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¡´Tecentriq³æÃÄNSCLC phase 3 OAK study-----2016/10/19FDA approved

Tecentriq pk Docetaxel

ORR= 58/425 (14%) pk 57/425 (13%)

CR= 6/425 (1%) pk 1/425 (<1%)

PR= 52/425 (12%) pk 56/425 (13%)

SD= 150/425 (35%) pk 177/425 (42%)

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ORR=43/241 (18%) pk 36/222 (16%)

CR=5/241 (2%) pk 1/222 (<1%)

PR=38/241 (16%) pk 35/222 (16%)

SD=79/241 (33%) pk 85/222 (38%)

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Tecentriq (¤]¥sMPDL3280A)¦bASCOªºµoªí

Safety and efficacy of MPDL3280A (anti-PDL1) in combination with platinum-based doublet

chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Tecentriq + carboplatin + paclitaxel= (Arm C, n=8)

Tecentriq + carboplatin + pemetrexed= (Arm D, n=14)

Tecentriq + carboplatin + nab-paclitaxel= (Arm E, n=15)

G3-4 ¯Åªº°Æ§@¥Î

anemia (Arms D & E, 7%),

neutropenia (Arm C, 13%; Arm D, 7%)

thrombocytopenia (Arms D & E, 7%)

No pneumonitis was seen.

¡´Keytruda+car+pem¤@½u¥ÎÃĪvÀønon-squamous NSCLCªºkeynote-021----FDA ¥Hphase 2ªº¼Æ¾Ú©ó

2017/05/10 approved; ¦ý¬Ophase 3ªºkeynote 189¦b2017/10/27ºM¾P¼Ú·ùÃÄÃÒ¥Ó½Ð,¦]¬°Áٻݭn

¥]¬AOS¬°co-primary endpointªº¼Ï¯Ã¹êÅç!!!

Keytruda+car+pem pk car+pem

ORR= 33/60 (55%; 95%CI 42¡V68) pk 18/63 (29%; 95%CI 18¡V41)------p=0.0016

mPFS= 13¡P0 months (95% CI 8¡P3~not reached) pk 8¡P9 months (95% CI 4¡P4¡V10¡P3)--p=0.010

6-months OS= 92% pk 92%-----------¨â²Õ¨S¦³®t²§!!!----©Ò¥H¼Ú·ùÁÙ¬O¤ñ¸û«O¦u,´N¬O­n¬ÝmOS!!

>=G3ªº°Æ§@¥Î¨â²Õ¨S¦³®t²§!!!

anaemia= (seven [12%] of 59) pk (nine [15%] of 62

decreased neutrophil count= (three [5%]) pk two [3%]

¡´IDO+Keytruda Phase 1/2 (2017 ASCOªº¼Æ¾Ú)-----ADIªº«l¼Ä!!!·|¤£·|³QADI¥´Ãz?´Á«Ý¤¤....

NSCLC, phase 1/2

ORR¡÷35%(14/40)

CR¡÷5%(2/40)

PR¡÷30%(12/40)

DCR¡÷63%(25/40)

­ì¹êÅçECHO-202, Keynote-037, NCT 02178722 for all solid tumor

n=463¡÷primary completion: 2018/11 (ÁÙ¦³¤@¦~§¹¦¨)

Polarisªºdata­n¦h¦n?¨ä¹ê¬OÁp¤°»òÃĦѴ­³£¤£½T©w!!!TecentriqÁÙ¨S¶}©l, KeytrudaÀ³¸Ó¤]¨S¨º»ò§Ö¡I

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All of the ITT patients were evaluated for toxicities as listed in Table 3. Overall, the toxicity was minimal and tolerated. The most common treatment-related adverse events were grade 1/2 skin rash (9.3%), grade 1/2 hyperuricemia (7%), and grade 3/4 leukopenia (7%). There were 2 patients who had grade 3/4 neutropenic fever (4.7%), and 2 patients had grade 3/4 anemia (4.7%). One patient had grade 4 tumor lysis syndrome and an infection and died; the death was attributed to both grade 4 events, consistent with AML and possibly ADI-PEG20. Due to the development of tumor lysis syndrome in this patient, prophylactic use of allopurinol was subsequently prescribed for all of the enrolled patients. Another patient had grade 4 anaphylactic shock and recovered without sequelae.

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-Keytruda+car+paclitaxel or nab-paclitaxel phase 3ªºKeynote 407

¡´MerckºM¾Pkeynote 189ªº¼Ú·ùÃÄÃÒ¥Ó½Ð!!!------À³¸Ó¬O¦]¬°Phase 3ªºOS¤£ÅãµÛ!!!

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Safety and efficacy of MPDL3280A (anti-PDL1) in combination with platinum-based doublet

chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Tecentriq + carboplatin + paclitaxel= (Arm C, n=8)

Tecentriq + carboplatin + pemetrexed= (Arm D, n=14)

Tecentriq + carboplatin + nab-paclitaxel= (Arm E, n=15)

G3-4 ¯Åªº°Æ§@¥Î

anemia (Arms D & E, 7%),

neutropenia (Arm C, 13%; Arm D, 7%)

thrombocytopenia (Arms D & E, 7%)

No pneumonitis was seen.

¡´¦ý¬ORoche³ºµM¤]§âTecentriqÁp¤ÆÀøÃĪºNCT01633970(Phase 3)¤¤¤î¤F!!!---FDA clinical trial

ºô¯¸¤w¬d¤£¨ì³o­ÓÁ{§É¹êÅç!!¦b³o­Ó®É­ÔRoche³ºµM§âTecentriq¥[¤J¤FADI+Pem+Cisªº¦æ¦C!!!

µª®×¤£¬O¤w¸g«Ü©úÅã¤F¶Ü¡H

¡´Merck, BMS & Roche³£¹J¨ì¤F¤@­Ó¹L¤£¥hªº²~ÀV¡A³o®ÉÁpADIÅS¥X¤F¤@¹DÀÆ¥ú¡I

Go go polaris!!!

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¥m¾´ ½Ð°Ý§Aª¾¹D¤°»ò¬O ¾´¾´¾´¾´¾´¾´?
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»«¹£¤j¥­¦w¡A¨ØªA§AªºÁxÃÑ&¨£ÃÑ¡AÅý½Ñ¦h¬P¤Í´ç¹L¨º¬q¬ÛÀá¥Hªj`¤â«ü»Q¨ì¨£°©ªº¤é¤l.

¾´¾´¡A§AÄ~Äò¥[ªo¡A¬¡¦b¦Û¤vªº¥@¬É§a¡I

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¤é¥»ªºE7080®ÄªG¥»¨Ó´N¤£¿ù ¨xÀù¤]«Ü¦n ¥¦¬OVEGFR ¤w¸g¦³ÃÄÃÒªº

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¥H¤U¼Æ¾Ú¬Ý¨Ó,keytrudaÁp¦XE7080ªºÁ{§É¼Æ¾Ú«Ü¤£¿ù

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Á{§Éµ²ªG¡G¦b©Ò¦³30¦ì±wªÌ¤¤¡A19¦ì¸~½F©úÅãÁY¤p¡A¦³®Ä²v63%¡F9¦ì±wªÌ¸~½Fí©w¤£ªø¤j¡A¯e¯f±±¨î²v96%¡C¦b12¦ì¥¼¸g¹L¨t²ÎªvÀøªº12¦ì±wªÌ¤¤¡A10¦ì±wªÌ¸~½F©úÅãÁY¤p¡A¦³®Ä²v83%¡F2¦ì±wªÌ¸~½Fí©w¤£ªø¤j¡A¯e¯f±±¨î²v100%¡C

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3.2016¦~ªºESMO¦~·|¤½¥¬¤FPD-1§ÜÅéKeytrudaÁp¦X7080¥Î©ó¦hºØ¸~½Fªº¤p³W¼ÒÁ{§É¼Æ¾Ú¡A±±¨î²v°ª¹F100%¡C

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Á{§Éµ²ªG¡G13¦W±wªÌ¤¤7¦ì¸~½FÁY¤p¡A¦³®Ä²v54%¡F6¦ì±wªÌ¸~½F¨S¦³ªø¤j¡A¯e¯f±±¨î²v100%¡C

¬èëADI-PEG20»PTecentriqªºÁp¦X¥ÎÃĦ³§ó«G²´ªºÁ{§Éµ²ªG

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·|­û¡G¥m¾´10141821  µoªí®É¶¡:2017/10/29 ¤U¤È 03:42:42²Ä 1619 ½g¦^À³
»aÃÇ

§A¶Kªº¤å³¹¸Ì¡A¦³½g¥i¥H¯}¦Ñªº²Ä¤G½b¡A¥u¤£¹L§A¤£ª¾¹D¡C

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·|­û¡G»aÃÇ10141976  µoªí®É¶¡:2017/10/29 ¤U¤È 03:21:39²Ä 1618 ½g¦^À³
¥m¾´:

§A³stimeline³£·d¿ù¤F¡A´N¤£­n¦A¦ºÄñÄꥴ¡A·d±o®æ½Õ³£§Ö¨S¤F¡C

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Å¥»¡§A¦Û»{¬°«Ü¥Î¥\¡A¨º´N´£¨Ñ§A¤@½g¤å³¹¦n¦n¬ã¨s¡A¸Ì­±·d¤£¦nÂ泯EX¥h¦~2´Á¤£²z·QªºÃöÁä­ì¦]¡C

Differential effects of cyclophosphamide and mycophenolate mofetil on cellular and serological parameters in patients with systemic lupus erythematosus

www.ncbi.nlm.nih.gov/pmc/articles/PMC4422597/

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·|­û¡G¦Ñ´­10141055  µoªí®É¶¡:2017/10/29 ¤W¤È 07:49:21²Ä 1613 ½g¦^À³
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Argininosuccinate synthase 1 is an intrinsic Akt repressor transactivated by p53

Sci. Adv. 2017;3: e1603204

¥Ñ¤é¥»ªF¤jªº¾ÇªÌ­Ì°µªº¬ã¨s,§¹¥þ¨S¦³¥_·¥¬Pªº¸êª÷ÃÙ§U¦b¤º-----©Ò¥H¬O«D±`«ÈÆ[ªº¬ã¨s!!!

´Á¥Z¬OScience advances¡÷¥Ñ¬ü°ê¬ì¾Ç«P¶i·|(AAAS)¦b2015/02¥Xª©ªºopen access,¥Ø«eÁöµMÁÙ¨S¦³

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p53·|±Ò°Ê¤@¨t¦Cªº

target gene (ASS1, EPPK1, EPS8L2, APOBEC3C, FDXR, MDM2, and RRM2B)¨Ó«OÅ@²Ó­Mªº°·±d.

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¤U´å,§@ªÌ­Ì¥Î¤F«Ü¦h¹êÅç«Çªº¤èªk(¥Î¤HÃþ¤j¸zª½¸zÀùªº²Ó­M®è,±µ¨üdoxorubicin¤ÆÀøÃĪ«,¥ÎPCR,

Western blot)¨ÓÃÒ¹ê!!!----¡´ASS1·|ª½±µ³Qp53¬¡¤Æ!!!ASS1¬Op53ªºª½±µ¤U´å!!!

ASS1 was confirmed to be a direct downstream target of p53!!!

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A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With

Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic

Solid Tumors

This global, multicenter, open-label study will evaluate the safety and tolerability

of atezolizumab in combination with other immune-modulating therapies in the treatment

of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm

(Arm A) will focus primarily on participants with advanced or metastatic non-small

cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus

pegylated interferon alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus

PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with

advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma.

The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent

and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Atezolizumab

will be administered as intravenous (IV) infusion every 3 weeks (q3w).

Official Title: A Phase Ib Study of The Safety And Pharmacology of Atezolizumab

(Anti−Pd-L1 Antibody) Administered With Ipilimumab, Interferon-Alpha, or Other

Immune-Modulating Therapies in Patients With Locally Advanced or Metastatic Solid

Tumors

Estimated Enrollment: 200

Actual Study Start Date: August 18, 2014

Estimated Study Completion Date: February 28, 2019

Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)

¾´¾´¾´ª¾¹DPegasys (interferon alfa-2a)ªº°Æ§@¥Î¦³¦h¤j¶Ü???¤µ¤ÑRoche¬Ý¨ìªº¬OADI°£¤F­°¸ÑArg.

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high expression (>=50%) T-effector-INF-gamma (HR 0¡P43; 95% CI 0¡P24¡V0¡P77)

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2.ADI+Pem+Cis+Tecentriq¡ARoche¬°¤°»ò­n³o»ò«æ?½Ð¬ÝKeytruda¦b·F¤°»ò

Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous

non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study

RocheªºTecentriq¤]¤£¬O¬Ùªoªº¿O,Áp3ÃĤ]¤w¶i¤JPhase 3!!!

A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed

Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are

Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

(IMpower 132) NCT02657434

Estimated Enrollment: 568

Actual Study Start Date: April 30, 2016

Estimated Study Completion Date: November 30, 2019

Estimated Primary Completion Date: November 30, 2019 (Final data collection date for primary outcome measure)

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or

Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous

or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Estimated Enrollment: 555

Actual Study Start Date: July 20, 2015

Estimated Study Completion Date: April 23, 2020

Estimated Primary Completion Date: January 17, 2019 (Final data collection date for primary outcome measure)

3.§A­Ì·|«Ü¾á¤ßADI+Pem+Cis+Tecentriq°Æ§@¥Î¶Ü¡H---¥i¥H°Ñ¦ÒTecentriq (¤]¥sMPDL3280A)¦bASCOªºµoªí

Safety and efficacy of MPDL3280A (anti-PDL1) in combination with platinum-based doublet

chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Tecentriq + carboplatin + paclitaxel= (Arm C, n=8)

Tecentriq + carboplatin + pemetrexed= (Arm D, n=14)

Tecentriq + carboplatin + nab-paclitaxel= (Arm E, n=15)

G3-4 ¯Åªº¨ì§@¥Î

anemia (Arms D & E, 7%),

neutropenia (Arm C, 13%; Arm D, 7%)

thrombocytopenia (Arms D & E, 7%)

No pneumonitis was seen.

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Ps. ¦Ñª¯¤j¥[ªo¡A¦Ñ¤Ñ·Ý·|²²ÅU§µ¶¶¬°®a¤H¥I¥Xªº«Ä¤l¡C

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ÁÙ¬O¬èë¥Í§ÞªÑ¦­¤é²æ­L´«ªÑ¡AÂà°©Åܤj¤H°Ú!!

Thanks a million¡G)

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A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors

(Offical Title: A Phase Ib Study of The Safety And Pharmacology of Atezolizumab (Anti−Pd-L1 Antibody) Administered With Ipilimumab, Interferon-Alpha, or Other Immune-Modulating Therapies in Patients With Locally Advanced or Metastatic Solid Tumors)

clinicaltrials.gov/ct2/show/NCT02174172

(§Æ±æ¦Ñ´­¤j¦pªG¦³®É¶¡¬°¤j®a¸Ñ»¡¤@¤U³o­Ó¸ÕÅç)

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