Tempest’s PPAR-α antagonist offered a lifeline for patients with unresectable or metastatic hepatocellular carcinoma when added onto two Roche drugs in a phase 1/2 trial.
The new data presented Wednesday confirmed a 30% objective response rate (ORR) among patients who received TPST-1120 in addition to Roche’s Avastin and Tecentriq compared to a 13.3% ORR among the control arm who received the latter two approved treatments.
Tempest found that median progression-free survival among patients receiving the triplet treatment was seven months compared to 4.27 months for those on the double combo. Median overall survival was not reached in the group receiving TPST-1120 and was 15.1 months for the control arm. The hazard ratios were 0.7 and 0.59 for progression-free survival and overall survival, respectively.
The new figures include 40 patients who received Tempest’s triplet treatment with a median follow-up of 9.2 months and 30 patients given the double combo with a median follow-up of 9.9 months. Tempest said the triplet was shown to be well-tolerated and that safety data were “comparable” between the two arms.
The data validate the early readout teased in late April when the response rate was unconfirmed. CEO Stephen Brady said in today’s release that Tempest is now gearing up to move the triplet therapy into a pivotal trial. The company’s shares moved out of the red, from less than a quarter per share to $2.02 shortly after the market opened.
Tempest is also testing TPST-1120 in other solid tumors, seeing how widely applicable blocking the peroxisome proliferator-activated receptors can be in treating cancer. The receptors help regulate fatty acids, and previous research indicated that targeting them could help treat metabolic diseases.
The biotech’s runner-up asset, TPST-1495, is an EP2/4 antagonist also aimed at multiple solid tumors, including a standalone trial to treat patients with endometrial cancer when combined with an alpha PD-1 treatment.