LUNAR Trial: Did Emory Get Caught in the Hype?

by Brian Shields

The LUNAR trial is a phase 3 clinical trial that evaluated the safety and effectiveness of Tumor Treating Fields (TTFields) therapy for patients with metastatic non-small cell lung cancer (NSCLC). The trial was sponsored by Novocure, the developer of the TTFields device. The Lunar Trial led to significant drama at the recent American Society of Clinical Oncology (#ASCO23) Meeting in Chicago. IL. Despite the positive press releases by Novocure, the Novocure stock plummeted upon the release of the data at ASCO23. Even Jim Cramer, a big Novocure Fan advised against owning the stock on Mad Money. Oncologists expressed disappointment with the clinical trial design of Novocure's LUNAR trial and questioned the clinical application of the LUNAR Trial results. However, Emory University sung a different tune. 

Emory University played a significant role in the media communications of the LUNAR trial. The trial was led by Ticiana Leal, MD, a medical oncologist and researcher at Emory University's Winship Cancer Institute. In early June, Emory University's press release highlighted the promising results of the trial and emphasized the potential for TTFields therapy to benefit patients with limited treatment options. In fact, even after two months of the public criticisms of the LUNAR Trial, Emory continued to communicate glowing praise of the LUNAR trial in their media communications about the Lancet Oncology publication..

Public criticism of the LUNAR Trial started with the LUNAR Trial discussant, Dr. Rebecca Heist at ASCO23. “The major caveat for me is that the study design does not reflect the current standard of care,” claimed Dr. Rebecca Heist to a room full of peers at ASCO. Oncology Thought Leaders further shared their thoughts on Twitter. Dr. Stephen Lui from Georgetown was very specific in his criticisms of LUNAR. In fact, Dr. Stephen Lui publicly opposed the conclusions of Emory's Ticiana Leal. Liu clearly stated in his Tweet, "In my opinion, this is NOT yet part of SOC." contrasting with Leal's conclusion slide he shared from ASCO23.

Dr. Lui reiterated his concerns of the LUNAR Trial design after The Lancet Oncology published the results in late August:

Dr. Jack West, another Lung Cancer Key Opinion Leader from City of Hope in Los Angeles, also shared his criticisms of LUNAR on Twitter.  Primarily he doubts that there will be much uptake where immunotherapy is standard of care in 1L Lung Cancer. Dr. Clay Reed responded to Dr. West with a key criticism of the trial with regards to the unique support provided only to the experimental arm. Per Dr. Reed, "The increased follow up by research RNs, etc of the TTFs patients probs has some befit alone."

Dr. Olivier further expanded upon the imbalance of the LUNAR trial design in his Twitter criticism. He outlines the reason for a sham-controlled trial and points out the extra level of care that TTField patients received versus control in the LUNAR Trial.  He also provides a helpful summary of what a sham-controlled study would be.

Despite these criticisms of the LUNAR Trial Design, Emory's Ticiana Leal called the LUNAR Trial "paradigm shifting" in her video interview.  She made no mention of the above criticisms from the Lung Cancer Community in this video presentation.

Does a university have an obligation to address criticisms of a major clinical trial which they conducted for a Medical Device Company? Should Dr. Ticiana Leal reply openly to the oncologist criticisms above regarding the LUNAR Trial?

UPDATE: Since the ASCO23 drama, Novocure had another recent failure with regards to their trial for ovarian cancer. 

Below is the price chart for Novocure over the last several years. 

UPDATE: 1 year later, Novocure has a plenary session at ASCO24 for the Phase III METIS Trial. Stock is back on the way up!!!

So far, with the exception of Novocure's Press release and this tweet by Dr. Naidoo, there isn't much more information out there about the METIS trial.

Follow the Key Opinion Leader Discussions here at ASCO regarding this METIS trial.  Will it follow the LUNAR disappointment, or will METIS be a breakthrough in cancer care?

METIS Key Opinion Leader Sentiment Analysis

METIS Interactive AI CHATBOT 

Additional Sources:

LUNAR Trial Sentiment Analysis

LUNAR Trial Interactive AI Chatbot

Disclosure: The blog author is a graduate of Emory University's Goizueta Business School and an active donor to the university.