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-US UCLA GI Trials

Gastric Cancer Pancreatic Cancer Colorectal Salvage Colon A B st A V 1 Line BMS Lag 3 Inhibitor st Halozyme Medimmune I TO 1 Line B VE FOLFOX/placebo vs. PR nab-paclitaxel + gemcitabine FOLFOX + + Advaxis 1st Line I TO FOLFOX/relatlinib T +/- PEG-PH20 P Durvalumab + Monalizumab Personalized Vaccine Trial WL

Astellas (Claudin Ab) JGDP A V Abbvie M14-006 1st Line TO B VE TO Amgen CapeOx +/- Claudin 18.1 Gem/nab-paclitaxel +/- FOLFIRI/Bev vs FOLFIRI/ABT- I TO T-VEC 299+atezo mAb Olaturumab (Ab PDGFR) P 165 Liver met injections st (DLL4 and VEGF Inhibitor) 1 Line 2nd Line FIGHT Trial (FGFR+) CanStem 111P A V B VE MK-1454 (Sting) FOLFOX +/- FPA 144 nab-paclitaxel + gemcitabine CanStem 303C I TO TO +Pembro cutaneous/liver FOLFIRI + Bevacizumab +/- +/- BBI608 P met injection 1st Line HER2+ BBI-608 FOLFOX/ +/- PICI Trial Aduro/Novartis (Sting) Pembro nd Array 162 nab-paclitaxel + gemcitabine 3 Line +PD-1 cutaneous/liver met & Beyond MEDK 162/Nivo/Ipi 2nd Line + + CD40 injection Amgen 20140318 & Beyond T-VEC + Pembro ARMO AM0010-301 TO Forty Seven liver met injections Biliary 2nd Line FOLFOX +/- peg-IL-10 CD47 Antibody + (KRAS WT or Mutant) BMS Cabira Gem/cis/PEGPH20 vs Cabira/Nivo +-2nd line chemo Amgen 20140318 Gem/cis/PEGPH20/Atezolizu T-VEC + Pembro mab liver met injections HA high

Abbvie, Stemcentryx SC-006 + PD-1 (Anti-stem cell ADC) Satellite Site Key A – Alhambra T – Torrance TO—TRIO I – Irvine P – Pasadena B- Burbank V – Valencia PR – Porter Ranch WL – Westlake Village

September 2018 For any further information, please contact Dr. Hecht or Dr. Wainberg. Currently Accruing Phase 1 Trials Trial Indications

ARRAY 382: CSF1R inh with Pembro Pancreatic, Ovarian, and post-IO solid tumors

Corvus CPI-444 (AdenoR antagonist) +/- RCC

CytomX: anti-CD166 mAb Solid tumors

Deciphera DCC-2618 (KIT/PDGFR inhibitor) GIST

FivePrime: FPA-150, a B7-H4 checkpoint inhibitor Solid Tumors

Forty Seven 5F9004: Hu5f9-G4 (anti-CD47)with cetuximab MCRC

LOXO-Trk-15002: entrectinib (Trk inhibitor) NTRK fusion positive solid tumors

LOXO-Ret-292: RET inhibitor RET-fusion positive solid tumors

MedImmune MEDI0562(OX40 agonist) w/ Durva or Treme Solid tumors

Novartis NIR178 (adenosine A2a receptor) + PDR001 (PD-1 antibody) Urothelial, DLBCL, RCC, NSCLC (IO naïve, ≤3 prior tx’s)

Pfizer C0541001: PF4103 (HER2 ADC) HER2+ breast, gastric, GE junction

Pfizer C3661001: PF3600 (CDK2/4/6 inhibitor) ER+ breast, TNBC, Ovarian

Pharmacyclics PCYC-1128-CA: ibrutinib combinations GI, GU

PICI0002: APX005M (CD40 agonist)w/Gem/Abrax +/- Nivo Pancreas 1L

PsiOxus ColoAd-1003: oncolytic adenovirus CRC, Bladder, HSNCC, Salivary, NSCLC

Tracon 253: Pan Androgen Receptor inhibitor Prostate (CRPC)

TRIO 028 and 13: talazoparib Moderate/severe liver dysfunction (all solid tumors, bili ≥ 1.5) Trial Opening Soon Indications AbbVie M14-006: ABT165, a Dual Variable Domain Ig Solid tumors

Medivir BPT-201: inhibits IAP’s Solid tumors Pfizer C3881001: TGF Beta receptor inhibitor Breast, prostate, HNSCC, , mesothelioma, pancreatic, colorectal, renal cell, hepatocelullar Rgenix RGX-202-001 Small Molecule Inhibitor of the GI Creatine Transporter, SLC6a8 Outside Phase I Indication/Mechanism of Action Aduro pLADD Listeria-based neoantigen targeted Listeria vaccine

Advaxis ADXS-NEO-02 Listeria-based neoantigen targeted Listeria vaccine

KITE-718-301 (Hermosa-1) MAGE CAR-T cell Therapy for Bladder/NSCLC/GI/Gyn

Selected WAM Team Trials Indication Astellas 8374-CL-0101 An Immune Checkpoint Inhibitor, as a Single Agent and in Combination with in Subjects with Advanced Solid Tumors F Star FS118-17101 FS118, a LAG-3/PD-L1 Bispecific Antibody, in Patients After Prior PD-1/PD-L1 Containing Therapy Nektar 16-214-02 NKTR-214 and Nivolumab in Patients with Select Solid Tumors

NYESO SCT ACT of NYESO TCR transduced stem cells + PBMCs for NYESO+ solid tumors in HLA A02.01+ patients Tesaro 4020-001: TIM-3 agonist with PD1 inhibitor NSCLC and melanoma HER2+ Breast Cancer Updated 8/2018

Presurgical METASTATIC HER2+ window of opportunity “HER2CLIMB” ONT380-206 “DESTINY” DS8201-A-U201 “SOPHIA” Cape/trastuzumab +/- tucatinib Phase III open label DS-8201 Encourages active CNS mets vs trastuzumab + chemo physician’s Ph II single arm study, requires prior No prior capecit (1 yr washout lapat) choice. Must have had 2-HER2- tx with T-DM1, no limit on prior Open TRIO-US & directed tx and no more than 3 in TRIO-030 ODM number of therapies metastatic setting UCLA (LH, Encino, Torrance, PR, All tumor types Open UCLA (LH, Pasdena) UCLA only (LH, PR, Alhambra, Window of Opportunity (Hurvitz) Alhambra, Pasdena, Valencia, Pasdena, Valencia, Tumor >1.0 cm, 14-21 Irvine, Burbank, WV Burbank,Ventura) days AR inhibitor (Hurvitz) (Hurvitz) presurgically ARX788-1711 HER2 ADC with 2 microtubule Open TRIO-US & Pieris 343 Phase I UCLA (LH, Pasadena, disrupting payloads Trastuzumab altered to stimulate Phase I dose escalation; immune response Valencia, Burbank, WV) DS 8201-A-U105 (Slamon) No limit on prior number of Phase I dose escalation; therapies, must have failed standard No limit on prior tx, must have DS8201 + Nivolumab tx; no h/o pneumonitis/lung dz; BMI failed std tx HER2 1+ to 3+ MBC or urothel ca 18-32 Open UCLA (SM/WW only) Dose escalation of DS8201. (Hurvitz) Open UCLA (SM/WW only) Call No limit on prior number of for open slot therapies, must have failed (Hurvitz) standard treatment; no h/o pneumonitis/ ILD Open UCLA (LH, Pasdena) For trial eligibility & enrollment info contact: (Hurvitz) [email protected] For phase I HER2 studies email [email protected] Updated 8/2018 HER2 Normal Breast Cancer

NeoADJUVANT ADJUVANT METASTATIC

NATALEE TRIO-B11 Phase II portion Phase III open label ribociclib ER+ post-meno x 3 years; 1:1 randomization Hormone Receptor Positive Triple Negative 4 mos copanlisib/AI Randomization w/in 1 year vs copan/palbo/AI starting endocrine tx TRIO 025 SNDX-275-062 Tissue acquisition CONTESSA (McAndrew) Phase II TRIO-US/UCLA Phase III oral DS8201-U303 Atezolizumab+/-Entinostat (Hurvitz) UCLA & TRIO-US paclitaxel+cape vs Ph 3 HER2 1+/2+ HR+ Up to 2 prior lines chemo for cape; <2 prior chemo TRIO-B11 (IST) DS8201 vs TPC (cape, MBC ok for MBC, no prior cape, LEADER Phase Ib portion eribulin, gem, vino, taxane) (Slamon) TRIO-US &UCLA unlimited endocrine tx Phase II ribo/endocrine Post-meno, 1st-line Must have had prior ET, (Glaspy/WAM) Pre/post-meno copanlisib/letroz/palbo CDK4/6i, 1-2 prior chemo UCLA Only Continous vs 3 on/1 off (Hurvitz) UCLA & TRIO-US IMMU-132-05 Ph 3 Sacituzumab Govit. Vs TPC Pts eligible if <10 years UCLA (LH, Torr, Alham, (McAndrew) from dx After 2 prior lines for MBC Pasadena, Valencia, CBBA (Hurvitz) (Hurvitz) Irvine, Burbank, WV) Phase I Abema/PI3Ki/Letrozole UCLA Only (Pasadena, UCLA & TRIO-US ER+ post-meno, 1st-line Burbank, Alhambra,LH) (Peddi) TRIO-030 ODM MORPHEUS (C039611) UCLA Only (LH, Torrance, Main) Call for slot first! SGNLVA-001 TNBC Phase Ib/II, ER+ post-meno Phase Ib Dose Expansion LIV1- Window of Opportunity Atezolizumab ipatasertib ADC Tumor >1.0 cm, 14-21 combos C3661001 Requires exactly 1 prior lines 2nd-line, no prior fulvestrant or Ph I ER+ post-meno, after CDK4/6i days AR inhibitor systemic tx (immune tx, chemo) chemo; must have had CDK4/6i; presurgically & 1-2 prior chemo; or TNBC up to 2 for MBC no bone only mets Open TRIO-US & prior chemo (Hurvitz) (Hurvitz) UCLA (LH, Pasadena, (Goldman) UCLA only (LH, Torr, Pasad, UCLA Only (LH, Pasadena, UCLA SM/WW Only: Call for slot Irvine, Burbank, WV, Ventura) Valencia, Burbank, WV) Main) (Slamon) 8/2018 GU CLINICAL TRIALS BLADDER STUDIES FIRST LINE METASTATIC STUDY: UPCOMING KIDNEY STUDIES AZ: NILE: Durvalumab plus chemo vs Durvalumab and tremelimumab plus chemo vs in cis ADJUVANT STUDY eligible/ineligible patients SATELLITES/TRIO US NETWORK ROCHE: Atezolizumab (anti-PDL1-inh) vs Obsevation post radical nephrectomy in high righ clear cell cancer. SECOND LINE METASTATIC STUDY

AZ: BISCAY: multiple combinations depending on FIRST LINE METASTATIC STUDY foundation medicine results done after prescreening. Those include Durvalumab plus mTORC 1/2, FGFRi, BMS: Nivolumab PLUS Cabozantinib or STAT3i, wee-1 kinase inhibitor, PARP inhibitor. vs Sunitinib in Previously Untreated, Patients need to be IO naïve. Met RCC TRIO US NETWORK SECOND/THIRD LINE METASTATIC STUDY

THIRD LINE METASTATIC STUDY CLOVIS: PARP inhibitor single agent oral agent after one or two lines of therapy CALITHERA: Phase 2 Study of CB-839 with Everolimus vs. Everolimus

FIRST/SECOND LINE STUDIES: UPCOMING PROSTATE STUDIES CRPC METASTATIC STUDIES PELOTON: HIF2 inhibitor + cabozantinib in first line or post IOs MERCK: pembro plus olaparib vs pembro plus docetaxel & steroid UPCOMING vs pembro plus enzalutamide ELI LILLY: Abiraterone& prednisone with or without CDK 4/6 inhibitor in CRPC For any questions/potential pts, please contact A.Drakaki vs pembro plus abiraterone in CRPC SATELITTES/TRIO US NETWORK [email protected], 3102066766 p29502 Prior tx determines which cohort patients will be getting into. THANK YOU FOR SUPPORTING OUR STUDIES Ovarian, Endometrial and Cervical Cancer Studies

Phase I Studies Rgenix RGX-104-001 Advanced Solid Malignancies (PI Chmielowski) - A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies including ovarian cancer (CRC: [email protected] ) Astellas ASP8374 (PI Hu-Lieskovan) - A Phase 1b Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Including Ovarian Cancer. ASP8374 is anti-TIGIT. (CRC: [email protected] ) F Star FS118-1701 (PI Hu-Lieskovan) - A Phase 1, Open-Label, Dose-Escalation, and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Patients With Advanced Malignancies That Have Progressed On or After Prior PD-1/PD-L1 Containing Therapy. (Including ovarian, endometrial and cervical cancer. CRC: [email protected] ) Mesothelin ADC With Doxil (PI Memarzadeh) - Phase 1b Study of Anetumab Ravtansine in Combination With Doxil in Patients With Recurrent Mesothelin-expressing Platinum- resistant Ovarian Cancer. (Subjects with mesothelin-expressing platinum-resistant ovarian cancer, CRC [email protected] ). SY-1365-101 (PI Konecny) (to open 11/18) - A Phase 1 Study of SY-1365, a Selective CDK7 Inhibitor, in Adult Patients with Advanced Solid Tumors including Ovarian Cancer. (Ovarian cancer previously treated with ≥ 3 prior lines of therapy, CRC TBD).

Phase II Studies BMS CheckMate 627 (PI Glaspy) - An Open-label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies including Vulvar, Cervical and Vaginal Cancer. (CRC: [email protected] ) Xenetic VX-EC-2-02 Endometrial (PI Konecny) - A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod with Progestin Therapy in Patients with Endometrial Cancer. (CRC: [email protected] ) Tesaro 4010-01-001 Endometrial (PI Konecny) - A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 , in Patients with Advanced Endometrial Cancer. (Patients with MSI-H or MSS endometrial cancer after at 1 - 2 lines of therapy, CRC [email protected] ). Tesaro 3000-02-004 Ovarian (PI Konecny) - Frontline Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab. (CRC: [email protected]). TRIO 026 Women's Cancers (PI Glaspy) - Phase II Randomized Study of Pembrolizumab with or without Epigenetic Modulation with CC-486 in Patients with Platinum Resistant Ovarian Cancer. (Platinum refractory/resistant disease, CRC: [email protected] ) OPAL (PI Konency) (to open in 11/18) - Phase II study of TSR-042 (PD1 mAB), Bevacizumab and Niraparib in Patients with PARPi naïve or PARPi Pretreated Recurrent Ovarian Cancer. (Platinum resistant disease, up to 4 prior lines for recurrent disease, if prior PARPi treatment then at least for 6 months). FORWARD II - Study of Mirvetuximab Soravtansine in with Bevacizumab and Carboplatin in Adults With FRa + Adv. Ovarian Cancer. (Max. 2 prior treatments, confirmed folate receptor positive expression by IHC ≥ 50% 2+, platinum sensitive disease, CRC [email protected]). Phase III Studies KEYNOTE-775 (PI Konecny) (to open in 11/18) - A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer. (max. 1 prior systemic anticancer regimen (other than adjuvant or neoadjuvant) for advanced, recurrent, or metastatic EC) GOG 3015 (PI Cohen) - Frontline Phase III, Randomized Study of Atezolizumab versus Placebo in Combination with Paclitaxel, Carboplatin and Bevacizumab for Patients with Newly Diagnosed Ovarian Cancer. (Sub-optimally debulked ovarian cancer or receiving neoadjuvant chemotherapy, CRC [email protected]).

UCLA Multiple Myeloma Clinical Trials

Transplant ≥2 lines of therapy >3 lines of therapy

BioLineRx-8040 Abbvie M13-494 Actinium AC225-MM01 Mobilization Trial for Venetoclax/dex vs Anti-CD33 alpha Autologous Stem pomalidomide /dex particle Cell Transplant BMS CA209-602 KCP-330 Selinexor in Nivolumab, , combination with Smoldering MM pom, dex backbone therapies

Janssen SMM3001: KITE-585-501 Anti- Dara sc vs Celgene bb2121-MM-003 BCMA CAR T-cell observation bb2121 vs triplet therapy NY-ESO TCR Modification of stem cells and T cells with the TCR TRIO US

Juno JCARH125 Anti- In start up BCMA CAR T-cell Trials in Hematological Malignancies AML ALL Myeloproliferative NEWLY DIAGNOSED RELAPSED/REFRACTORY Disease Any Age - Chimeric Antigen Receptor T-Cells - Gilteritinib– Antagonist of FLT3 PREVIOUSLY UNTREATED in combination therapy (0201) Myelodysplasia - Ruxolitinib - Gilteritinib– Antagonist of FLT3 PREVIOUSLY TREATED - INCB050465 in combination in combination therapy (0103) - Imetelstat in refractory to ESA with Ruxolitinib for MF - AG-120 or AG-221 with HMA (on hold) - Inhibitor of BET proteins therapy - Antibody to CD47 (CPI-0610) for MF - AG120 in combination therapy - LSD1 inhibitor (009) - Rigosertib PI3K PLK inhibitor PREVIOUSLY TREATED - PLK1 inhibitor in combo therapy after HMA therapy - SL-401 Diphtheria toxin IL-3 Age >60 - MEDI4736 after HMA therapy fusion protein - BEAT AML (multiple drugs and - Ibrutinib and Aza combination - Pacritinib for previously regimen) therapy for untreated and new treated with Ruxolitinib - Anti-CXCR4 (Ulocuplumab) - Ruxolitinib vs. Anagrelide Hematopoietic RELAPSED/REFRACTORY Any Age Cell Transplant - Gilteritinib: an antagonist of Hemoglobinopathies GVHD - Gene therapy trials FLT3 for flt3-ITD-mutated AML - Itacitinib for first line Acute - Entospletinib – SYK inhibitor GVHD - FT2102 – IDH1 mutation inhibitor Neoplasia - Anti-ASCT2 (MEDI7247) - Haplo HSCT with T-lymphocyte - Anti-CD47 antibody depleted of alloreactive T-cells vs. - PLK1 inhibitor in combo therapy standard Haplo HSCT Age >60 - Cord Blood Expansion Trial - OX1222 vascular disruptive agent (Gamida) Lung Cancer Front Line Therapy / Maintenance / Supportive Care & Non-Interventional

Resectable NSCLC Metastatic NSCLC

Patient received EGFR and ALK wildtype Pre-surgical complete tumor resection GNE ML39236 LCMC III Squamous Non-squamous MET mutation High TMB EGFR mutant only only or high level (≥10 mut/MB) (Garon) Novartis amplification centrally tested Neoadjuvant/adj CACZ885T2301 AZ Novartis uvant (Garon) Neon NT-002 atezolizumab ADAURA CPDR001C2101 BMS Adjuvant (Garon) Novartis (Goldman) (Garon) CheckMate 817 canakinumab vs. NEO-PV-01 + CINC280A2201 AZD9291 PDR001 + (Goldman) placebo pembro + (Garon) Post surgical platinum-doublet Nivolumab + carbo/pem INC280 resection chemo

Local/Locally Advanced Mesothelioma Non-Interventional

Biphasic or Radiotherapy sarcomatoid Solid Malignancy histology Tissue Bank (Garon) Identifying Polaris Group predictors of POLARIS response to PD-(L)1 SBRT-RFA Hypofrac IGRT iSABR 2015-003 inhibitors in NSCLC (Lee) (Lee) SBRT for lung Radiotherapy w/ (Lee) (Olevsky) tumors near stereotactic boost Radiotherapy ± ADI-PEG-20 central airways durvalumab and chemo + pem/cis Yellow = TRIO-US White = UCLA Only Gray = currently not enrolling or spots not always available, check with UCLA Lung Cancer Second Line Therapy and Beyond

Non-Small Cell Lung Cancer Small Cell Lung Cancer

Aeglea CAEB1102-100B Targeted Immunotherapy (Chiemlowski) Co-ArgI-PEG

PD-(L)1 inhibitor MET NTRK naïve mutation or EGFR or high level fusion- HER2 positive HER2 exon positive amplification 20 insertion EGFR wildtype only Neon NT-001 EGFR Iovance IOV-LUN-201 (Hu- and Spectrum Pfizer LOXO- (Garon) Lieskovan) ALK SPI-POZ-202 C0541001 Mirati Vaccinex Neovax + TRK-15002 TILs +/- wildtype (Goldman) (Rosen) MRTX-500 VX15-2503-04 durvalumab Nivolumab (Rosen) Poziotinib PF-06804103 (Garon) (Goldman) Larotrectinib PD-1/PD-L1 inhibitor Multiple combos VX2503-04 + Novartis was most recent with nivolumab Avelumab therapy CINC280A2201 (Garon) INC280 Dose Escalation/Dose Expansion Combinations

ARRAY Infinity 382-201 IPI-549-01 (Goldman) (Chmielowski) ARRY382 + IPI-549 + pembro nivolumab Dynavax CytomX Pfizer Daiichi Sankyo DV9-NSC-01 CTMX-M- B9991004 DS1062-A-J101 Pfizer (Garon) 2009-001 (Ribas) (Lisberg) Mirati Medimmune B0601002 DV281 + (Rosen) Avelumab + MRTX-500 D6060C00002 (Hu- DS1062-a nivolumab CX-2009 immunotherapies (Garon) (Goldman) Lieskovan) Multiple combos MEDI0562 + PF-04518600 with nivolumab tremelimumab + PF- Yellow = TRIO-US 05082566 NEKTAR Incyte Roche WP29945 Pfizer B8011001 White = UCLA Only 16-214-02 INCB59872-101 (Goldman) Anti PD-1 (Hu-Lieskovan) Gray = currently not enrolling or (Schiller) (Hu-Lieskovan) NKTR-214 + RO6958688 + spots not always available, check INCB059872 with UCLA nivolumab atezolizumab PF-06801591 Lung Cancer Immunotherapy

Frontline Metastatic Second line therapy or beyond

NSCLC NSCLC

EGFR and ALK wildtype

PD-(L)1 PD-1/PD-L1 inhibitor inhibitor Squamous Non-squamous High TMB was most recent naïve only only (≥10 mut/MB) therapy centrally tested EGFR Novartis NEON NT-002 wildtype only Iovance Neon NT-001 CPDR001C2101 (Garon) BMS IOV-LUN- (Hu- (Garon) NEO-PV-01 + CheckMate 817 201 Lieskovan) PDR001 + pembro + (Goldman) Mirati ARRAY Infinity Vaccinex (Garon) Neovax + platinum-doublet carbo/pem Nivolumab + MRTX-500 382-201 IPI-549-01 VX15-2503-04 TILs +/- Nivolumab chemo Ipilimumab (Garon) (Goldman) (Chmielowski) (Goldman) durvalumab Multiple ARRY382 + VX2503-04 + IPI-549 + combos with pembro Avelumab nivolumab nivolumab

Pfizer Early Stage Disease Mirati Medimmune B0601002 MRTX-500 D6060C00002 (Hu- (Garon) (Goldman) Lieskovan) Multiple combos MEDI0562 + PF-04518600 NSCLC with nivolumab tremelimumab + PF- 05082566 Dose Escalation/Dose Expansion Combinations

Pre-surgery Post-surgery Inoperable NEKTAR Dynavax Pfizer B8011001 16-214-02 DV9-NSC-01 Anti PD-1 (Hu-Lieskovan) (Garon) (Hu-Lieskovan) GNE ML39236 Novartis DV281 + NKTR-214 + LCMC III CACZ885T2301 iSABR nivolumab PF-06801591 nivolumab (Garon) (Garon) (Lee) Neoadjuvant/adj Adjuvant Radiotherapy ± uvant canakinumab vs. durvalumab Incyte atezolizumab placebo CytomX Pfizer B9991004 Roche WP29945 INCB59872- CTMX-M-2009-001 (Ribas) (Goldman) 101 Avelumab + Yellow = TRIO-US (Rosen) (Schiller) RO6958688 + immunotherapies White = UCLA Only CX-2009 INCB059872 atezolizumab Gray = currently not enrolling or spots not always available, check with UCLA Version: 27-Aug-2018 In start up TRIO - US trial

DLBCL DLBCL MZL Hodgkin 1st line Relapsed (cont.) Relapsed Relapsed BMS CA224-022 ZUMA-7 INCYTE CITAδEL-204 Celgene - High risk DLBCL Anti-LAG3 +/- Nivolumab R-CHOP + CC-122 KTE-C19 CAR T-cells INCB050465 (PI3K-δ inhib) 2nd line High Risk rel DLBCL (pleiotropic pathway modifier) BMS CA209-812 (GCB/ABC) Multiple NHL Nivolumab + BVed vs. BVed ZUMA-11 KTE-C19 CAR T-cells POLARIX Valor IGN001-101 CLL/SLL + 4-1BB agonistic Ab Anti-CD20/IFN-α fusion prot Relapsed R-CHPola vs R-CHOP (CD20+ B-cell NHL: DLBCL, FL, Miragen MRG 106-11-101 (anti-CD79b ADC) Incyte INCB-53914-201 MCL, t-DLBCL, PMBCL) MRG1106 (target: miR-155) (GCB/ABC) PI3K inhib + PIM-inhib (CTCL, CLL, DLBCL) KITE ZUMA-5 Atara EBV-CTL KTE-C19 CAR T-cells Oncternal Therapeutics Relapsed Allogeneic EBV-CTLs iNHL (FL, MZL) Cirmtuzumab + Ibrutinib (EBV-associated LPD) ROR1 moAb + BTK inhib PCYC 1123 (CLL/SLL, MCL) Ibrutinib + Lenalidomide Miragen MRG 106-11-101 FL (target: miR-155) +/- (ABC) st MRG1106 1 line (CTCL, CLL, DLBCL) KITE ZUMA-8 PCYC-1141 FL KTE-C19 CAR T-cells CLL KCP-330-009 Rituximab +/- Ibrutinib Regeneron R1979-ONC-1504 Selinexor 1. R2810 (anti PD-1) (iNHL) (SINE™ XPO1 antagonist) Relapsed 2. R2810 + R1979 (anti-CD20 x Relapsed PTCL (DLBCL - GCB/ABC, anti-CD3) (iNHL, aNHL) no t-DLBCL) KITE ZUMA-5 Portola KTE-C19 CAR T-cells Cerdulatinib (PRT062070) TG Thx (UNITY-NHL) (SYK/JAK inhibitor) Incyte INCB-53914-101 MCL Pending: PIM-kinase inhibitor 1st line Umbralisib/ CerRx 130002 (DLBCL) (FL, MZL) Fenretinide Acerta ACY-LY-308 Pending: BR +/- ACP-319 Umbralisib Verastem 225 PTCL Novel BTK inhibitor Novartis (BELINDA) (MCL) Duvelisib (PI3K-γ/δ inhib) CTL019 CAR T-cells 2nd line High Risk rel DLBCL Relapsed Merck Relapsed CTCL (Pembro + STING agonist) KITE ZUMA-2 Miragen MRG 106-11-101 CAR T-cells (B-cell or T-cell NHL, Solid CA) Acerta-Ly-111 (PRISM) KTE-C19 MRG1106 Acalabrutinib + AZD9150 (targets miR-155) (STAT3 inhib) PCYC 1143 Curis CA-4948 Acalabrutinib + AZD6738 Ibrutinib + Venetoclax IRAK4 inhibitor Portola Cerdulatinib (ATR inhib) BTK + Bcl-2 inhibition (NHL) (SYK/JAK inhibitor) 2018 UCLA SARCOMA STUDIES

SARCOMA SUBTYPE STUDY PI

GIST Randomized Phase 2 Study Of Nivolumab Monotherapy versus Nivolumab Combined With Ipilimumab In Patients With Singh Metastatic or Unresectable GIST

Soft Tissue Sarcomas Phase 1b/2 of GEM/TAX +/- For Soft Tissue Sarcoma Chmielowski Leiomyosarcoma, Synovial A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Chmielowski Sarcoma, Alveolar Soft Parts Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma Sarcoma Synovial Sarcoma A Phase 3, Randomized, Double blind, Placebo controlled Study to Determine the Efficacy and Safety of CMB305 in Singh Unresectable Locally advanced or Metastatic NY ESO 1+ Synovial Sarcoma Subjects Following First line Systemic Anti Cancer Therapy Dedifferentiated Liposarcoma Double Blind Study of Selinexor versus Placebo in Patients with Advanced, Unresectable Dedifferentiated Liposarcoma Chmielowski

Ewing Sarcoma Dose Escalation Study of TK216 in Patients with Relapsed or Refractory Ewing Sarcoma Federman

Soft Tissue Sarcomas A Phase 1b/2 Dose-Escalation and Expansion Trial of NC-6300 (Nanoparticle Epirubicin) in Patients with Advanced Solid Singh Tumors or Advanced, Metastatic, or Unresectable Soft Tissue Sarcoma GIST An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Singh Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST) GIST Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Rosen Therapies (invictus) Chordoma A Signal Finding Phase 2 Study Of Nivolumab (anti-PD-1; BMS-936558; ONO-4538) and Relatlimab (Anti-LAG-3 Singh Monoclonal Antibody; BMS-986016) In Patients With Advanced Chordoma

Arun Singh : [email protected] (310)-586-2095 Bartosz Chmielowski : [email protected] (310)-829-5471 Hepatobiliary Studies Cholangiocarcinoma HCC Front-line Front-line • Phase 3 IMBRAVE 150 Atezo+Bev vs • Gem/Cis + PEGPH20 Sorafenib (+Atezolizimab) • Phase 2 Lenvatinib+pembro

Beyond first-line Beyond first-line • BGJ398 for FGFR- • extension study, second- translocated tumors line after other first line than sorafenib • H3b FGFR TKI (FGF19 • Adaptimmune SPEAR-T expressing) • H3B FGFR4 TKI (FGF19+) • Pieris bi-specific antibody (HER2 amplified) Post-resection • Phase 3 Nivolumab vs placebo UCLA trials for SCCHN – Newly diagnosed – curative intent treatment HPV+ TORS candidate: Locally advanced P16+ CUP ok T0-3 amenable to R0 resection Surgical Candidate? N0-N2b - all cervical disease confined to 2 cervical lymph node levels if the involved nodal levels are adjacent

Preop SBRT + durvalumab+/- YES NO tremelimumab  TORS +/- MRND  adjuvant durvalumab (opening July 2018?) Platinum Eligible: Platinum Ineligible: P16 neg OP or Larynx, hypopx, OC -Age>70yrs Adjuvant – Phase III – WO40242 Stage III/IV - Hearing loss (80dB threshold) OP P16+ Stage III (T4 or N3) Atezolizumab vs. placebo - Renal insufficiency (Crcl 30- MERCK3475-412: Phase III High risk SCCHN after multi- 60ml/min) Cisplatin 100mg/m2 q3wk –RT P16 neg OP or Larynx, hypopx, OC modality definitive treatment +/- Pembrolizumab Stage III/IV (surgery  adjuvant RT/chemo- P16+ OP Stage III (T4 or N3) or RT, Also allows Stage II (T3 N0-2, N2 T0-3) if >20 pk yr definitive chemo-RT +/- salvage P16+ OP Stage II (T3 N0-2, N2T0-3) if BMS209-99TM: neck dissection) >20 pkyr: cetuximab + Nivo placebo-RT vs. Completed CRT with at least BMS209-99TM: Phase III cetux placebo + nivolumab-RT Stable disease on post treatment Cisplatin 100mg/m2 q3wk-RT (blinded)  nivo vs. placebo PET/CT +/- nivolumab Open in TRIO-US Network Open in TRIO-US Network (9/5/18) UCLA trials for SCCHN – Recurrent/metastatic Local/Loco-regional Recurrent/Metastatic - Unresectable Surgically Resectable - No plan for further adjuvant RT Non-immunotherapy UCSD/UCLA MISP52210 Phase II HRAS mutant SCCHN pembro/placebo (3:1 randomization) 3- Oral tipifarnib BID 6 weeks pre-op  surgical resection  Also open for HRAS mutant ALL patients receive adjuvant SCC any histology pembrolizumab x12 months Immunotherapy CytomX Checkpoint inhibitor naive: CX2009 (ADC targeting Checkpoint inhibitor experienced CD166) CD166+ on prescreening AZ Scores (PI: Rosen) Frontline (chemo-naïve in R/M setting) IPI549 AZD9150 (STAT 3 inhibitor) + CPI pretreated with PD1 as most recent UCSD/UCLA HRPP line of therapy or MDSC high on durvalumab prescreening 160621: IPI-549 (oral PI3Kgamma, inhibits Cetuximab + Pembrolizumab– MDSCs)+ nivolumab Prior checkpoint inhibitor ok Pfizer B9991004 (PI: Chmielowski) Prior cetuximab ok Up to 2 prior lines NPC, SCC skin primary ok Checkpoint inhibitor naïve (opening Fall 2018) OX40+anti-CD137+ avelumab Injectable tumor: (PI: Ribas) Dynavax – SD101 intratumoral injection + Pembrolizumab Prior checkpoint inhibitor ok (9/5/18) UCLA trials for SCCHN – Other

Supportive Care studies for Chemo-RT patients: Chemoprevention: Pembrolizumab for Soylent meal replacement for chemo-RT patients with excessive weight loss (Rad Onc) Leukoplakia (phase II) leukoplakia, erythroleukoplakia or proliferative verrucous leukoplakia (PVL) Mucositis prevention study for chemo-RT At least 1 lesion measurable in 2 patients receiving platinum-RT dimensions that can be followed on study (opening Fall 2018) Moderate or severe dysplasia or CIS Pembrolizumab 200mg IV q3 wks x6 months. Thyroid: (Opening Fall 2018)

BMS209-627 Nivolumab open label - Medullary thyroid ca - Anaplastic thyroid cancer

(9/5/18)