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  • 1
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    Phase II trial of CV301 vaccine combined with atezolizumab in advanced urothelial carcinoma
    Springer Science and Business Media LLC ; 2023
    In:  Cancer Immunology, Immunotherapy Vol. 72, No. 3 ( 2023-03), p. 775-782
    Details
    In: Cancer Immunology, Immunotherapy, Springer Science and Business Media LLC, Vol. 72, No. 3 ( 2023-03), p. 775-782
    Type of Medium: Online Resource
    ISSN: 0340-7004 , 1432-0851
    URL: Article
    DOI: 10.1007/s00262-022-03274-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 1458489-X
    detail.hit.zdb_id: 195342-4
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  • 2
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    Changes in body composition during neoadjuvant platinum-based chemotherapy associations prior to radical cystectomy: Implications for chemotherapy-associated adverse events and oncologic outcomes.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 476-476
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 476-476
    Abstract: 476 Background: Low skeletal muscle index (SMI) is associated with an increased risk of mortality in muscle-invasive bladder cancer (MIBC) and chemotherapy-related adverse events (AE) across numerous other malignancies. Small case series suggest neoadjuvant chemotherapy (NAC) is associated with a significant decline in SMI in patients with MIBC. However, limited data exists regarding changes in fat mass during NAC. Herein, we examine changes in SMI, visceral fat index (VFI), and subcutaneous fat index (SFI) in patients receiving NAC for MIBC before radical cystectomy (RC). We describe associations between body composition changes and NAC-associated AE and all-cause mortality (ACM) in patients with MIBC. Methods: Retrospective review of patients with MIBC (≥pT2 N0/x/1 M0) who received NAC (2006-2019). Patients with digitized abdominal computed tomography scans (CT) within 75 days prior (T1) and 75 days following completion (T2) of NAC were included. We segmented and calculated the indices (cm 2 /m 2 ) for SMI, VFI, and SFI at the third lumbar vertebra level at T1 and T2 using validated methodology. Associations with AE during NAC and ACM were evaluated with multivariate logistic regression and Cox proportional hazards models. Results: Included 170 patients, median age 63 years receiving a median of 4 (IQR 3-5) cycles of Gemcitabine/Cisplatin (52%), MVAC (28%), or other NAC (20%). Absolute and relative changes in SMI, VFI, and SFI over a median of 112 days (IQR 94-146) between measurements are presented in the Table. 117 (69%) patients experienced grade ≥3 chemotherapy-related AE. No associations between baseline body composition or change in body composition during NAC with chemotherapy-related AE. T1 SMI (HR: 0.98; 0.97-0.99, p = 0.008), as well as T2 SMI (HR: 0.98; 0.96-0.99, p = 0.003), T2 VFI (HR: 0.99; 0.99-1.0, p = 0.05) and T2 SFI (HR: 0.99; 0.98-1.0, P = 0.03) were associated with ACM after adjusting for age, clinical T and N stage, and performance status. Conclusions: Patients undergoing NAC prior to RC experienced a 6.4% decrease in SMI and a 5.2% decrease in VFI during an average of 112 days. Chemotherapy-related AE were not associated with a change in body composition. Baseline SMI and T2 SMI, SFI, and VFI were associated with ACM on multivariable analysis. Future work is needed to understand the mechanisms underpinning such changes and the extent to which potentially detrimental changes in body composition may be mitigated before surgery.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.476
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Patient (pt) characteristics, treatment patterns, outcomes and prognostic factors in plasmacytoid urothelial carcinoma (PUC).
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e16007-e16007
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e16007-e16007
    Abstract: e16007 Background: PUC is uncommon and highly aggressive, with limited data on treatment patterns, outcomes and prognostic factors. We hypothesized that PUC is associated with clinical under-staging, poor outcomes and lack of chemotherapy (CT) response. Methods: We conducted a retrospective review of pts with UC and plasmacytoid component (PUC), seen in our institution (2000 - 2018). Demographic and clinicopathologic data, treatment modalities, pathologic complete/partial response (pCR, pPR) to neoadjuvant CT (NAC), and overall survival (OS) from diagnosis and surgery (Sx) were captured. T-test, chi-square, and Cox-regression were used to explore potential prognostic associations. OS was estimated with KM method. Results: We identified 63 consecutive pts (51 men) with available data for analysis. Median age at diagnosis was 67 (44-89). During initial diagnostic workup, 32 (51%) pts had extravesical disease (cT3:24, cT4:8) and 23 (36.5%) hydronephrosis at imaging. Overall, 39 (62%) pts underwent Sx with curative intent, 25 (39.6%) were pre-treated with cisplatin-based NAC; adjuvant CT was given to 15 (24%). The remaining pts pursued bladder-sparing and/or palliative approaches. At time of Sx, 17/39 (43.6%) pts had pathologic upstaging, 10 (25.6%) had positive margins and 19 (48.7%) pN+ stage. In the NAC pt subset (25 pts), 5 (20%) had progression on scans, 19 (76%) had Sx; 2 pts had pCR (10.5%), 1 had pPR, 6 (31.5%) had pathologic upstaging. In the entire cohort, median follow-up was 8 months. Median OS was 20.7 months from diagnosis and 23.6 months from Sx. NAC was not significantly associated with longer OS (from Sx) (HR 1.53, 95%CI 0.16-15, p = 0.715) and the same was true for adjuvant CT (HR 0.64, 95%CI 0.1-4, p = 0.630). 15/39 pts recurred after Sx (38.4%), with 9/15 (60%) having peritoneal/retroperitoneal involvement. Conclusions: PUC frequently presented with advanced stage at diagnosis and demonstrated poor NAC response, frequent upstaging, positive margins and pN+ stage at Sx. More than half of patients who recurred after Sx, presented with (retro)peritoneal disease. Studies evaluating molecular biomarkers and drivers in PUC, and prospective clinical trials are being pursued.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e16007
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 4
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    Distinct genomic hallmarks exist between metastatic upper and lower tract urothelial carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 7_suppl ( 2019-03-01), p. 371-371
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 7_suppl ( 2019-03-01), p. 371-371
    Abstract: 371 Background: Although the genomic landscape of LTUC is well studied, less is known about UTUC, including in the metastatic sites. We compared genomic features of metastatic UTUC and LTUC. Methods: We performed whole exome sequencing on 7 rapid autopsy patients with metastatic UC, with matched primary and metastatic tumor samples (N = 37). Single nucleotide variants (SNV) were identified using Mutect and Strelka. Focused analyses were performed on mutations with known significance in UC as well as mutations predicted to have functional impact using 11 mutation assessors. Genome scale copy number aberrations (CNA) were estimated using Sequenza (normalized for ploidy) to derive gene definition restricted copy number estimation outcomes. Multi-dimensional scaling (MDS) was used to visualize how copy number and mutation-derived genomic distances differed between LTUC and UTUC. Results: Three pts with UTUC (3 primary samples, 13 metastases) and four pts with LTUC (4 primary samples, 17 metastases) were examined. The majority of patients were male (5) and received cisplatin-based therapy (5). We found that SNV burden (mean mutation per megabase) was significantly higher in LTUC vs. UTUC overall (6.6 vs. 3.8, p = 0.001) and when stratified by primaries (6.1 vs. 2.9, p = 0.047); or metastases (6.7 vs. 4.1, p = 0.001). Mutational signature analysis revealed higher proportion of APOBEC signature in all LTUC vs. UTUC tumors. Both inter- and intra-individual genomic distances between primary and metastatic tissues were substantially larger in UTUC than LTUC, suggesting a wider spectrum of mutations at the level of individual nucleotides and chromosomal structure. Interestingly, Gene definition-restricted CNA analysis revealed MDM2 amplification exclusively in UTUC tumors which was associated with shallow p53 deletion. Conclusions: Metastatic UTUC appears to have a lower overall mutational burden but greater genomic variability compared to LTUC. Our relatively small dataset suggests that metastatic UTUC displays a greater spectrum of mutational divergence from LTUC which may partially explain differences in clinical behavior.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.7_suppl.371
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
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  • 5
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    Activity of abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) previously treated with ketoconazole (keto): A prospective phase II study from the Prostate Cancer Clinical Trials Consortium.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 15_suppl ( 2014-05-20), p. 5039-5039
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 5039-5039
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.15_suppl.5039
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
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  • 6
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    Activity of abiraterone acetate in metastatic patients with castration-resistant prostate cancer (mCRPC) previously treated with ketoconazole: A prospective phase II study from the prostate cancer clinical trials consortium.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 4_suppl ( 2014-02-01), p. 53-53
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 4_suppl ( 2014-02-01), p. 53-53
    Abstract: 53 Background: Abiraterone acetate (AA), like ketoconazole (keto), inhibits CYP17, the rate-limiting enzyme in androgen biosynthesis. Since patients (pts) with prior keto treatment were excluded from the pivotal phase III AA trials, the utility of AA after keto is not well understood. This prospective study evaluated the efficacy of AA in pts who had received prior keto. Methods: Pts with progressive castration-resistant prostate cancer (mCRPC), prior keto therapy 28 days or more, and normal baseline organ function (including ACTH stimulation) tests were treated with AA 1,000 mg PO daily and prednisone 5 mg PO BID. Pts with prior chemotherapy were excluded. Serum androgen levels, including dehydroepiandrosterone (DHEA), were measured by liquid chromatography/mass spectroscopy (LC/MS) at baseline and during treatment for exploratory analyses. Radiographic progression-free survival (rPFS) was defined as freedom from: death, radiographic progression, or unequivocal clinical progression. Results: Forty two pts were enrolled. Median age was 71. Median prostate-specific antigen (PSA) was 47.5ng/dL. Median duration of prior keto was 38 weeks (range 5 to 207). Treatment with AA resulted in 30% or greater decline in PSA at 12 weeks in 20 pts (48%, 95% CI, 32-63%), and 50% or greater decline in PSA at 12 weeks in 16 pts (38%, 95% CI 24-54%). Median time to PSA progression (TTPP) was 16 weeks (range 4 to 64). Median rPFS was 24 weeks (range 1 to 88). Baseline serum DHEA levels were measured in 40 pts. Nine pts had DHEA less than the limit of quantitation (LOQ, 0.250ng/mL), and 31 pts had DHEA greater than or equal to LOQ. One pt with DHEA less than LOQ (1 out of 9, 11%, 95% CI 0.6-49%) had PSA decline 30% or more at 12 weeks, compared to 17 pts (17 out of 31, 55%, 95% CI 36-72%) with DHEA greater than or equal to LOQ (p=0.028). Median time to pain progression (TTPP) was 8 weeks (range 4 to 32) for pts with DHEA less than LOQ, compared to 18 weeks (range 4 to 64) for pts with DHEA greater than or equal to LOQ (p=0.012). Median rPFS was 12 weeks (range 4 to 24) for pts with DHEA less than LOQ, compared to 36 weeks (range 1 to 88) for pts with DHEA greater tha or equal to LOQ (p = 0.0006). Six pts remain on AA. Conclusions: A significant proportion of pts with prior keto exposure demonstrate clinical response to AA. DHEA levels via LC/MS merits further study as a predictive biomarker in pts treated with androgen synthesis inhibitors. Clinical trial information: NCT01199146.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.4_suppl.53
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 7
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    Perioperative blood transfusion and postoperative outcomes in patients undergoing radical cystectomy for bladder cancer.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e17012-e17012
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e17012-e17012
    Abstract: e17012 Background: Perioperative blood transfusion (PBT) has been associated with worse outcomes in surgical oncology across tumor types. We report our institutional experience of postoperative outcomes related to PBT utilization, in patients (pts) with bladder cancer (BC) treated with radical cystectomy (RC). We hypothesized that PBT is associated with worse clinical outcomes. Methods: Pts with BC treated with RC were retrospectively identified. Clinicopathologic and peri/post-operative data were extracted. PBT was defined as red blood cell transfusion during RC or postoperative hospitalization. Overall survival (OS, diagnosis to death) and recurrence free survival (RFS, RC to recurrence/death) were estimated with the KM method. T-test, χ 2 and log-rank test were used for group comparison analysis. Univariate/multivariate logistic (LR) and Cox regression (CR) were used to identify variables associated with dependent dichotomous outcomes and OS/RFS, respectively. Results: 784 consecutive pts (78% men; median age 67) were identified. At least one post-operative complication (POC) occurred in 407 (52%) pts; most common were pyelonephritis and sepsis (11% each). PBT was administered to 238 pts (30%). Those with PBT had a higher proportion of POCs (35% vs 28%, p = .02). Median follow-up, OS and RFS were 66 (95% CI: 60 - 72), 94 (95% CI: 79 - 109) and 66 months (95% CI: 50 – 82), respectively. Pts who received PBT had shorter OS (51 vs 130 months, p 〈 .001) and RFS (27 vs 86 months, p 〈 .001). In multivariate LR and CR, PBT was independently associated with higher odds of POCs (OR 1.5, 95% CI: 1.03 – 2.2, p = .03), length of hospital stay (LOS) 〉 10 days (OR 2.0, 95% CI 1.1 – 3.5, p = .02), shorter OS (HR 1.6, 95% CI 1.2-2.0, p = .001), and RFS (HR 1.5, 95% CI 1.2 - 1.9, p = .001), after adjustment for other relevant clinicopathologic variables (age, gender, performance status, neoadjuvant chemotherapy, baseline hemoglobin, open/robotic approach, pT/N stage, surgical margins, lymphovascular invasion at RC, variant histologies). Conclusions: Pts who received PBT had higher odds of POC, longer LOS and poor outcomes after RC. This is hypothesis-generating due to inherent study limitations. Further studies are needed to validate this finding, explain underlying mechanisms and explore putative interventions to improve outcomes.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e17012
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Skeletal muscle index and adverse events during a bladder cancer treatment episode.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e17016-e17016
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e17016-e17016
    Abstract: e17016 Background: While sarcopenia is associated with increased mortality in bladder cancer, there is limited data in patients treated with neoadjuvant chemotherapy (NAC) that associates skeletal muscle index (SMI) and adverse treatment-associated outcomes. Herein, we evaluate associations between baseline SMI and severe adverse events (SAEs) during NAC and post-radical cystectomy (RC) 90-day Clavien ≥3 complications. Methods: SMI (cross sectional area of skeletal muscle, cm 2 / height 2 , m 2 ) was measured on an axial computed tomography (CT) image at the level of the third lumbar vertebral body, within 60 days prior to NAC and RC. Patients were classified as being sarcopenic, according to sex-specific consensus definitions: Male: SMI 〈 55, Female: SMI 〈 39. Associations with SAEs during NAC and 90-day Clavien grade 3-5 complications were assessed with multivariable logistic regression. Results: CT scans of sufficient quality (2005-18) were available for 143 patients. There were no significant differences in clinicopathologic characteristics between the study cohort and patients without available imaging (N = 261). Median SMI for men and women was 52.1 and 40.9 cm 2 /m 2 ; 86 (60%) were sarcopenic. SAEs were observed in 92 patients (64%), resulting in hospitalization during NAC in 27 (19%), while 20 (14%) patients did not complete planned NAC due to SAEs. After adjusting for age, performance status, and clinical stage, SMI was not independently associated with NAC-associated SAEs. Postoperative complications occurred in 82 (57%) patients, including infectious complications (39; 27%), wound dehiscence (8; 6%), 90-day readmission (27; 19%). Wound healing complications including dehiscence, clinically significant hernia, urine leaks, or fistulae occurred in 33 (23%). While SMI was not independently associated with risk of complications overall (OR: 1.00, 95% CI: 0.96 - 1.03), it was associated with infectious complications (OR: 0.96, 95% CI: 0.92 - 0.99, p = 0.02), and wound dehiscence (OR: 0.93, 95% CI: 0.86 - 0.99, p = 0.02) with a trend towards significance for associations with any wound-healing complications (OR: 0.96, 95% CI: 0.91 - 1.00, p = 0.08). Conclusions: In the largest reported series of post-NAC patients with RC and detailed follow-up, pretreatment SMI was not associated with SAEs during NAC but was associated with serious infectious complications and wound dehiscence after RC. This data highlights the potential value in measuring SMI to identify patients at risk for select SAEs. Future studies should assess the benefit of prehabilitation before and during NAC.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e17016
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Sarcomatoid urothelial carcinoma: Oncologic outcomes from a tertiary center and SEER-Medicare data.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e17033-e17033
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e17033-e17033
    Abstract: e17033 Background: Sarcomatoid urothelial carcinoma (SUC) is a rare and aggressive bladder cancer variant with little evidence regarding prognostic characteristics and response to neoadjuvant chemotherapy (NAC). In this study, we delineate oncologic outcomes in patients with SUC after radical cystectomy (RC), presenting data from our institutional database and SEER-Medicare. Methods: We retrospectively queried our institutional database to identify consecutive patients with cT2-4 SUC and conventional (non-variant) UC (CUC) who underwent RC (2003-2018). SEER-Medicare database was also searched for patients with cT2-4 SUC (2004-2015). Clinicopathologic/treatment data were captured. Overall survival (OS – diagnosis to death) was estimated with the Kaplan-Meier method. T-test, χ 2 test and log-rank test were used for group comparison analysis. Factors significant in univariate analysis for OS were included in the multivariate (MVA) Cox proportional hazards model. Results: Institutional RC database yielded 38 patients with SUC and 287 with CUC, while 190 patients with SUC were identified from SEER-Medicare [83 (44%) had RC] . Platinum-based NAC was given to 17/38 (45%), 162/287 (56%) and 26/83 (31%) patients, respectively. Institutional patients with SUC had significantly higher rates of pT3/4 disease at RC (66% vs. 35%, p 〈 .001) and lower rates of complete pathologic response (ypT0N0) following NAC (6% vs 35%, p = .02). Median OS in patients who had RC was significantly inferior in our institutional SUC vs. CUC group (20 vs. 121 months, p 〈 .001) and 21 months in the SEER-SUC cohort. No significant difference in OS was identified between NAC+RC vs. RC alone, both in the institutional (17 vs. 20 months, p = 0.66) and SEER-SUC cohort (24 vs. 20 months, p = 0.56). In MVA for the entire institutional cohort (SUC+CUC combined), SUC was independently associated with worse OS, when adjusted for advanced age, pT/N stage, performance status, NAC, lymphovascular invasion, surgical margins (HR, 95% CI: 2.3, 1.4 - 3.8, p = .001). Five patients had an abdomino-pelvic cystic recurrence, with median time to recurrence 〈 5 months. Conclusions: Patients with SUC treated with RC had high rates of extravesical extension, poor response to platinum-based NAC and worse OS compared to patients with CUC. Data from SEER showed a comparable OS to our SUC cohort. NAC was not associated with improved OS in any SUC cohort (institutional or SEER). A unique pattern of rapid abdomino-pelvic cystic recurrence, mimicking post-RC abdominal fluid collections, was also identified.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e17033
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Phase 2 trial of CV301 vaccine plus atezolizumab (Atezo) in advanced urothelial carcinoma (aUC).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 511-511
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 511-511
    Abstract: 511 Background: PD(L)1 inhibitors can achieve durable responses in aUC but only in a minority of patients (pts). Combination strategies with agents that “prime and stimulate” the immune system may improve outcomes. CV301 comprises 2 recombinant poxviruses, Modified Vaccinia Ankara (MVA) and Fowlpox (FPV), encoding the human transgenes for CEA, MUC-1, and a Triad of Co-stimulatory Molecules (TRICOM: ICAM-1, LFA-3, and B7-1). MVA-CV301 is used for priming and FPV-CV301 is used for booster doses. Preliminarily, BN-platform vaccine plus PD-(L)1 inhibitors exhibited synergistic preclinical anti-tumor efficacy and the combination of CV301 and anti-PD-(L)1 agent demonstrated an acceptable safety profile. We hypothesized that this combination would be safe and effective in cisplatin-ineligible or platinum-refractory pts with aUC. Methods: A Phase 2, single-arm multicenter trial was designed to study CV301 + atezo as 1st-line treatment in pts with aUC ineligible for cisplatin-based chemotherapy regardless of PD-L1 status (Cohort 1; C1) and in pts progressing on/after platinum-based chemotherapy (Cohort 2; C2). MVA-CV301 was given subcutaneously (SC) on Days 1 and 22 and FPV-CV301 SC from day 43 every 21 days for 4 doses, then every 6 weeks until 6 months, then every 12 weeks until 2 years. Atezo 1200mg IV was given every 21 days. Primary endpoint: objective response rate (ORR). Secondary endpoints: OS, PFS, response duration, AEs and antigen-specific T-cell responses to CEA and MUC-1 by ELISPOT. Using 1-sided α 2.5%/cohort, a 2-stage design with 14/19 and 13/22 stage 1/2 subjects, respectively, will achieve ≥70% power if the true ORR for C1 is 43% and C2 is 33%. 3 C1 and 2 C2 responders were required in stage 1 to move forward. Results: 43 evaluable pts were enrolled and received therapy: 19 in C1; 24 in C 2. Overall, 9 pts experienced ≥ Grade 3 AEs related to the combination of treatment: 5 in C1, and 4 in C2. In C1, 1 pt had partial response (PR), for ORR 5.3% (90%CI: 0.3, 22.6) and 5 (26.3%, 90%CI: 11.0, 47.6) had stable disease (SD) as best response. In C2, 1pt had CR and 1 had PR, for ORR 8.3% (90%CI: 1.5, 24.0) and 3 (12.5%, 90%CI: 3.5, 29.2) had SD as best response. Median PFS and OS in C1 were 2.0 mo and 13.8 mo, and in C2 1.95 and 8.13 mo, respectively. The trial was halted for futility. Responding pts in C2 exhibited T-cell responses to CEA and pts with SD exhibited responses to MUC-1. Conclusions: CV301 + atezo exhibited an acceptable safety profile but did not demonstrate sufficient efficacy in pts with aUC as 1st-line therapy in cisplatin-ineligible pts or in the platinum-refractory setting. The development of effective vaccines to generate robust and durable responses as single agents and/or combined with anti-PD(L)1 remains an unmet need in aUC. Clinical trial information: NCT03628716.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.511
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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