Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 475

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 475
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 a disease control rate of 53%, as measured by RECIST v1.1.

| ​                             | ​ |             ​ |   ​ |                 ​ |     ​ |
| ​                             | ​ |             ​ |   ​ | All Patients with |     ​ |
| ​                             | ​ | Patients with |   ​ |          Advanced |     ​ |
| ​                             | ​ |           HCC |   ​ |      Solid Tumors |     ​ |
| ​                             | ​ |         -N=17 |   ​ |             -N=41 |     ​ |
| ​                             |   |         n (%) |     |             n (%) |     ​ |
| Confirmed partial response(1) | ​ |             3 | -18 |                 5 | (12)* |
| Stable disease(2)             | ​ |             6 | -35 |                17 |   -41 |
| Progressive disease(3)        | ​ |             8 | -47 |                19 |   -46 |
| Disease Control Rate(4)       | ​ |            53 |   % |                54 |     % |
| Median Number of Therapies    | ​ |             2 |   ​ |               3.5 |     ​ |

Evaluable patients included patients with a follow-up on-study tumor assessment at least 42 days following cycle 1, day 1. *Two non-HCC patients demonstrated a confirmed partial response: one had ovarian cancer, the second had gastric cancer.

| (1) | Confirmed partial response (cPR), means at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |

| (2) | Stable disease means neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |

| (3) | Progressive disease means at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note that the appearance of one or more new lesions is also considered progression. |

| (4) | The disease control rate was calculated as the proportion of participants with a complete response, cPR, or SD, as