Neal Ready

Positions:

Professor of Medicine

Medicine, Medical Oncology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

Ph.D. 1983

University of California - Irvine

M.D. 1986

Vanderbilt University

Medical Resident, Medicine

Brown University

Fellow in Hematology-Oncology, Medicine

Brown University

Fellow in Hematology-Oncology, Medicine

Tufts University

Grants:

Evaluation of Tumor Infiltrating Lymphocytes in Resected Non Small Cell Lung Cancer

Administered By
Medicine, Medical Oncology
Awarded By
Lung Cancer Initiative of North Carolina
Role
Mentor
Start Date
End Date

Refining and Validating Genomic Signatures in Lung Cancer

Administered By
Institutes and Centers
Awarded By
National Institutes of Health
Role
Investigator
Start Date
End Date

Programs in Clinical Effectiveness of Cancer Pharmacogenomics

Administered By
Duke Center for Applied Genomics and Precision Medicine
Awarded By
National Institutes of Health
Role
Co Investigator
Start Date
End Date

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Stage I-III Limited Disease Small-Cell Lung Cancer

Administered By
Duke Cancer Institute
Awarded By
AstraZeneca LP
Role
Principal Investigator
Start Date
End Date

A MULTICENTER, OPEN-LABEL, PHASE 1B/2 STUDY TO EVALUATE SAFETY AND EFFICACY OF AVELUMAB MSB0010718C) IN COMBINATION WITH CHEMOTHERAPY WITH OR WITHOUT OTHER ANTI-CANCER IMMUNOTHERAPIES AS FIRST-LINE TREATMENT IN PATIENTS WITH ADVANCED MALIGNANCIES

Administered By
Duke Cancer Institute
Awarded By
Pfizer, Inc.
Role
Principal Investigator
Start Date
End Date

Publications:

Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer.

PURPOSE: Immunotherapy has revolutionized the treatment of advanced non-small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively. We report 5-year pooled efficacy and safety from these trials. METHODS: Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until progression or unacceptable toxicity. The primary end point for both trials was OS; secondary end points included progression-free survival (PFS) and safety. Exploratory landmark analyses were investigated. RESULTS: After the minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, 50 nivolumab-treated patients and nine docetaxel-treated patients were alive. Five-year pooled OS rates were 13.4% versus 2.6%, respectively; 5-year PFS rates were 8.0% versus 0%, respectively. Nivolumab-treated patients without disease progression at 2 and 3 years had an 82.0% and 93.0% chance of survival, respectively, and a 59.6% and 78.3% chance of remaining progression-free at 5 years, respectively. Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3-5 years of follow-up, seven of whom experienced new events; one (3.2%) TRAE was grade 3, and there were no grade 4 TRAEs. CONCLUSION: At 5 years, nivolumab continued to demonstrate a survival benefit versus docetaxel, exhibiting a five-fold increase in OS rate, with no new safety signals. These data represent the first report of 5-year outcomes from randomized phase III trials of a programmed death-1 inhibitor in previously treated, advanced NSCLC.
Authors
Borghaei, H; Gettinger, S; Vokes, EE; Chow, LQM; Burgio, MA; de Castro Carpeno, J; Pluzanski, A; Arrieta, O; Frontera, OA; Chiari, R; Butts, C; Wójcik-Tomaszewska, J; Coudert, B; Garassino, MC; Ready, N; Felip, E; García, MA; Waterhouse, D; Domine, M; Barlesi, F; Antonia, S; Wohlleber, M; Gerber, DE; Czyzewicz, G; Spigel, DR; Crino, L; Eberhardt, WEE; Li, A; Marimuthu, S; Brahmer, J
MLA Citation
Borghaei, Hossein, et al. “Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer.J Clin Oncol, vol. 39, no. 7, Mar. 2021, pp. 723–33. Pubmed, doi:10.1200/JCO.20.01605.
URI
https://scholars.duke.edu/individual/pub1472931
PMID
33449799
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
39
Published Date
Start Page
723
End Page
733
DOI
10.1200/JCO.20.01605

Targeting MET Amplification with Crizotinib in a Case of Sinonasal Undifferentiated Carcinoma.

Comprehensive molecular testing of individual tumors has led to the identification of novel molecularly defined cancer therapies and treatment indications. Given low frequencies of many molecular alterations, efficacy of therapies used to target them are often undefined, especially in the context of rare malignancies. Here we describe the first reported case of MET amplification in sinonasal undifferentiated carcinoma (SNUC), a rare cancer with a poor prognosis. The patient was treated with crizotinib, a tyrosine kinase inhibitor that targets c-MET, and experienced a complete response. Our report demonstrates the potential of employing precision oncology approaches in SNUC and other rare cancers.
Authors
Robinson, H; Green, M; Radkar, G; Ready, N; Strickler, J
MLA Citation
Robinson, Hannah, et al. “Targeting MET Amplification with Crizotinib in a Case of Sinonasal Undifferentiated Carcinoma.Cancer Invest, vol. 39, no. 3, Mar. 2021, pp. 235–39. Pubmed, doi:10.1080/07357907.2021.1884695.
URI
https://scholars.duke.edu/individual/pub1473779
PMID
33538211
Source
pubmed
Published In
Cancer Invest
Volume
39
Published Date
Start Page
235
End Page
239
DOI
10.1080/07357907.2021.1884695

A Phase 1-2 Study of Rovalpituzumab Tesirine in Combination With Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Extensive-Stage SCLC.

INTRODUCTION: This open-label, phase 1-2 study evaluated the safety and efficacy of rovalpituzumab tesirine (Rova-T), an antibody-drug conjugate targeting DLL3, plus immune checkpoint inhibitors nivolumab plus or minus ipilimumab in previously treated extensive-stage SCLC (ES SCLC). METHODS: Patients with histologically or cytologically confirmed, previously treated (two or more lines of therapy) ES SCLC were enrolled into two cohorts. Cohort 1 received 0.3 mg/kg Rova-T (once every 6 wk for two cycles) plus 360 mg nivolumab (two 3-wk cycles beginning on week 4). Cohort 2 received the same dosage of Rova-T as cohort 1 plus 1 mg/kg nivolumab (four 3-wk cycles) and 1 mg/kg ipilimumab (beginning week 4). Both cohorts received 480 mg nivolumab every 4 weeks starting at week 10. Key objectives were to evaluate safety and tolerability and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1). The response-related results are based on centrally read data. RESULTS: A total of 42 patients received therapy: cohort 1, n = 30; cohort 2, n = 12. Overall, 43% received two or more previous lines of therapy. All patients experienced one or more treatment-emergent adverse event (TEAE); 41 patients reported AEs considered related to the study drug by the investigator. The most frequent TEAE was pleural effusion (n = 20, 48%); most common grade greater than or equal to 3 was anemia (n = 9, 21%). Three grade 5 TEAEs considered related to the study drug were reported (cohort 1): pneumonitis (n = 2), acute kidney injury (n = 1). The objective response rate was 30% (12 of 40): cohort 1, 27.6% (8 of 29); cohort 2, 36.4% (4 of 11); all partial responses. CONCLUSIONS: Despite encouraging antitumor activity in previously treated ES SCLC, combination therapy with Rova-T and nivolumab plus or minus ipilimumab was not well tolerated at the dose levels and administration schedules evaluated.
Authors
Malhotra, J; Nikolinakos, P; Leal, T; Lehman, J; Morgensztern, D; Patel, JD; Wrangle, JM; Curigliano, G; Greillier, L; Johnson, ML; Ready, N; Robinet, G; Lally, S; Maag, D; Valenzuela, R; Blot, V; Besse, B
MLA Citation
URI
https://scholars.duke.edu/individual/pub1478167
PMID
33652156
Source
pubmed
Published In
J Thorac Oncol
Published Date
DOI
10.1016/j.jtho.2021.02.022

A phase I study of AT-101, a BH3 mimetic, in combination with paclitaxel and carboplatin in solid tumors.

Background AT-101 is a BH3 mimetic that inhibits the heterodimerization of Bcl-2, Bcl-xL, Bcl-W, and Mcl-1 with pro-apoptotic proteins, thereby lowering the threshold for apoptosis. This phase I trial investigated the MTD of AT-101 in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Methods Patients were treated with AT-101 (40 mg) every 12 h on days 1, 2 and 3 of each cycle combined with varying dose levels (DL) of paclitaxel and carboplatin [DL1: paclitaxel (150 mg/m2) and carboplatin (AUC 5) on day 1 of each cycle; DL2: paclitaxel (175 mg/m2) and carboplatin (AUC 6) on day 1 of each cycle]. Secondary objectives included characterizing toxicity, efficacy, pharmacokinetics, and pharmacodynamics of the combination. Results Twenty-four patients were treated across two DLs with a planned expansion cohort. The most common tumor type was prostate (N = 11). Two patients experienced DLTs: grade 3 abdominal pain at DL1 and grade 3 ALT increase at DL2; however, the MTD was not determined. Moderate hematologic toxicity was observed. One CR was seen in a patient with esophageal cancer and 4 patients achieved PRs (1 NSCLC, 3 prostate). PD studies did not yield statistically significant decreases in Bcl-2 and caspase 3 protein levels, or increased apoptotic activity induced by AT-101. Conclusion The combination of AT-101 at 40 mg every 12 h on days 1, 2 and 3 combined with paclitaxel and carboplatin was safe and tolerable. Based on the modest clinical efficacy seen in this trial, this combination will not be further investigated. Clinical Trial Registration: NCT00891072, CTEP#: 8016.
Authors
Stein, MN; Goodin, S; Gounder, M; Gibbon, D; Moss, R; Portal, D; Lindquist, D; Zhao, Y; Takebe, N; Tan, A; Aisner, J; Lin, H; Ready, N; Mehnert, JM
MLA Citation
Stein, Mark N., et al. “A phase I study of AT-101, a BH3 mimetic, in combination with paclitaxel and carboplatin in solid tumors.Invest New Drugs, vol. 38, no. 3, June 2020, pp. 855–65. Pubmed, doi:10.1007/s10637-019-00807-2.
URI
https://scholars.duke.edu/individual/pub1404313
PMID
31388792
Source
pubmed
Published In
Invest New Drugs
Volume
38
Published Date
Start Page
855
End Page
865
DOI
10.1007/s10637-019-00807-2

Practice gaps and challenges integrating new immuno-oncology agents in the treatment of cancer patients in the United States: A mixed-method study.

Authors
Ready, NE; Parikh, AR; Lazure, P; Peniuta, M; Davies, M; Augustyniak, M; Caterino, J; Lewandowski, R; Lazar, AJ; Murray, S
URI
https://scholars.duke.edu/individual/pub1467357
Source
wos-lite
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
38
Published Date