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Microbes & Immunity                                                Factors associated with response to T-VEC




            Table 4. Patient characteristics and overall survival (OS)  Table 4. (Continued)
            Variable                       Death (%)  P‑value  Variable                       Death (%)  P‑value
            Categorical variables a                             No                                 20
             Total                                   3  1.00   Number of prior lines of
            Sex                                                immunotherapy
             Male                                    2  1.00    0                                  20   0.006
             Female                                  1          1                                  0
            Race                                                2                                  100
             Caucasian                               3         Concurrent immunotherapy
                                                               and T-VEC
             Other                                   -
                                                                Yes                                15     1.00
            Breslow categorical
                                                                No                                 20
             <1 mm                            33      0.06     Infield response (complete
             1.01 – 2 mm                             0         or partial)
             2.01 – 4 mm                      67                Yes                                14     1.00
             >4 mm                                   0          No                                 25
            Stage at T-VEC initiation                          Bystander response
             IIIB                                    0  0.10    Yes                                0      0.05
             IIIC                                    0          No                                 50
             IIID                                    0          N/A                                0
             IV                               50               Continuous variables a  Died     Alive
            BRAF mutation                                                           (Mean [SD])  (Mean [SD])
             Mutant                           40      0.17     Age at T-VEC injections (years)      80 (10)       70 (9)     0.11
             Wild-type                               8         Breslow depth (mm)     2.6 (1.5)  5.7 (3.7)     0.18
            NRAS mutation                                      Number of cycles of T-VEC  4.3 (1.2)  6.8 (3.9)     0.30
                                                                   a
             Mutant                           14      1.00     Note:  Fisher’s exact tests for categorical variables, two-sample t-tests
                                                               for continuous variables.
             Wild-type                        18
                                                               Abbreviation: T-VEC: Talimogene laherparepvec.
            Injection location
             Head and neck                    17      1.00     combining systemic targeted therapies with checkpoint
             Upper extremity                         0  1.00   blockade. 21
             Torso                            20      1.00       Another significant area of research lies in investigating
             Lower extremity                  13      1.00     the concurrent or sequential administration of ICI. Chesney
                                                                  22
            Type of lesion injected                            et al.  reported in their 2019 study that patients treated with
             Skin                                    0  1.00   ipilimumab + T-VEC exhibited a greater overall response
                                                               and visceral organ response rate compared to ipilimumab
             Soft tissue                      23      0.52
             Lymph node                              0  1.00   alone, although the majority of patients in both treatment
                                                                                                  23
            Number of treated lesions                          arms did not respond at all. Malvehy et al.  indicated an
                                                               increase in CD8+ T-cell density in non-injected T-VEC
             1                                25      0.65     sites, suggesting that T-VEC therapy may enhance the
             2                                11               effectiveness of immunotherapy. In addition, Ribas et al.
                                                                                                             5
             ≥3                                      0         reported a phase 1 trial of T-VEC injection followed by
            Prior systemic therapy                             concurrent T-VEC and pembrolizumab, demonstrating
             Yes                              15      1.00     safety and an ORR of 61.9%. While these studies hinted
                                                               at the potential of T-VEC treatment in combination with
             No                               20
            Prior immunotherapy                                immunotherapy, the results of the phase III randomized
                                                               trial combining T-VEC with pembrolizumab failed to show
             Yes                              15      1.00     a statistically significant improvement in progression-free
                                                                           4
                                                    (Cont'd...)   survival or OS.  In our current study, 72% of our patients


            Volume 1 Issue 1 (2024)                        102                               doi: 10.36922/mi.3445
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