this type of meeting is the development of consensus guidelines and a “white paper” from the KOLs on the discussion areas, greater leadership, and program presence of “intratumoral immunotherapy” in future scientific meetings. After some fairly intense discussion, this meeting ended on a positive note by one of our investigators who quipped, “…that ASCO should watch out, because the ‘local guys’ are here!” Hear, hear!

Unlocking the Potential of Anti-PD-1 Therapies

Immunotherapy, and particularly anti-PD-1 therapies, continued to generate buzz and was the focus of many discussions at ASCO. By way of background, there are three checkpoint inhibitor therapies approved by the U.S. Food and Drug Administration (FDA). The first, an anti-CTLA-4 monoclonal antibody ipilimumab (Yervoy) was approved for the treatment of metastatic melanoma in 2011.  Last year, two PD-1 inhibitors, nivolumab (Opdivo®) and pembrolizumab (KEYTRUDA®), were approved for the treatment of advanced melanoma.1

Research is now expanding to see if these treatments can provide improved care for people with other types of cancer. In a Phase III clinical trial, we saw that nivolumab showed unprecedented survival for people with non-small cell lung cancer (NSCLC). In a separate early-stage study, nivolumab also showed encouraging results as a treatment for advanced liver cancer. Pembrolizumab showed great promise from a Phase I clinical trial in recurrent and advanced squamous cell head and neck cancer; 25% of patients had tumors that shrank after taking pembrolizumab.

We continue to see PD-1 inhibitors change the course of cancer care and improve the lives of patients. These are truly encouraging data – and with OncoSec’s clinical pipeline in head and neck cancer, metastatic melanoma, and triple negative breast cancer – we believe that our technology can further improve patients’ responses to PD-1 inhibitors.

Strong Data for Combination Approaches

Research from a Phase III study combining ipilimumab and nivolumab to treat patients with advanced-stage melanoma proved to be a game changer in the immuno-oncology field. This study showed that 58% of patients who took both medicines (ipilimumab and nivolumab) had tumors shrink by at least a third over the course of a year. While these results are promising, researchers found that combining these treatments could also lead to severe side effects and prove to be very expensive for patients to afford.

As combination approaches continue to change the immunotherapy landscape, we’re excited about our ongoing research into this arena. At OncoSec, we believe that our core technology will drive a CD8-specific immune response and the important tumor infiltrating Lymphocytes (TILs) into the tumor microenvironment.  These are the immune cells required for both a local and systemic response and are potentially necessary in order to increase the proportion of patients who will respond to anti-PD-1 and other checkpoint therapies. Our Phase II trial results in metastatic melanoma has led to an exciting new collaboration with the University of California, San Francisco, who will now be testing the hypothesis that ImmunoPulse IL-12 can enhance response to Merck’s anti-PD-1 treatment, KEYTRUDA® (pembrolizumab).

Talking About Cost of Treatments

Another major topic of discussion was the cost of immunotherapies and the potential “financial toxicity” these treatments could have in the marketplace. As these drugs start getting approved in combination, there’s speculation that the cost of certain drugs together will overwhelm the system. Analysts are saying these treatments can cost approximately $100,000-150,000 per patient per year.

At ASCO, there were presentations regarding how cost does not necessarily reflect drug value and we should consider cost as part of a patient’s treatment decision. The cost of cancer care continues to be an ongoing discussion in oncology as prices may affect patient care due to significant financial burden. For me, it’s refreshing to see physicians start talking about price as it can impact a doctor’s ability to provide quality care.

Consensus Summit for Intratumoral Immunotherapy

The statements or opinions expressed on this site are my own and do not necessarily represent those of my employer OncoSec Medical.

References:

1. Cancer Research Institute. Timeline of Progress. http://www.cancerresearch.org/our-strategy-impact/timeline-of-progress/timeline-detail