The summer oncology conferences are drawing nearer, and so to is the abstract release date for ASCO. For a complete overview of the timeline and abstract titles I am watching, check out my previous piece: ASCO Alert: Stay Ahead of the Updates. These past few trading session have been overshadowed by trade war fears and volatility. One small cap oncology company that has been hit extremely hard is TG Therapeutics (TGTX). Since May 7th, TGTX has dropped just over 20% from its top to bottom. This is ahead of a potential catalyst, the ASCO abstract release at 17:00 EST on May 15th. For a complete overview on TG, check out my piece: An-In-Depth Assessment of TG Therapeutics.
But what do I have my eye on? TGTX has been awarded an oral presentation on June 4th titled: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open label, registration directed phase II study (Abstract: 7506). At AACR in April, TGTX gave a podium presentation on the interim data, which consisted on data on 42 of the 69 patients enrolled and treated. These results were very encouraging, and can be viewed here.
These 42 patients were analyzed as they have had follow up for at least nine months. For your reference, enrollment was completed in this trial in August of 2018. The interim data was the basis for the FDA granting TGTX’s umbralisib Breakthrough Therapy Designation for Marginal Zone Lymphoma. Based on the information available, we are unable to determine what the data cutoff was for the interim analysis and data presented at AACR.
What we do know is this:
- TGTX has already met their target overall response rate (ORR) of 40-50% when analyzing all 69 patients treated
- The ORR data (52%) presented at AACR was only for the first 42 patients, meaning the ORR could go up or down based the responses of the remaining patients as they progress through follow-up
- The interim ORR and safety analysis for the entire 69 patient cohort has been completed, but has yet to be presented
I speculate that based on the title of the abstract and the above listed facts, data from the entire cohort will be presented at ASCO. Based on the timelines, it would be very close for TGTX to have all patients complete 9 months of therapy, the data cleaned, and prepared for presentation at ASCO, but this could be a possibility. However, I am managing my expectations, but do expect to see new data at ASCO from this larger cohort. The fact that TGTX was awarded a podium presentation over a poster presentation further points to notable data being discussed. If the data has continued to mature, and the patients not in the original 42 patients presented on at AACR show good response rates, the ORR could increase from the 52% previously announced. At the same point, the ORR could slightly dip down, but we know the ORR for the entire cohort is at least 40%.
What has management said about this? Well, they have been difficult to read. What they have said is this:
“While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted later this year once all treated patients have had at least 9 cycles (Cycle = 28 days) of follow-up.”
And also this:
“We are highly encouraged by the interim results presented thus far for the MZL cohort of the UNITY-NHL trial and we look forward to presenting final data from this cohort later this year and to discussing the results with the FDA with the goal of filing for accelerated approval of umbralisib by year-end.”
This confirms that the full data set will be presented at a conference this year, but not exactly when. If not at ASCO, ESMO and ASH are other options, but I tend to believe ASH is too late in the year (December) for this data to be presented, especially seeing as plans to meet with the FDA and file for accelerated approval before the end of the year. Therefore, we may see this data at ASCO, will know more when abstracts are released tomorrow. Typically, ASCO abstracts contain a good amount of data that will be presented, and are not vaguely written as done for other conferences. Furthermore, TGTX would be unable to “repeat” their AACR presentation, as such an abstract would not be accepted.
As such, the abstract release could prove to be a catalyst. If the full data is reported and the ORR has improved, this could lend more excitement to this candidate and TGTX’s future success. Should the results not meet expectations, there may be a small sell-off, but I am confident in TGTX long-term prospects, and such price action would not worry me. TGTX has many irons in the fire and shots on goal in the next 12 months, as discussed in my aforementioned overview of TGTX.
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I/we LONG TGTX.
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