Thoracic

Oncology

Translational

Research At UCLA and TRIO-US

Inside this issue

KEYNOTE-189 Trial Results…….......1

Publication in NEJM

New Mesothelioma Trial Opens…...1

PrECOG PrE0505

SCLC Trial Completing Patient Accru-al Soon………..…………………………...…..1

AZ CASPIAN

TOTR at ASCO..……………………………..2

A list of research abstracts to be presented by our team at the 2018 Annual Meeting of the American Society of Clinical Oncology

Contact Information……………………..2

Issue 61 April 2018

1

Dr. Aaron Lisberg’s PrECOG PrE0505 trial for malignant pleural mesothelioma is now open to enrollment at

UCLA Main Campus. PrE0505 is a phase 2, single-arm study of the immunotherapy drug durvalumab in combi-

nation with chemotherapy for unresectable malignant pleural mesothelioma. In order to be eligible, patients

must not have received any prior systemic therapy for their cancer, including certain immunotherapies. Pa-

tients who are enrolled in the study will receive durvalumab with pemetrexed/cisplatin chemotherapy every

three weeks for up to six treatment cycles, after which those whose cancer is stable or is responding to treat-

ment may go on to receive treatment with durvalumab alone every three weeks for up to 12 months from the

initiation of combination therapy.

Those who are interested should contact Dr. Aaron Lisberg for more information.

New Trial for First-Line Malignant Pleural Mesothelioma Now Open

Results from KEYNOTE-189 Clinical Trial Published in the New England Journal of Medicine Our program’s Dr. Edward Garon is among the authors of an article published this month in the New England

Journal of Medicine, which describes the results of the KEYNOTE-189 clinical trial. KEYNOTE-189 was a phase 3

study of the drug pemetrexed plus platinum-based chemotherapy in combination with either the immunotherapy

drug pembrolizumab or placebo in previously untreated, advanced NSCLC patients lacking EGFR and ALK muta-

tions. A total of 616 patients were randomized to receive pemetrexed and platinum-based chemotherapy plus

either pembrolizumab or placebo. The authors found that the estimated rate of overall survival at 12 months was

higher in the pembrolizumab combination group with 69.2% of patients still living, compared to 49.4% in the

placebo combination group. Median survival without disease progression was also higher in the pembrolizumab

combination group at 8.8 months, compared to 4.9 months in the placebo combination group. The authors fur-

thermore found that the addition of pembrolizumab to pemetrexed-platinum chemotherapy did not increase the

frequency of adverse events—meaning negative medical events experienced while on the trial—in patients when

compared to chemotherapy alone, nor did it increase the frequency of immune system-related adverse events

when compared to pembrolizumab therapy alone. Only the risk of nephritis and acute kidney injury, which are

negative effects associated with pemetrexed and platinum-based drugs, appeared to be higher in comparison to

earlier trials of therapy with pembrolizumab alone. In sum, the authors found that in previously untreated pa-

tients, the addition of pembrolizumab to pemetrexed and a platinum chemotherapy followed by pembrolizumab

with pemetrexed maintenance therapy resulted in notably longer overall and progression-free survival, as well as

a higher response rate, with relatively moderate increases in negative drug effects when compared to placebo.

Dr. Jonathan Goldman’s AZ CASPIAN trial is expected to complete enrollment of new patients in the next 1-2

months, after which the study will be closed to new patient accrual. For those who are interested, AZ CASPI-

AN is a study for extensive-stage small cell lung cancer patients who have received no prior systemic treat-

ment. Patients who are enrolled will receive the immunotherapy drug durvalumab in combination with chem-

otherapy. Some patients will be randomized to receive another immunotherapy drug called tremelimumab in

addition to durvalumab and chemotherapy. The study is currently open to enrollment at UCLA Main Campus,

and at TRIO-US sites in Ft. Wayne, IN; Grand Junction, CO; Paducah, KY; Orlando, FL; and Wichita, KS.

Those who are interested should contact Dr. Jonathan Goldman for more information.

AZ CASPIAN Trial Expected to Complete Accrual of Patients In the Near Future

Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Vigueira B, Novello S, Kurata T, Gray JE, Vida J, Raftopoulos H, Pietanza MC, Garassino MC, KEYNOTE-189 Investigators. N Engl J Med. 2018, Apr 16. doi: 10.1056/NEJMoa1801005 [Epub ahead of print]

2

Team Members

FACULTY Edward Garon, M.D. Program Director (310) 586-2098

Jonathan Goldman, M.D. Director of Clinical Trials (310) 829-5471

Siwen Hu-Lieskovan, M.D., Ph.D. (310) 794-4955

Aaron Lisberg, M.D. (310) 829-5471

Olga Olevsky, M.D. (310) 794-4955

Saeed Sadeghi, M.D. (310) 829-5471

Deborah Wong, M.D., Ph.D. (310) 586-2098

Patricia Young, M.D. (310) 325-8252

STUDY COORDINATORS Carlos Adame (310) 453-2184

Courtney Wells (310) 633-8400 ext. 20113

Lauren Sauer (310) 633-8400

Rachel Andes (310) 582-4062

Tawny Williams (310) 633-8400 ext. 01470

LABORATORY SCIENTISTS Naeimeh Kamranpour (310) 586-2083

Dongmei Hou (310) 586-2083

REGULATORY COORDINATORS Leo Rostamian (310) 794-6500

Lia Etheridge (310) 825-7174

Sandra Hernandez (310) 825-2621

PROGRAM COORDINATORS Benjamin Jones (Clinical) (310) 453-2183

James Carroll (Correlative) (310) 453-2183

NURSE PRACTITIONERS Melody Mendenhall (310) 829-5471

Blanca Ledezma (310) 829-5471

UCLA Hematology & Oncology

2020 Santa Monica Blvd, Suite 600

Santa Monica, CA 90404

Phone: (310) 829-5471 | Fax: (310) 582-6349

Contact Us

TOTR At the American Society of Clinical Oncology Annual Meeting 2018

Felip E, Hellmann MD, Hui R, Carcereny E, Leighl NB,

Ahn M-J, Eder JP, Balmanoukian AS, Aggarwal C, Horn

L, Patnaik A, Gubens M, Ramalingam SS, Lubiniecki GM,

Jensen E, Kush D, Garon EB. Four-year overall survival

for patients with advanced NSCLC treated with pem-

brolizumab: results from KEYNOTE-001. ASCO Annual

Meeting. 2018, June 1-5. Chicago, IL. Abstract nr. 9030.

Garassino M, Rodriguez-Abreu D, Gadgeel S, Esteban E,

Felip E, De Angelis F, Domine M, Hochmair MJ, Powell

S, Cheng S Y-S, Bischoff HG, Peled N, Reck M, Hui R,

Garon EB, Boyer M, Yang J, Burke T, Pietanza MC,

Gandhi L. Health-related quality of life (HRQoL) in the

KEYNOTE-189 study of pembrolizumab (pembro) or

placebo (pbo) + pemetrexed (pem) + platinum (plt) for

metastatic NSCLC. ASCO Annual Meeting. 2018, June 1-

5. Chicago, IL. Abstract nr. 9021.

Garon E, Spira A, Goldberg S, Chaft J, Papadimi-

trakopoulou V, Antonia S, Brahmer J, Camidge R,

Powderly J, Wozniak A, Felip E, Gao G, Englert J, Awad

M. Safety and activity of durvalumab + tremelimumab

in immunotherapy (IMT)-pretreated advanced NSCLC

patients. ASCO Annual Meeting. 2018, June 1-5. Chica-

go, IL. Abstract nr. 9041.

Garon E, Wong DJ, Schneider JG, Aljumaily R, Korn WM,

Infante JR, Patel M, Autio KA, Papadopoulos KP, Naing

A, Gabrail NY, Munster PN, Goldman J, Hung A, Van

Vlasselaer P, Leveque J, Oft M, Spigel D. Responses and

durability in NSCLC treated with pegilodecakin and anti

-PD-1. ASCO Annual Meeting. 2018, June 1-5. Chicago,

IL. Abstract nr. 9018

Goldman JW, et al. A randomized phase 3 study of

abemaciclib versus erlotinib in previously treated

patients with stage IV NSCLC with KRAS mutation:

JUNIPER. ASCO Annual Meeting. 2018, June 1-5. Chica-

go, IL. Abstract nr. 9025.

Goldman JW, et al. Safety and antitumor activity of

durvalumab monotherapy in patients with pretreated

extensive disease small-cell lung cancer (ED-SCLC).

ASCO Annual Meeting. 2018, June 1-5. Chicago, IL.

Abstract nr. 8518.

Lisberg AE, Cummings AL, Goldman JW, Bornazyan K,

Reese ND, Wang T, Coluzzi P, Ledezma BA, Mendenhall

MA, Jones B, Madrigal J, Carroll JM, Gukasyan J, Wil-

liams T, Sauer L, Wells CL, Hardi AR, Linares PJ, Adame

CR, Garon EB. A phase II study of pembrolizumab in

EGFR-mutant, PD-L1+, tyrosine kinase inhibitor (TKI)

naïve patients with advanced NSCLC. ASCO Annual

Meeting. 2018, June 1-5. Chicago, IL. Abstract nr. 9014.

Lu H, Cummings A, Goldman JW, Lisberg A, Hu-

Lieskovan S, Grogan T, Gukasyan J, Madrigal J, Carroll J,

Bornazyan K, Jones B, Noor Z, Zaretsky J, Elashoff D,

Slamon D, Dubinett S, Garon E. Human leukocyte

antigen (HLA) B44 supertype and immunotherapy

outcomes in non-small cell lung cancer (NSCLC). ASCO

Annual Meeting. 2018, June 1-5. Chicago, IL. Abstract

nr. 3026.

Sands JM, Shimizu T, Garon EB, Greenberg J, Heist RS,

Kobayashi FK, Noguchi Y, Okajima D, Spira A, Yamamo-

to N, Yamashita T, Lisberg AE. First-in-human phase 1

study of DS-1062a in patients (pts) with advanced solid

tumors (AST). ASCO Annual Meeting. 2018, June 1-5.

Chicago, IL. Abstract nr. TPS2605.

Rusch V, Chaft J, Johnson B, Wistuba I, Kris MG, Lee JM,

Bunn P, Kwiatkowski DJ, Reckamp K, Finley D, Haura E,

Waqar S, Doebele R, Garon E, Blasberg J, Nicholas A,

Schulze K, Phan S, Gandhi M, Carbone D. Neoadjuvant

atezolizumab in resectable non-small cell lung cancer

(NSCLC): initial results from a multicenter study (LCMC

3). ASCO Annual Meeting. 2018, June 1-5. Chicago, IL.

Abstract nr. 8541.

Congratulations to all TOTR program members presenting at the 2018 ASCO Annual meeting: