- The stock price of TCR2 Therapeutics Inc (NASDAQ: TCRR) fell by over 30% during intraday trading. This is why it happened.
The stock price of TCR2 Therapeutics Inc (NASDAQ: TCRR) – a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer – fell by over 30% during intraday trading. Investors are responding negatively to TCR2 Therapeutics announcing the results from the ongoing Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors. Even though the results were positive, investors were expecting a better ORR.
The dataset will also be featured in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021 on September 17 at 14:20 CEST (8:20 am EST) (Presentation #959O) and is part of the official ESMO Press Programme.
As of the June 30, 2021 data cutoff, 17 patients (12 mesothelioma, 4 ovarian cancer, and 1 cholangiocarcinoma) had received a single gavo-cel infusion in the dose-escalation portion of the gavo-cel Phase 1 clinical trial. And the median number of prior lines of therapy was 5, including immune checkpoint inhibitors (n=11) and mesothelin-directed therapies (n=5).
Gavo-cel was administered up to dose level 5 (DL5) (5×108/m2 following lymphodepletion). And two dose-limiting toxicities were reported: one Grade 3 pneumonitis at DL1 that resolved with supportive measures, which permitted the continuation of dose escalation, and one Grade 5 bronchoalveolar hemorrhage at DL5, which along with the development of severe CRS in all 3 patients treated at this dose level, led the Safety Review Team to declare 5×108/m2 as the MTD. Following identification of the MTD, one patient has received gavo-cel at 3×108/m2 after lymphodepletion using a split dosing approach to refine the RP2D and an additional patient has been treated at DL3 (1×108/m2 following lymphodepletion). In both cases gavo-cel was well tolerated with only Grade 1 non-hematological toxicities being reported.
15 of the 16 patients evaluable for efficacy experienced regression of their target lesions — ranging in magnitude from 5% to 75%. 6 patients achieved partial responses (PRs) by target lesion assessment, 4 of whom (3 with mesothelioma and 1 with ovarian cancer) achieved a PR according to RECIST 1.1 criteria, including one who also achieved a complete metabolic response. One patient with cholangiocarcinoma was also considered to have achieved a PR by investigator assessment, for an objective response rate of 31%. By independent review assessment, the objective response rate was 25% with a DCR Rate of 81%. The median overall survival for patients with mesothelioma is 11.2 months, whereas the median progression-free survival is 5.9 months.
The primary objectives of the Phase 1 portion of the trial are to define the safety profile of gavo-cel in patients whose tumors overexpress mesothelin and to determine the RP2D. And secondary objectives include ORR and DCR. Exploratory objectives include the assessment of expansion, tumor infiltration, and persistence of gavo-cel.
“The interim gavo-cel data reported today showed continued clinical benefit and a manageable safety profile in a population of patients that previously achieved minimal or no improvement due to the advanced and aggressive state of their cancer. Patients with treatment refractory cancer have very limited treatment options and will often need hospice and supportive care. We are encouraged by the early survival data from gavo-cel in patients previously treated with checkpoint inhibitors and other therapies.”
— Principal investigator David Hong, M.D., deputy chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center
“Our ambition with gavo-cel from the start was to redefine treatment for solid tumors with cell therapies. We are excited to present data demonstrating clinical activity in all three mesothelin-expressing solid tumors treated to date and tumor regression in a majority of patients who are treatment refractory after numerous lines of therapy. We are very encouraged by the progression free survival and overall survival observed among patients with refractory mesothelioma treated so far with gavo-cel in the Phase 1 trial. Based on these data and the most recent patient experiencing a very mild safety profile at a cell dose of 3×108/m2, we believe the identification of the RP2D is close at hand. As we approach the Phase 2 expansion phase, our focus will shift to further optimizing outcomes for patients by studying combinations with immune checkpoint inhibitors, allowing gavo-cel re-treatment and evaluating different mesothelin expression thresholds.”
— Alfonso Quintás-Cardama, M.D., Chief Medical Officer of TCR2 Therapeutics
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