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  • American Society of Clinical Oncology (ASCO)  (2)
  • Hata, Akito  (2)
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  • American Society of Clinical Oncology (ASCO)  (2)
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  • 1
    Online Resource
    Online Resource
    Radiation therapy (RT)-free pembrolizumab plus chemotherapy (P+C) for PD-L1 TPS ≥50% locally advanced non-small cell lung cancer (LA-NSCLC): An early report analyzing depth of response from multicenter single arm phase II study (Evolution trial: WJOG11819L).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 8544-8544
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 8544-8544
    Abstract: 8544 Background: Standard of care for unresectable LA-NSCLC is chemoradiation therapy (CRT) followed by durvalumab (D). Survival curves of P monotherapy/P+C for PD-L1 TPS ≥50% stage IV NSCLC suggested possible comparable survival to CRT for stage III patients (pts). Moreover, some studies of neoadjuvant C+immunotherapy (I) for stage III pts have demonstrated high pCR and MPR rates, implying potentially outstanding efficacy of C+I for earlier stage. We thus hypothesized P+C without RT in PD-L1 ≥50% LA-NSCLC pts provides a comparable efficacy to CRT followed by D while avoiding CRT-induced severe toxicities. Methods: This early report focuses on depth of response in a phase II study by WJOG. P with platinum plus pemetrexed (PEM) (non-squamous) or P with carboplatin plus nab-paclitaxel (squamous) was administered every 3 weeks without RT. After four cycles of induction P+C, P with PEM (non-squamous) or P alone (squamous) was continued until progression or 2 years. The primary endpoint was PFS rate at 2 years. Results: Between May 2020 and February 2022, 21 pts were enrolled. Median age was 74 (range, 53-89). Stage IIIA/B/C included 12 (57%)/6 (29%)/3 (14%), respectively. Histologic subtypes were 13 (62%) adeno, 5 (24%) squamous, and 3 (14%) others. Investigator-assessed best response: 8 (38%) CR; 10 (48%) PR; 2 (10%) SD; and 1 (5%) NE were confirmed, resulting in response rate (RR) of 86% and disease control rate of 95%. RR of TPS 50-79% and 80-100% were 78% and 92%, respectively. Deep response (DR): defined as tumor shrinkage ≥80% was obtained in 12 (57%) of 21 pts. DR was accomplished in 4 (44%) of 9 TPS 50-79% and 8 (67%) of 12 TPS 80-100%. Median time to response was 43 (range, 41-92) days. Early tumor shrinkage (ETS): PR-in at the time of first CT evaluation (6 weeks) was achieved in 16 (89%) of 18 CR+PR pts. At the time of data cut-off, median follow-up period was 18.5 (range, 0.3-29.0) months, and 14 (67%) of 21 pts were progression-free. All 12 pts achieving DR, including all 8 CR were progression-free, also in 14 (88%) of 16 ETS pts. Three pts after local progression received salvage definitive-CRT. Median number of P administrations was 20 (range, 1-35). AEs ≥grade 3 were observed in 11 (52%) pts, including: 2 (10%) pneumonitis; 2 (10%) pneumonia; 1 (5%) diarrhea; 1 (5%) ALT elevation; and 1 (5%) acute heart failure, excluding hematological AEs. There was one (5%) possible grade 5 AE (pneumonia). Conclusions: RT-free P+C exerted a notably high RR, including some CRs. The deeper/earlier response and higher PD-L1 TPS could be associated with the higher progression-free incidence at the data cut-off. To investigate our hypothesis: RT-free P+C can be a less toxic curative option in selected LA-NSCLC pts with PD-L1 TPS ≥50%, further matured data is warranted. Clinical trial information: NCT04153734 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.8544
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Afatinib (AFA) plus bevacizumab (BEV) combination after osimertinib (OSI) resistance in advanced EGFR-mutant NSCLC: A phase II study (ABCD-study).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 9117-9117
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 9117-9117
    Abstract: 9117 Background: After OSI failure, various resistant mechanisms such as C797S and uncommon EGFR mutations, or MET amplification have been reported. AFA is an irreversible EGFR-TKI with a potency as pan-HER inhibitor, including high sensitivity to uncommon EGFR mutations. Many clinical studies have also shown a synergy of EGFR-TKIs and VEGF inhibitors. Methods: ECOG PS 0-1 patients (pt) with EGFR-mutant NSCLC were enrolled after OSI resistance. AFA was prescribed at 30-40 mg QD, and BEV was administered at 15 mg/kg tri-weekly until progression. Plasma/histologic rebiopsied samples taken after OSI failure but before enrollment were analyzed to examine resistant mechanisms including gene alterations/copy-number gain using cancer personalized profiling by deep sequencing. Results: Between January 2018 and October 2020, 28 pts were enrolled. Mutation subtypes were: 9 (32%) Del-19; 5 (18%) Del-19+T790M; 5 (18%) L858R; 7 (25%) L858R+T790M; 1 (4%) Del-19+L858R+T790M; and 1 (4%) G719S. Median line of prior OSI was 2 (range, 1-9). CR/PR was obtained by prior OSI in 24 (86%) pts. Regarding AFA+BEV efficacy, one (4%) CR, 4 (14%) PR, and 17 (61%) SD were confirmed, resulting in response rate of 17.9% and disease control rate of 78.6%. Median DoR was 9.0 (range, 4.2-22.3) months. Median PFS and OS were 2.7 (95% CI, 2.0-4.6) months and not reached, respectively. Twenty-eight (100%) plasma and/or 21 (75%) histologic rebiopsies identified: 17 (61%) TP53; 15 (54%) T790M; 9 (32%) uncommon EGFR; 9 (32%) MET; 6 (21%) C797S; 3 (11%) BRAF; 2 (7%) HER2; 2 (7%) KRAS; and 2 (7%) PI3K mutations; or 14 (50%) EGFR; 6 (21%) MET; and 2 (7%) HER2 amplifications. One (4%) small cell transformation was found. Among 6 C797S pts, 1 CR, 4 SD, and 1 PD were confirmed. Three (33%) of 9 uncommon EGFR and 1 (50%) of 2 HER2 mutation positive pts achieved radiographic response. All 15 T790M-positive pts showed no response, but 5 (38%) of 13 T790M-negative pts responded to AFA+BEV. None (0%) of six pts with EGFR downstream signaling mutations such as BRAF, KRAS, or PI3K responded. Five (50%) of 10 pts without T790M/BRAF/KRAS/PIK3 mutations exhibited confirmed response. FAT1 mutation was found in two (40%) of 5 responded pts. Dose reduction/interruption of AFA was performed in 15 (54%) pts. Median number of BEV administrations was 4 (range, 1-32). There were neither TRD nor ILD. Adverse events ≥grade 3: hypertension (29%); proteinuria (7%); diarrhea (7%); and rash (4%) were observed. One (4%) grade 4 duodenal perforation was reported. Conclusions: AFA+BEV after OSI resistance demonstrated moderate efficacy and favorable safety. A small portion of C797S pts exhibited the sensitivity. Higher potency was suggested in T790M/BRAF/KRAS/PIK3 mutation-negative and uncommon EGFR/HER2 mutation-positive pts. Selected population could obtain clinical benefit from AFA+BEV, based on rebiopsy results after OSI resistance. Clinical trial information: UMIN000030545.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.9117
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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