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:

What's next for immunotherapy in locally advanced NSCLC?

Authors
MLA Citation
Ready, Neal Edward. “What's next for immunotherapy in locally advanced NSCLC?Clin Adv Hematol Oncol, vol. 19, no. 5, May 2021, pp. 302–04.
URI
https://scholars.duke.edu/individual/pub1482179
PMID
33989277
Source
pubmed
Published In
Clinical Advances in Hematology & Oncology : H&O
Volume
19
Published Date
Start Page
302
End Page
304

Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer.

OBJECTIVES: Pembrolizumab is a programmed death receptor-1 masking antibody approved for metastatic non-small cell lung cancer. This Phase 2 study (NCT02818920) of neoadjuvant pembrolizumab in non-small cell lung cancer had a primary end point of safety and secondary end points of efficacy and correlative science. METHODS: Patients with untreated clinical stage IB to IIIA non-small cell lung cancer were enrolled. Two cycles of pembrolizumab (200 mg) were administered before surgery. Standard adjuvant chemotherapy and radiation were encouraged but not required. Four cycles of adjuvant pembrolizumab were provided. RESULTS: Of 35 patients enrolled, 30 received neoadjuvant pembrolizumab and 25 underwent lung resection. Only 1 patient had a delay before surgery attributed to pembrolizumab; this was due to thyroiditis. All patients underwent anatomic resection and mediastinal lymph node dissection; the majority (18/25%, 72%) of patients underwent lobectomy. Of the 25 patients, 23 had an initial minimally invasive approach (92%); 5 of these were converted to thoracotomy (21.7%). R0 resection was achieved in 22 patients (88%), and major pathologic response was observed in 7 of 25 patients (28%). The most common postoperative adverse event was atrial fibrillation, affecting 6 of 25 patients (24%). Median chest tube duration and length of stay were 3 and 4 days, respectively. One patient required readmission to the hospital within 30 days. There was no mortality within 90 days of surgery. CONCLUSIONS: In this study, pembrolizumab was safe and well tolerated in the neoadjuvant setting, and its use was not associated with excess surgical morbidity or mortality. Minimally invasive approaches are feasible in this patient population, but may be more challenging than in cases without neoadjuvant immunotherapy. Pathologic response was higher than typically observed with standard neoadjuvant chemotherapy.
Authors
Tong, BC; Gu, L; Wang, X; Wigle, DA; Phillips, JD; Harpole, DH; Klapper, JA; Sporn, T; Ready, NE; D'Amico, TA
MLA Citation
Tong, Betty C., et al. “Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer.J Thorac Cardiovasc Surg, Apr. 2021. Pubmed, doi:10.1016/j.jtcvs.2021.02.099.
URI
https://scholars.duke.edu/individual/pub1482178
PMID
33985811
Source
pubmed
Published In
The Journal of Thoracic and Cardiovascular Surgery
Published Date
DOI
10.1016/j.jtcvs.2021.02.099

Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.

<h4>Purpose</h4>In extensive-disease small-cell lung cancer (ED-SCLC), response rates to first-line platinum-based chemotherapy are robust, but responses lack durability. CheckMate 451, a double-blind phase III trial, evaluated nivolumab plus ipilimumab and nivolumab monotherapy as maintenance therapy following first-line chemotherapy for ED-SCLC.<h4>Methods</h4>Patients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy were randomly assigned (1:1:1) to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks for 12 weeks followed by nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo for ≤ 2 years or until progression or unacceptable toxicity. Primary end point was overall survival (OS) with nivolumab plus ipilimumab versus placebo. Secondary end points were hierarchically tested.<h4>Results</h4>Overall, 834 patients were randomly assigned. The minimum follow-up was 8.9 months. OS was not significantly prolonged with nivolumab plus ipilimumab versus placebo (hazard ratio [HR], 0.92; 95% CI, 0.75 to 1.12; <i>P</i> = .37; median, 9.2 <i>v</i> 9.6 months). The HR for OS with nivolumab versus placebo was 0.84 (95% CI, 0.69 to 1.02); the median OS for nivolumab was 10.4 months. Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81). A trend toward OS benefit with nivolumab plus ipilimumab was observed in patients with tumor mutational burden ≥ 13 mutations per megabase. Rates of grade 3-4 treatment-related adverse events were nivolumab plus ipilimumab (52.2%), nivolumab (11.5%), and placebo (8.4%).<h4>Conclusion</h4>Maintenance therapy with nivolumab plus ipilimumab did not prolong OS for patients with ED-SCLC who did not progress on first-line chemotherapy. There were no new safety signals.
Authors
Owonikoko, TK; Park, K; Govindan, R; Ready, N; Reck, M; Peters, S; Dakhil, SR; Navarro, A; Rodríguez-Cid, J; Schenker, M; Lee, J-S; Gutierrez, V; Percent, I; Morgensztern, D; Barrios, CH; Greillier, L; Baka, S; Patel, M; Lin, WH; Selvaggi, G; Baudelet, C; Baden, J; Pandya, D; Doshi, P; Kim, HR
MLA Citation
Owonikoko, Taofeek K., et al. “Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 39, no. 12, Apr. 2021, pp. 1349–59. Epmc, doi:10.1200/jco.20.02212.
URI
https://scholars.duke.edu/individual/pub1475992
PMID
33683919
Source
epmc
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
39
Published Date
Start Page
1349
End Page
1359
DOI
10.1200/jco.20.02212

Predictive Value of Combining Biomarkers for Clinical Outcomes in Advanced Non-Small Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors.

INTRODUCTION: A high tumor mutational burden (TMB) (≥10 mut/Mb) has been associated with improved clinical benefit in non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICI) and is a tumor agnostic indication for pembrolizumab across tumor types. We explored whether combining TMB with programmed cell death ligand 1 (PD-L1) and pretreatment neutrophil-lymphocyte ratio (NLR) was associated with improved outcomes in ICI-treated NSCLC. METHODS: We retrospectively analyzed patients treated with ICI with Foundation One genomic testing, including TMB. Optimal cutoff for prediction of response by TMB was determined by receiver operating characteristic analysis, and area under the curve (AUC) was calculated for all 3 biomarkers and combinations. Cox model was used to assess prognostic factors of overall survival (OS) and time to progression (TTP). Survival cutoffs calculated with Kaplan-Meier survival curves were TMB ≥10 mut/Mb, PD-L1 ≥50%, NLR <5, and combined biomarkers. RESULTS: Data from 88 patients treated were analyzed. The optimal TMB cutoff was 9.24 mut/Mb (AUC, 0.62), improving to 0.74 combining all 3 biomarkers. Adjusted Cox model showed that TMB ≥10 mut/Mb was an independent factor of OS (hazard ratio [HR], 0.31; 95% confidence interval; 0.14-0.69; P = .004) and TTP (HR, 0.46; 95% CI, 0.27-0.77; P = .003). The combination of high TMB with positive PD-L1 and low NLR was significantly associated with OS (P = .038) but not TTP. CONCLUSIONS: TMB has modest predictive and prognostic power for clinical outcomes after ICI treatment. The combination of TMB, PD-L1, and NLR status improves this power.
Authors
Kao, C; Powers, E; Wu, Y; Datto, MB; Green, MF; Strickler, JH; Ready, NE; Zhang, T; Clarke, JM
MLA Citation
URI
https://scholars.duke.edu/individual/pub1481799
PMID
33972172
Source
pubmed
Published In
Clin Lung Cancer
Published Date
DOI
10.1016/j.cllc.2021.03.017

New Approaches to SCLC Therapy: From the Laboratory to the Clinic.

The outcomes of patients with SCLC have not yet been substantially impacted by the revolution in precision oncology, primarily owing to a paucity of genetic alterations in actionable driver oncogenes. Nevertheless, systemic therapies that include immunotherapy are beginning to show promise in the clinic. Although, these results are encouraging, many patients do not respond to, or rapidly recur after, current regimens, necessitating alternative or complementary therapeutic strategies. In this review, we discuss ongoing investigations into the pathobiology of this recalcitrant cancer and the therapeutic vulnerabilities that are exposed by the disease state. Included within this discussion, is a snapshot of the current biomarker and clinical trial landscapes for SCLC. Finally, we identify key knowledge gaps that should be addressed to advance the field in pursuit of reduced SCLC mortality. This review largely summarizes work presented at the Third Biennial International Association for the Study of Lung Cancer SCLC Meeting.
Authors
Poirier, JT; George, J; Owonikoko, TK; Berns, A; Brambilla, E; Byers, LA; Carbone, D; Chen, HJ; Christensen, CL; Dive, C; Farago, AF; Govindan, R; Hann, C; Hellmann, MD; Horn, L; Johnson, JE; Ju, YS; Kang, S; Krasnow, M; Lee, J; Lee, S-H; Lehman, J; Lok, B; Lovly, C; MacPherson, D; McFadden, D; Minna, J; Oser, M; Park, K; Park, K-S; Pommier, Y; Quaranta, V; Ready, N; Sage, J; Scagliotti, G; Sos, ML; Sutherland, KD; Travis, WD; Vakoc, CR; Wait, SJ; Wistuba, I; Wong, KK; Zhang, H; Daigneault, J; Wiens, J; Rudin, CM; Oliver, TG
MLA Citation
Poirier, John T., et al. “New Approaches to SCLC Therapy: From the Laboratory to the Clinic.J Thorac Oncol, vol. 15, no. 4, Apr. 2020, pp. 520–40. Pubmed, doi:10.1016/j.jtho.2020.01.016.
URI
https://scholars.duke.edu/individual/pub1432115
PMID
32018053
Source
pubmed
Published In
J Thorac Oncol
Volume
15
Published Date
Start Page
520
End Page
540
DOI
10.1016/j.jtho.2020.01.016