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I recognize today that I had an amazing day,

tomorrow I return to being my gardner

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Brian Van Tine ASCO ªº¤fÀY²³ø

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PFS for the ASS1 negative was 8.9 months 8.9 months 8.9 months !!

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A phase II study of ADI-PEG 20 in combination with gemcitabine and docetaxel for the treatment of soft tissue sarcoma.

Citation:

J Clin Oncol 37, 2019 (suppl; abstr TPS11079)

Author(s): Brian Andrew Van Tine,®¤²¤.

Abstract:

Background: The combination of gemcitabine (G) and docetaxel (D) is a standard second line therapy for soft tissue sarcoma (STS) with a modest response rate. Recent studies have looked to add agents to enhance response. We have shown that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n = 708) (Bean et al., 2016, Cell Death and Disease), and that this loss is associated with a reliance on extracellular sources of the amino acid arginine. The arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG 20) depletes extracellular arginine. Preclinical studies have demonstrated that arginine starvation and D administration induce c-Myc-driven hENT1 surface expression overcoming intrinsic cell surface G transporter related resistance. To test this hypothesis, we opened this multi-institutional randomized phase II trial examining the safety and efficacy of ADI-PEG 20 with G + D in STS (NCT03449901) in July of 2018. Methods: Eligible patients are adults with metastatic or unresectable histologically or cytologically confirmed FNCLCC grade 2 or 3 STS that would be standardly treated with G and/or D. Patients are treated with ADI-PEG 20 at a dose of 36 mg/m2 via intramuscular injection on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. G will be given intravenously at a dose of 750 mg/m2 over 90 minutes on Days 1 and 8 and D will be given intravenously at a dose of 75 mg/m2 over 60 minutes on Day 8 of each cycle. The median PFS of metastatic sarcoma patients receiving the standard G + D treatment was estimated to be 6.2 months in a randomized phase II study (Maki et. al., 2007, JCO). With the addition of ADI-PEG 20, we target to improve the median PFS to 9 months, a 45.2% (2.8 months or 12 weeks) improvement in patients treated on G + D + ADI-PEG 20 against the null hypothesis median PFS of 6.2 months to achieve 80% power to detect the improvement in PFS at a 5% alpha level. Tumor specimens (pre- and post-ADI-PEG 20 during week -1) and blood are collected for correlative studies including metabolomics, pharmacodynamics, immunogenicity and ASS1 biomarkers. Quality of life will be measured using FACT-G7. Clinical trial information: NCT03449901

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¥_·¥¬P520§Y±N¤½§GSarcoma¤G´Áµ²ªG¡A¦p¦ó¸ÑŪ¡C

­Ó¤H»{¬°¥i°Ñ¦Ò«e¦~FDA®Ö­ã¥[³t¼f§åªºSarcoma·sÃÄEZH2¨Ó§@°Ñ¦Ò¡G

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EZH2ªºµ²ªG¡G

ORR 15%

Mpfs 23.7 weeks (5.5 months)

overall disease control rate 26%

¥H¤U¬°¤åÄm»P³ø¾É³sµ²¡G

www.ncbi.nlm.nih.gov/pmc/articles/PMC7140314/

www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tazemetostat-advanced-epithelioid-sarcoma

----------------------------------------------------------------------------------

PS.

Polaris Group

January 18, 2019

Combination Studies

1. Phase II Soft Tissue Sarcoma (ongoing)

¡´ADI-PEG 20 + Gemcitabine + Docetexal

¡´Sponsor: Washington University

¡´Lead Principal Investigator: Brian Van Tine

¡´Single arm study, 78 patients, multiple centers

¡´17 patients enrolled

¡´2 complete response and 2 partial response as of Dec 31, 2018

¦^ÅUDec 31, 2018

¡´¡u17 patients enrolled¡v

¡´¡u2 complete response¡v and ¡u2 partial response ¡v

¦Ó¤µ110/04/04¤½§i

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2021/04/16

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma

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¯f¤H¼Æ=789 vs. 792(¦³¥ýÀË´ú¹LPD-L1 CPS ≥5ªº¯f¤H¡÷´N¬O¹ïOpdivo³o­Ó§K¬ÌÀøªk¤ñ¸û¦³®Äªº)

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Opdivo 240 mg + mFOLFOX6 vs. mFOLFOX6¨C2¶g

Opdivo 360 mg + CapeOX (capecitabine and oxaliplatin) vs. CapeOX¨C3¶g

mPFS= 7.7 months (95% CI: 7.0, 9.2) vs. 6.0 months (95% CI: 5.6, 6.9) (HR 0.68; 95% CI: 0.58, 0.79; p<0.0001)

¡´¹êÅç²Õ¥­§¡µL¯e¯f´_µo¦s¬¡´Á¡A¤ñ¹ï·Ó²Õ¦h1.7­Ó¤ë¡F¹êÅç²Õ¯e¯f´_µoªº­·ÀI¬O¹ï·Ó²Õªº0.68­¿¡A¤]¥i¥H»¡¹êÅç²Õ¯e¯f´_µoªº¾÷²v¡A¤ñ¹ï·Ó²Õ¤Ö¤F32%¡I

mOS=14.4 months(95% CI: 13.1, 16.2) vs. 11.1 months (95% CI: 10.0, 12.1) (HR 0.71; 95% CI: 0.61, 0.83; p<0.0001)

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This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA¡¦s assessment. The FDA approved this application approximately 5 weeks ahead of the FDA goal date.

This application was granted priority review and orphan drug designation..

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¬°¤F¥[§Ö§å­ã¸~½FÃĪ«¡AFDAªº¸~½F¾Ç¨ô¶V¤¤¤ßOncology Center of Excellence (OCE) ©ó2018¦~6¤ë±Ò°Ê¤F¡§¸~½F¾Ç¨ô¶V¤¤¤ß¹ê®É¸~½F¾Ç¼f¬d¡]OCE-RTOR¡^¸ÕÂI­p¹º¡÷´N¬O¥H¬Û¹ï²³æ¡B²×ÂIª½±µªº¬ã¨s³]­p(¦pORR, mPFS)¡A§Ö³t§å­ã¸~½FÃĪ«¡I

±qRTOR®É¶¡ªí¤¤¥i¥H²M·¡¦a¬Ý¨ì¡ANDA / BLAªº§å­ã¥i¥H¦b2¨ì24¶g¤º§¹¦¨¡]¬Û¤ñ¤§¤U¡A§Y¨Ï¬OÀu¥ý¼f®Öpriority review³£Áٻݭn6­Ó¤ë¡^

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1. Kisqali®¡]ribociclib¡^¬OFDA¦bRTOR­p¹ºªº¤£¨ì¤@­Ó¤ë¤º§å­ãªº­º­Ó§ÜÀùÃĪ«¡A¥Î©óªvÀøÀù¯g±ß´Á©ÎÂಾ©Êªº°±¸g«á°ü¤kªºHR¶§©Ê¡AHER2³±©Ê¨Å¸¢Àù¡C(¹ê»Ú§å­ã®É¶¡¬°3¶g¡I)

2. Adcetris®¡]brentuximab vedotin¡^¦bµuµu2¶g¤º´NÀò±o¤FFDAªº§å­ã±q¥Ó½Ð¤§¤é°_¡A¦]¬°¼f®Ö¤p²Õ¼ô±x¬ã¨s²Ó¸`¡A¨Ã¥B¤w¸gÀò±o¤FÃöÁä¼Æ¾Ú¡C

3. Kyprolis®¡]carfilzomib¡^»PÃþ©T¾J¡AÁp¦X¥Î©óªvÀø´_µo©Ê©ÎÃøªv©Ê¦hµo©Ê°©Åè½F¬O¥t¤@¶µ¦¨¥\ªº§å­ã¡A¤]¬O¦b¤@­Ó¤ë¤º¡I

§Ú­Ì¦A¦^¹LÀY¨Ó¬Ý¥_·¥¬Pªº³n²Õ´¦×½FSoft tissue sarcoma(ADI+Gem+Doc)

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1. ¦A¦¸±j½ÕAACRªº«GÂI¡÷¥[¤FADI¤§«á¡AA+D¥i¥H»¤¾Éc-Myc-driven hENT1 surface expression ¶i¦ÓÅýGEMªº§ÜÃĩʤU­°¥B§l¦¬Åܦh(§í¨î¸~½F²Ó­M¥Íªøªº¯à¤O¤]¤j¤j¦a´£¤É¤F)

2. ¦³¥v¥H¨Ó¡A¹ï·Ó²ÕGem+DocªºmPFS³Ì¦nªº¬O6.2months (Maki et. al., 2007, JCO, RCT phase 2 study)

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Opdivo 240 mg + mFOLFOX6/Opdivo 360 mg + CapeOX

mPFS= 7.7 months (95% CI: 7.0, 9.2) vs. 6.0 months (95% CI: 5.6, 6.9) (HR 0.68; 95% CI: 0.58, 0.79; p<0.0001)

¡´¹êÅç²Õ¥­§¡µL¯e¯f´_µo¦s¬¡´Á¡A¤ñ¹ï·Ó²Õ¦h1.7­Ó¤ë¡F¹êÅç²Õ¯e¯f´_µoªº­·ÀI¬O¹ï·Ó²Õªº0.68­¿¡A¤]¥i¥H»¡¹êÅç²Õ¯e¯f´_µoªº¾÷²v¡A¤ñ¹ï·Ó²Õ¤Ö¤F32%¡I

¡´²{¦b·dÀ´²Î­p¾Ç¤F¶Ü¡H¬°¤°»òOpdivo¥uĹ1.7­Ó¤ë¡Ap<0.0001¡H¦]¬°¹êÅç²Õªº¼Ë¥»¼Æ¬O789¤H¡IADI+Gem+Doc¬O75­Ó¤H¡A©Ò¥H¥²»PĹ2.8 months¤~¹F¼Ð¡I

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mPFS=9months¡÷Real-Time Oncology Review (RTOR)¡÷2¶g¨ì24¶gª½¨úÃÄÃÒ¡I

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