ClinicalTrials.gov Identifier: NCT Adi Diab 1, Nizar Tannir 1, Daniel Cho
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1 Pivot-02: Preliminary safety, efficacy and biomarker results from dose escalation of the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic melanoma, renal cell carcinoma and non-small cell lung cancer ClinicalTrials.gov Identifier: NCT Adi Diab 1, Nizar Tannir 1, Daniel Cho Adi 2, Vali Papadimitrakopoulou Diab, MD, 1, Chantale Bernatchez MD Anderson 1, Cara Haymaker 1, Salah Eddine Bentebibel Cancer Center 1, Brendan Curti 3, Michael Wong 1, Scott Tykodi 4, Igor Puzanov 5, Ira Smalberg 6, Ivan Gergel 7, Mary Tagliaferri 7, Jonathan Zalevsky 7, Ute Hoch 7, Sandra Aung 7, Michael Imperiale 7, Wendy Clemens 8, Harriet Kluger 9, Michael Hurwitz 9, Patrick Hwu 1, Mario Sznol 9 1 The University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2 NYU Medical Oncology Associates, New York, NY, USA; 3 Providence Cancer Center and Earle A. Chiles Research Institute, Portland, OR, USA; 4 University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA; 5 Roswell Park Cancer Institute, Buffalo, NY, USA; 6 Imaging/Radiology Consultant, Los Angeles, CA,USA; 7 Nektar Therapeutics, San Francisco, CA, USA; 8 Bristol-Myers Squibb, New York, NY, USA; 9 Yale School of Medicine, New Haven, CT, USA 1
2 Presenter Disclosure Information Dr. Adi Diab, MD Anderson Cancer Center The following relationships exist related to this presentation: Research funding (institution): Nektar Therapeutics and Bristol-Myers Squibb 2
3 NKTR-214 Background: Harnessing the IL-2 Pathway to Increase TILs Prodrug (inactive) NKTR-214 prodrug design with sustained signaling Q2W or Q3W Dosing Mitigation of rapid immune stimulation to achieve safe, outpatient regimen Biased signaling preferentially activates and expands effector T cells and NK cells over Tregs in the tumor microenvironment Increases proliferation of TILs and PD-1 expression on effector T cells in the tumor microenvironment 3
4 Clinical and Preclinical Rationale for Combination of NKTR Anti-PD-1 NKTR-214 Monotherapy Clinical Trial 1 NKTR Anti-PD-1 Preclinical Data 2 PD-1 Expression on CD8 T Cells in Blood CD8 / Treg Ratio in Tumor 1600 CT26 Mouse Colon Tumor Model Ki67+ CD8 + K i67 + PD -1 + (% CD8) C1D1 N=10 patients Day C1D8 Fold-Change from Baseline CD8 Tregs Fold change expressed as Week 3 / pre-dose Shown are results from N=10 patients Q3W dose schedules Mean Tumor Volume (m m 3 ± SEM) treatment duration Vehicle A nti-c TLA-4 A nti-pd -1 NKTR-214 A nti-c TLA -4 + A nti-p D -1 NKTR Anti-PD Blood: Increase in newly proliferating (Ki67+) PD-1+ CD8 T cells Tumor: Increase in total T cells, NK and CD8+ T cells with no increase in Tregs, increase in newly proliferating (Ki67+) PD-1+ CD8 T cells Days NKTR-214 dosed 0.8 mg/kg q9dx3, anti-pd-1 or anti-ctla-4 dosed 200ug or 100ug 2x/week respectively. 1. Abstract No: 2545 (Board #37) ASCO 2017; 2. Abstract (169221): ASCO
5 PIVOT-02 Dose Escalation Patients Phase 1b (N=38) IO Treatment-Naïve MEL 1L (with known BRAF status) (N=11) RCC 1L, 2L (N=22) NKTR mg/kg Q3W + NIVO 240 mg Q2W N=4 RP2D NSCLC 1L, 2L (EGFR & ALK WT) (N=5) Confirmed locally advanced or metastatic solid tumors Measurable disease per RECIST 1.1 ECOG 0 or 1 NKTR mg/kg Q2W + NIVO 240 mg Q2W N=3 NKTR mg/kg Q2W + NIVO 240 mg Q2W N=3 NKTR mg/kg Q3W + NIVO 360 mg Q3W MAD N=22 Adequate organ function Fresh biopsy and archival tissue NKTR mg/kg Q3W + NIVO 360 mg Q3W N=3 NKTR mg/kg Q3W + NIVO 360 mg Q3W Dose Limiting Toxicities (N=2) 5 N=3
6 PIVOT-02 Dose Expansion Underway in 13 Cohorts MEL 1L IO naïve Phase 2 (N= ~330) N= per cohort MEL 2/3L IO R/R RP2D RCC 1L RCC 2/3L IO naïve IO R/R NSCLC 1L PD-L1 50% NSCLC 1L PD-L1 <1% NKTR mg/kg Q3W + NIVO 360 mg Q3W NSCLC 1L IO naïve NSCLC 1L PD-L1 1% to <50% N=22 NSCLC 2L NSCLC 2/3L UC (Bladder) 1L UC (Bladder) 2/3L IO naïve IO R/R IO naïve IO R/R NSCLC 2L PD-L1 <1% UC 1L UC 1L Cisplatin-ineligible R/R: progressed on Anti-PD-(L)1 TNBC 1/2L IO naïve 6
7 Study Assessments Data cutoff: November 2, 2017 Efficacy Response was assessed by investigator every 8 (+/- 1) weeks per RECIST v1.1 and immune-related RECIST (irrecist) Per protocol, efficacy-evaluable is defined as patients with 1 post baseline scan Safety and tolerability Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Safety-evaluable includes 1 dose of study treatment Biomarker exploratory analyses Baseline tumor PD-L1 status by tumor type Longitudinal sampling of blood and tumor biopsies to be presented at a future conference 7
8 Dose Escalation: Patient Demographics and Disease Characteristics Total (N=38) Melanoma (N=11) RCC (N=22) NSCLC (N=5) Sex Male 30 (78.9%) 7 (63.6%) 19 (86.4%) 4 (80.0%) Female 8 (21.1%) 4 (36.4%) 3 (13.6%) 1 (20.0%) Age (years) Median (Range) 61 (22-72) 62 (22-70) 61 (45-72) 58 (53-72) ECOG Performance Status 0 25 (65.8%) 8 (72.7%) 15 (68.2%) 2 (40.0%) 1 13 (34.2%) 3 (27.3%) 7 (31.8%) 3 (60.0%) Prior systemic therapy for metastatic disease 0 26 (68.4%) 11 (100%) 14 (63.6%) 1 (20.0%) 1 12 (31.6%) 0 8 (36.4%) 4 (80.0%) 8
9 Dose Escalation: Disease Characteristics BRAF status Melanoma (N=11) % Mutant V600E Wild-Type LDH at baseline* High Normal PD-L1 status** Positive 1% Negative <1% Stage M1a M1b M1c Liver metastases at baseline Yes No * Based on maximum value prior to dosing. ** Measured using either 28-8 or 22C3 assays on fresh or archival tumor with specific cutoffs. RCC (N=22) % 1L IMDC Score n=14 Favorable Intermediate Poor L PD-L1 status ** n=14 Positive 1% Negative <1% No available biopsy L PD-L1 status ** n=8 Positive 1% Negative <1% NSCLC (N=5) % Histologic Subtype Adenocarcinoma Squamous Smoker Yes No 0 0 PD-L1 status ** Positive 1% 0 0 Negative <1%
10 Dose Escalation: Disease Characteristics BRAF status Melanoma (N=11) % Mutant V600E Wild-Type LDH at baseline* High Normal PD-L1 status** Positive 1% Negative <1% Stage M1a M1b M1c Liver metastases at baseline Yes No * Based on maximum value prior to dosing. ** Measured using either 28-8 or 22C3 assays on fresh or archival tumor with specific cutoffs. RCC (N=22) % 1L IMDC Score n=14 Favorable Intermediate Poor L PD-L1 status ** n=14 Positive 1% Negative <1% No available biopsy L PD-L1 status ** n=8 Positive 1% Negative <1% NSCLC (N=5) % Histologic Subtype Adenocarcinoma Squamous Smoker Yes No 0 0 PD-L1 status ** Positive 1% 0 0 Negative <1%
11 Dose Escalation: Disease Characteristics BRAF status Melanoma (N=11) % Mutant V600E Wild-Type LDH at baseline* High Normal PD-L1 status** Positive 1% Negative <1% Stage M1a M1b M1c Liver metastases at baseline Yes No * Based on maximum value prior to dosing. ** Measured using either 28-8 or 22C3 assays on fresh or archival tumor with specific cutoffs. RCC (N=22) % 1L IMDC Score n=14 Favorable Intermediate Poor L PD-L1 status ** n=14 Positive 1% Negative <1% No available biopsy L PD-L1 status ** n=8 Positive 1% Negative <1% NSCLC (N=5) % Histologic Subtype Adenocarcinoma Squamous Smoker Yes No 0 0 PD-L1 status ** Positive 1% 0 0 Negative <1%
12 PIVOT-02: Best Percent Change in Target Lesions by Tumor Type and Dose (n=36) Best % Change in Tumor Size from Baseline NKTR mg/kg Q3W 26/36 (72%) Reduction in Target Lesions * Best overall response is PD (SD for target lesions, PD per non-target lesions) # Best overall response is SD (PR for target lesions, PD per new lesion at confirmatory scan) Tumor Histology + Best overall response is PR (CR for target lesions, non-target lesions still present) Data are shown for patients with post-baseline scans that included assessment of target lesions. Two patients not included in the figure: one patient discontinued from study due to clinical progression before the first post-baseline tumor assessment and one patient on treatment does not have a post-baseline scan. 12
13 Stage IV Treatment-Naïve Melanoma Patients (N=11) Best Overall Response by RECIST*: ORR=7/11 (64%); DCR=10/11 (91%) Best Overall Response by irrecist: ORR=8/11 (73%); DCR=10/11 (91%) % Change From Baseline in Target Lesions % Change in Target Lesions Over Time Best % Change in Tumor Size from Baseline Change in Tumor Size (%) from Baseline Median TTR 1.7 mos Weeks Since Treatment Initiation Horizontal dotted lines indicate the thresholds for PD and response according to RECIST (version 1.1) criteria. # Best Overall Response is SD (PR for target lesions, PD per new lesion on confirmatory scan) + Best Overall response is PR (CR for target lesions, non-target lesions still present) *One patient in ORR calculation has unconfirmed PR. 13
14 Time to and Duration of Response Stage IV Treatment-Naïve Melanoma All patients with responses (7/7) are still on treatment Patients With Disease Control RECIST 1.1 Criteria + + Best Overall response is PR (CR for target lesions, non-target lesions still present) Time on Study (Weeks) 14
15 Stage IV Treatment-Naïve 1L Renal Cell Carcinoma (N=13) Efficacy-evaluable patients with 1 or 2 post baseline scans Best ORR by RECIST 1 post baseline scan: ORR=6/13 (46%); DCR=11/13 (85%) Best % Change in Tumor Size from Baseline % Change From Baseline in Target Lesions PD-L1 Negative Change in Tumor Size (%) from Baseline % Change in Target Lesions Over Time Median TTR 1.9 mos Weeks Since Treatment Initiation Horizontal dotted lines indicate the thresholds for PD and response according to RECIST (version 1.1) criteria. * Best overall response is PD (SD for target lesions, PD per non-target lesions). 15
16 Stage IV Treatment-Naïve 1L Renal Cell Carcinoma (N=13) Efficacy-evaluable patients with 1 or 2 post baseline scans Best ORR by RECIST 1 post baseline scan: ORR=6/13 (46%); DCR=11/13 (85%) Best ORR by RECIST 2 post baseline scans: ORR=6/10 (60%); DCR=8/10 (80%) Best % Change in Tumor Size from Baseline % Change From Baseline in Target Lesions PD-L1 Negative Change in Tumor Size (%) from Baseline % Change in Target Lesions Over Time 2 Scans 1 ucr 5 PR 2 SD 2 PD** Median TTR 1.9 mos Weeks Since Treatment Initiation Horizontal dotted lines indicate the thresholds for PD and response according to RECIST (version 1.1) criteria. * Best overall response is PD (SD for target lesions, PD per non-target lesions). **Includes PD with 1 post base-line scan 16
17 Time to and Duration of Response Stage IV Treatment-Naïve Renal Cell Carcinoma 1L (CR, PR or SD) All patients with disease control (11/13) are still on treatment Patients With Disease Control RECIST 1.1 Criteria Time on Study (Weeks) 17
18 Stage IV IO-Naïve PD-L1 Negative NSCLC (1L and 2L) Best Overall Response by RECIST (2L): ORR=3/4 (75%); DCR=3/4 (75%) Best Overall Response by RECIST (1L and 2L): ORR=3/5 (60%); DCR=3/5 (60%) % Change From Baseline in Target Lesions % Change in Target Lesions Over Time Best % Change in Tumor Size from Baseline 1L Change in Tumor Size (%) from Baseline Median TTR (2L) 1.7 mos Horizontal dotted lines indicate the thresholds for PD and response according to RECIST (version 1.1) criteria. Weeks Since Treatment Initiation 18
19 Best Overall Response by RECIST 1.1 as of November 2, 2017 Patients Stage IV Treatment- Naïve Melanoma (N=11) Stage IV Treatment-Naïve 1L RCC (N=14) Patients with at least one or more scans Patients with at least two or more scans or PD** 2L RCC (N=8) 1L NSCLC (N=1) Total Evaluable L NSCLC (N=4) ORR (CR+PR) 7 (64%) + 6 (46%) 6 (60%) 1 (14%) 0 (0) 3 (75%) CR 2 (18%) 1 (8%) # 1 (10%) # (25%) # PR 5 (45%) 5 (38%) 5 (50%) 1 (14%) 0 2 (50%) SD 3 (27%) 5 (38%) 2 (20%) 6 (86%) 1 (100%) 0 DCR (CR+PR+SD) 10 (91%) 11 (85%) 8 (80%) 7 (100%) 1 (100%) 3 (75%) PD CR, complete response; DCR, disease control rate; ORR, objective response rate; PR, partial response; PD, progressive disease; SD, stable disease + CR is waiting to be confirmed for 1 of 2 patients with CR; one patient in calculation has upr. # PR for patient confirmed. CR is waiting to be confirmed. ** Patients with at least 2 post-baseline scans or progressed on 1 st post-baseline scan. 19
20 Treatment-Related AEs Total (N=38) NKTR q3w + Nivo 360 (N=25) NKTR q3w + Nivo 240 (N=4) NKTR q2w + Nivo 240 (N=3) NKTR q2w + Nivo 240 (N=3) NKTR q3w + Nivo 360 (N=3) Preferred Term [1] Grade 3 or 4 4 (10.5%) 1 (4.0%) 1 (25.0%) (66.7%) Acidosis 1 (2.6%) (33.3%) Arthralgia 1 (2.6%) 0 1 (25.0%) Diarrhea 1 (2.6%) (33.3%) Hyperglycemia 1 (2.6%) (33.3%) Hyperthyroidism 1 (2.6%) (33.3%) Hyponatraemia 1 (2.6%) 1 (4.0%) Hypotension 1 (2.6%) (33.3%) Syncope 1 (2.6%) 1 (4.0%) Grade 1&2 (>25%) Fatigue 28 (73.7%) 17 (68.0%) 4 (100.0%) 2 (66.7%) 3 (100.0%) 2 (66.7%) Flu Like Symptoms** 26 (68.4%) 15 (60.0%) 3 (75.0%) 3 (100.0%) 2 (66.7%) 3 (100.0%) Rash* 23 (60.5%) 13 (52.0%) 4 (100.0%) 1 (33.3%) 2 (66.7%) 3 (100.0%) Pruritus 16 (42.1%) 8 (32.0%) 2 (50.0%) 2 (66.7%) 2 (66.7%) 2 (66.7%) Headache 14 (36.8%) 8 (32.0%) 3 (75.0%) 1 (33.3%) 1 (33.3%) 1 (33.3%) Nausea 14 (36.8%) 8 (32.0%) 3 (75.0%) 1 (33.3%) 0 2 (66.7%) Diarrhea 12 (31.6%) 8 (32.0%) 2 (50.0%) 0 1 (33.3%) 1 (33.3%) Arthralgia 11 (28.9%) 6 (24.0%) 3 (75.0%) 1 (33.3%) 0 1 (33.3%) Decreased Appetite 10 (26.3%) 3 (12.0%) 3 (75.0%) 2 (66.7%) 0 2 (66.7%) (1) Patients are only counted once under each preferred term using highest grade * Rash includes the following MedDRA preferred terms: Rash, rash erythematous, rash macular and rash maculo-popular; ** Flu-like symptoms includes the following MedDRA preferred terms: influenza-like illness, pyrexia, and chills. AEs occurred in same patient, patient was dose reduced to NKTR mg/kg + nivo 360 mg q3w and patient continues on treatment with ongoing confirmed PR No study discontinuations due to TRAEs No treatmentrelated deaths No G3/4 immunemediated AEs at RP2D and lower 20
21 Conclusions NKTR-214 plus nivolumab is a novel combination of immuno-oncology agents with differentiated, complementary and non-overlapping mechanisms of immune activation Efficacy results demonstrate important clinical activity in both PD-L1 negative and positive patients All patients with responses continue on treatment Few patients experienced rapid progression on treatment Melanoma 1 st line: ORR 64% (2 CR, 5 PR), DCR 91%, mttr 1.7 mos RCC 1 st line: ( 1 scan) ORR 46% (1 CR, 5 PR), DCR 85%, mttr 1.9 mos; ( 2 scans) ORR 60%, DCR 80% NSCLC 2 nd line (PD-L1 Negative): ORR 75% (1 CR, 2 PR), DCR 75%, mttr 1.7 mos NKTR-214 plus nivolumab is safe and tolerable and can be administered as a convenient, outpatient regimen No study discontinuations due to TRAEs and no treatment related deaths NKTR-214 did not increase the risk for imaes associated with nivolumab RP2D established NKTR mg/kg plus nivolumab 360 mg IV Q3W Enrollment to 13 expansion cohorts is underway (N=~330) 21
22 Acknowledgments A special thank you is extended to the patients, their families and all study staff who are participating and have participated in the PIVOT-02 dose-escalation study and PIVOT expansion study MD Anderson Patrick Hwu, MD Nizar Tannir, MD Vali Papadimitrakopoulou, MD Michael Wong, MD Chantale Bernatchez, PhD Cara Haymaker, PhD Salah Bentebibel, PhD Yale University Mario Sznol, MD Michael Hurwitz, MD Harriet Kluger, MD Scott Gettinger, MD Providence Cancer Center Brendan Curti, MD New York University Daniel Cho, MD Roswell Park Cancer Institute Igor Puzanov, MD Seattle Cancer Center Scott Tykodi, MD 22
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