The Maintenance Vigil I / O shows its effectiveness in the treatment of advanced ovarian cancer with competence in HRD

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Rodney P. Rocconi, MD, a gynecologic oncologist, associate director for clinical research and professor of interdisciplinary clinical oncology, at USA Health, discusses a subgroup analysis of the phase 2b VITAL study in which the Efficacy of Vigil maintenance immunotherapy is explored in patients with newly diagnosed advanced ovarian cancer who is competent in homologous recombination.

Subgroup analysis revealed that patients with stage III / IV ovarian cancer obtained clinical benefit from first-line maintenance of Vigil immunotherapy and that the treatment was well tolerated. A benefit was also observed in patients with BRCA positive wild type tumor.

Overall, the subgroup analysis suggests that this subgroup of patients are very sensitive to Vigil therapy, according to Rocconi.

Transcription:

0:08 | We basically presented the updated efficacy results of first-line ovarian cancer maintenance therapy and GEM, which is an immune vaccine, and we examined a subset of patients with ovarian cancer. homologous recombination competent ovarian cancer. We presented updated data as well as a translational evaluation for biomarkers predictive of response.

0:38 | Thus, in the original publication, the primary endpoint, which was recurrence-free survival in all patients, showed a trend in favor of recurrence-free survival, but was not statistically significant with a P value of 0.078. As expected in part of this presentation of this summary, we examined competence in homologous recombination, as it appeared to have an enhanced response, while being a very tolerable agent.

1:16 | This study is a randomized, double-blind, placebo-controlled Phase 2b study comparing GEM to placebo in a 1: 1 fashion. To be eligible, patients had to have advanced epithelial ovarian cancer. , either stage III or IV, and have undergone primary surgical treatment, plus platinum taxane chemotherapy and achieve a complete clinical response. At this point, the patients were then randomized 1 to 1. The vaccine and placebo were given intradermally once a month, from anywhere based on 4 to 12 cycles, which was determined by the amount of active vaccine created. And again, our primary endpoint was recurrence-free survival and the secondary endpoints were overall survival in subgroup analysis based on BRCA mutations as well as homologous recombination status.

2:19 | In these updated data of competent patients in homologous recombination, 25 patients received the GEM vaccine and 20 placebo groups were similar for all demographic and pathological variables. This was a well-tolerated agent, for which there were essentially no Grade 3 or 4 adverse events, and the majority of adverse events were mild, with skin irritation at the injection site being severe. most common adverse event. Furthermore, these were equal between the placebo in the GEM groups.

2:54 | From the point of view of efficacy and competence in homologous recombination, we have seen very encouraging results with the statistical improvement in both the recurrence-free survival benefit from 5.7 to 10.6 months, which is correlated a 61% reduction in recurrence, as well as an improvement in survival benefit from 26.9 months in the placebo to an unachieved median in the GEM arm, corresponding to a 66% reduction in deaths .

3:25 | Looking at our long-term data, which represents a median of 58 months of follow-up, which was analyzed through April 2021, this overall survival advantage has been maintained. The two-year overall survival was 92% in the GEM arms versus 55 in the placebo group, and the 3-year overall survival was 70% in the GEM arm versus 40% in the placebo arm. Both were statistically significant. I mentioned some of the final points of the translation. We examined the gene-protein interactions and protein-protein using a large database[labasededonnéesStringEtenanalysantcelasurlabasedel’analyseinformatiquedesprotéinesapparentéesàlarecherched’unesortedesous-groupemoléculairedepatientspourprédirelameilleureréponsel’ensembledeprotéinescompétentesenrecombinaisonhomologueavecl’ensembledeprotéinesp53adonnélesrésultatslesplusfavorablesoùlarécurrence-lasurviesanseffetétaitde56dansleplacebocontre21moisdanslegroupeGEMEtlasurvieglobaleencoreunefoisaétémaintenueavecunavantagesignificatifdanscetteanalysedesous-groupeégalementC’étaitdonctrèsprometteurnonseulementpournotresuiviprolongéavecunsuiviimmédiatànouveaude58moismaisaussipournospointsfinauxdetraductionainsiquenousessayonsdenousconcentrersurdesbiomarqueursprédictifsquipourraientêtreutilesàl’avenir[theStringdatabaseAndbyanalyzingthatbasedonthecomputationalanalysisofrelatedproteinslookingforkindofamolecularsubgroupofpatientstopredictthebestresponsethehomologousrecombinationproficientsetofproteinswithp53setofproteinsgavethemostfavorableoutcomeswheretherecurrence-freesurvivalwas56intheplacebocomparedto21monthsintheGEMgroupAndtheoverallsurvivalagainwasmaintainedwithasignificantbenefitinthatsubgroupanalysisaswellSoitwasverypromisingnotonlyfromourextendedfollowupwithimmediatefollowupagainof58monthsbutinourtranslationalendpointsaswellaswetrytohomeinonpredictivebiomarkersthatcouldbeofuseinthefuture[labasededonnéesStringEtenanalysantcelasurlabasedel’analyseinformatiquedesprotéinesapparentéesàlarecherched’unesortedesous-groupemoléculairedepatientspourprédirelameilleureréponsel’ensembledeprotéinescompétentesenrecombinaisonhomologueavecl’ensembledeprotéinesp53adonnélesrésultatslesplusfavorablesoùlarécurrence-lasurviesanseffetétaitde56dansleplacebocontre21moisdanslegroupeGEMEtlasurvieglobaleencoreunefoisaétémaintenueavecunavantagesignificatifdanscetteanalysedesous-groupeégalementC’étaitdonctrèsprometteurnonseulementpournotresuiviprolongéavecunsuiviimmédiatànouveaude58moismaisaussipournospointsfinauxdetraductionainsiquenousessayonsdenousconcentrersurdesbiomarqueursprédictifsquipourraientêtreutilesàl’avenir[theStringdatabaseAndbyanalyzingthatbasedonthecomputationalanalysisofrelatedproteinslookingforkindofamolecularsubgroupofpatientstopredictthebestresponsethehomologousrecombinationproficientsetofproteinswithp53setofproteinsgavethemostfavorableoutcomeswheretherecurrence-freesurvivalwas56intheplacebocomparedto21monthsintheGEMgroupAndtheoverallsurvivalagainwasmaintainedwithasignificantbenefitinthatsubgroupanalysisaswellSoitwasverypromisingnotonlyfromourextendedfollowupwithimmediatefollowupagainof58monthsbutinourtranslationalendpointsaswellaswetrytohomeinonpredictivebiomarkersthatcouldbeofuseinthefuture


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