8-K - GILD - Equibles

UNITED STATES

SECURITIES AND EXCHANGECOMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuantto Section 13 or 15(d) of The Securities Exchange Act of 1934

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): August 16, 2023

GILEAD SCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware	0-19731	94-3047598
(State or Other Jurisdiction of<br><br><br> Incorporation)	(Commission File No.)	(IRS Employer<br><br>Identification No.)

333Lakeside Drive**, Foster City** , California

(Address of Principal Executive Offices)

94404

(Zip Code)

650-574-3000

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class:	Trading Symbol(s)	Name<br> of Each Exchange on Which Registered
Common Stock, par value, $0.001 per share	GILD	The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01	Regulation FD Disclosure.

On August 16, 2023, Gilead Sciences, Inc., a Delaware corporation (the “Company”), announced that the International Association for the Study of Lung Cancer (“IASLC”) inadvertently posted the following presentation on the IASLC’s 2023 World Conference on Lung Cancer website on the morning of August 16, 2023:

-	“Sacituzumab Govitecan + Pembrolizumab in 1L Metastatic Non-Small Cell Lung Cancer: Preliminary Results of the EVOKE-02 Study”

Such posting by IASLC, ahead of the Company’s planned disclosure in connection with the conference, was not authorized by the Company. The presentation is attached as Exhibit 99.1 hereto and incorporated herein by reference.

The information in Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01	Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Presentation<br> titled “Sacituzumab Govitecan + Pembrolizumab in 1L Metastatic Non-Small Cell Lung Cancer: Preliminary Results of the EVOKE-02<br> Study”
104	Cover<br> Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

GILEAD SCIENCES, INC.
(Registrant)
/s/ DEBORAH H. TELMAN
Deborah H. Telman
EVP, Corporate Affairs, General Counsel and Corporate Secretary
Date:	August 16, 2023
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Exhibit 99.1

Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>1<br>DRAFT<br>Sacituzumab Govitecan + Pembrolizumab in<br>1L Metastatic Non-Small Cell Lung Cancer:<br>Preliminary Results of the EVOKE-02 Study<br>Byoung Chul Cho,1 Manuel Cobo Dols,2 Roxana Reyes Cabanillas,3 David Vicente,4 Jose Fuentes Pradera,5<br>Salvatore Grisanti,6 Afshin Eli Gabayan,7 Ki Hyeong Lee,8 Eun Kyung Cho,9 Sabeen Mekan,10 Farnoush Safavi,10<br>Nelumka Fernando,10 Michael J. Chisamore,11 Martin Reck12<br>1Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea; 2Regional and Virgen de la<br>Victoria University Hospitals, IBIMA, Malaga, Spain; 3Hospital Clinic de Barcelona, Barcelona, Spain; 4Hospital Universitario Virgen Macarena,<br>Seville, Spain; 5Hospital Universitario Virgen de Valme, Seville, Spain; 6Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy; 7Beverly Hills<br>Cancer Center, Beverly Hills, CA, USA; 8Chungbuk National University Hospital, Chungbuk, Republic of Korea; 9Gachon University Gil Medical<br>Center, Incheon, Republic of Korea; 10Gilead Sciences, Inc., Foster City, CA, USA; 11Merck & Co., Inc., Rahway, NJ, USA; 12Airway Research<br>Center North, German Center for Lung Research (DZL), LungenClinic, Grosshansdorf, Germany<br>Draft as of August 16, 2023
Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>2<br>DRAFT<br>Introduction<br> • PD-(L)1 inhibitor-based regimens have been established as the standard-of-care 1L treatment for<br>mNSCLC,1,2 and novel combination therapies are needed to further improve outcomes<br> • Sacituzumab govitecan is a Trop-2–directed ADC approved in the United States for the treatment of<br>2L+ mTNBC and pretreated HR+/HER2– mBC, and received accelerated approval for 2L mUC3<br> • Sacituzumab govitecan has previously demonstrated clinical activity and manageable safety in heavily<br>pretreated patients with mNSCLC4<br> • EVOKE-02 (NCT05186974) is an ongoing, multicohort phase 2 study of sacituzumab govitecan +<br>pembrolizumab ± platinum agent in patients with untreated 1L mNSCLC<br> • Here, we report preliminary results of patients treated with sacituzumab govitecan + pembrolizumab in<br>Cohorts A and B from the EVOKE-02 study<br>1L, first-line; 2L, second-line; 2L+, second-line and beyond; ADC, antibody-drug conjugate; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormonal receptor-positive; mBC, metastatic<br>breast cancer; mNSCLC, metastatic non-small cell lung cancer; mTNBC, metastatic triple-negative breast cancer; mUC, metastatic urothelial cancer; PD-(L)1, programmed death (ligand) 1.<br>1. Hendriks LE, et al. Ann Oncol. 2023;34:358-376. 2. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer<br>Network, Inc. 2023. All rights reserved. Accessed June 15, 2023. 3. TRODELVY® (sacituzumab govitecan-hziy) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; February 2023.<br>4. Heist RS, et al. J Clin Oncol. 2017;35:2790-2797.
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>3<br>DRAFT aDose de-escalation safety run-in period to determine the RP2D of SG for Cohorts C and D. bCarboplatin dosed as area under the concentration versus time curve 5. cPer RECIST v1.1.<br>ECOG PS, Eastern Cooperative Oncology Group performance status; D, day; DLT, dose-limiting toxicity; DCR, disease control rate; DOR, duration of response; IV, intravenous; NSCLC, non-small<br>cell lung cancer; Nsq, nonsquamous; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PD, progressive disease; Pembro, pembrolizumab; PFS, progression-free survival; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; RP2D, recommended phase 2 dose; SG, sacituzumab govitecan; Sq, squamous; TPS, tumor proportion score.<br>EVOKE-02: An Open-Label, Multicohort Phase 2 Study<br> • At data cutoff (16 June 2023), median (range) follow-up for Cohorts A and B was 5.0 (1.7-12.0) and 5.8 (1.0-12.2) months, respectively<br> • The preliminary efficacy data reported in this presentation are results by investigator assessment<br>Key eligibility criteria<br> • Stage IV NSCLC<br> • Measurable disease per<br>RECIST v1.1<br> • No known actionable genomic<br>alterations<br> • ECOG PS 0-1<br> • No prior systemic treatment for<br>metastatic NSCLC<br>N ≈ 176-224<br>Cohort A<br>PD-L1 TPS ≥ 50%<br>Nsq or Sq<br>n ≈ 30<br>Cohort B<br>PD-L1 TPS < 50%<br>Nsq or Sq<br>n ≈ 60<br>Cohort C<br>Any PD-L1 TPS<br>Nsq only<br>n ≈ 40<br>Cohort D<br>Any PD-L1 TPS<br>Sq only<br>n ≈ 40<br>Carboplatin<br>Safety Run-ina<br>Any PD-L1 TPS<br>Nsq or Sq<br>n ≈ 6-18<br>21-day cycles:<br>SG 10 mg/kg IV on D1 and D8<br>(until PD or unacceptable toxicity) +<br>Pembro 200 mg IV on D1<br>(up to 35 cycles)<br>21-day cycles:<br>SG RP2D IV on D1 and D8<br>(until PD or unacceptable toxicity) +<br>Pembro 200 mg IV on D1<br>(up to 35 cycles) +<br>Carboplatinb IV on D1<br>(up to 4 cycles)<br>End points<br>Primary<br> • ORRc<br> • DLTs in safety<br>run-in<br>Secondary<br> • DCR, DOR, and<br>PFSc<br> • OS<br> • Safety
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>4<br>DRAFT aDisease stage at diagnosis: Stage I-III (Cohort A, n = 5; Cohort B, n = 5). bThe PD-L1 IHC 22C3 pharmDx assay was required for PD-L1 testing. Local and central tumor tissue testing were allowed.<br>ECOG PS, Eastern Cooperative Oncology Group performance status; PD-L1, programmed death ligand 1; Pembro, pembrolizumab; SG, sacituzumab govitecan; TPS, tumor proportion score.<br>Patient Baseline Characteristics, Exposure, and Disposition<br>Characteristic<br>Cohort A<br>(PD-L1 TPS ≥ 50%)<br>SG + Pembro<br>n = 30<br>Cohort B<br>(PD-L1 TPS < 50%)<br>SG + Pembro<br>n = 33<br>Median age (range), years 67 (47-77) 68 (47-80)<br>Male, % 80 79<br>Race, %<br>Asian 20 15<br>Black 7 3<br>White 73 82<br>ECOG PS 1, % 80 76<br>Histology, %<br>Nonsquamous 60 61<br>Squamous 40 39<br>Stage IV disease at diagnosis,a % 80 85<br>PD-L1 TPS,b %<br> ≥ 50% 100 0<br>1-49% 0 48<br> < 1% 0 52<br>Patient exposure and disposition<br>Cohort A<br>(PD-L1 TPS ≥ 50%)<br>SG + Pembro<br>n = 30<br>Cohort B<br>(PD-L1 TPS < 50%)<br>SG + Pembro<br>n = 33<br>Median duration of treatment (range), months<br>SG 4.1 (0-11.2+) 4.1 (0-11.9+)<br>Pembro 3.6 (0-11.2+) 3.8 (0-11.7+)<br>Median number of cycles received (range), cycles<br>SG 6 (1-17+) 6 (1-17+)<br>Pembro 6 (1-17+) 6 (1-17+)<br>Continuing treatment with SG, % 63 39<br>Continuing treatment with Pembro, % 63 42<br>Discontinued all study treatment, % 37 58<br> • Across both cohorts, the most common reason for discontinuation<br>of sacituzumab govitecan was progressive disease
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>5<br>DRAFT<br>Only patients enrolled ≥ 13 weeks prior to the data cutoff date (16 June 2023) were included in the efficacy analysis. aPatients without tumor assessment (Cohort A, n = 1; Cohort B, n = 5). bORR was<br>defined as BOR of CR + PR. c<br>DCR was defined as BOR of CR + PR + SD ≥ 6 weeks. dEvaluated in patients with a confirmed complete or partial response. eBased on Kaplan-Meier estimates.<br>BOR, best overall response; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; INV, investigator assessment; NR, not reached; ORR, objective<br>response rate; PD, progressive disease; PD-L1, programmed death ligand 1; Pembro, pembrolizumab; PR, partial response; SD, stable disease; SG, sacituzumab govitecan; TPS, tumor proportion score.<br>Efficacy by Investigator Assessment<br>Efficacy by INVa<br>Cohort A (PD-L1 TPS ≥ 50%)<br>SG + Pembro<br>n = 29<br>Cohort B (PD-L1 TPS < 50%)<br>SG + Pembro<br>n = 32<br>Total<br>SG + Pembro<br>n = 61<br>ORR,b n (%) 20 (69) 14 (44) 34 (56)<br>PR, n (%) – confirmed and unconfirmed 20 (69) 14 (44) 34 (56)<br>Confirmed PR, n (%) 18 (62) 12 (38) 30 (49)<br>SD, n (%) 5 (17) 11 (34) 16 (26)<br>PD, n (%) 3 (10) 2 (6) 5 (8)<br>DCRc (95% CI), % 86 (68-96) 78 (60-91) 82 (70-91)<br>Median DORd,e (95% CI), months NR (5.6-NR) NR (3.5-NR) NR (7.9-NR)<br>DOR rate at 6 monthsd,e (95% CI), % 88 (39-98) 88 (39-98) 87 (58-97)<br>ORRb (95% CI), % 69 (49-85) 44 (26-62) 56 (42-69)
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>6<br>DRAFT<br>Only patients enrolled ≥ 13 weeks prior to the data cutoff date (16 June 2023) were included in the efficacy analysis. PD-L1, programmed death ligand 1; TPS, tumor proportion score.<br>Waterfall Plot for Change in Target Lesions<br>Total<br>Best overall response<br>Partial response (n = 30)<br>Stable disease (n = 20)<br>Progressive disease (n = 4)<br>Cohort A (PD-L1 TPS ≥ 50%)<br>Cohort B (PD-L1 TPS < 50%)<br>100<br>80<br>60<br>40<br>20<br>0<br>-20<br>-40<br>-60<br>-80<br>-100 Best percent change from baseline<br>Participant
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>7<br>DRAFT<br>Only patients enrolled ≥ 13 weeks prior to the data cutoff date (16 June 2023) were included in the efficacy analysis. PD-L1, programmed death ligand 1; Pembro, pembrolizumab; SG, sacituzumab<br>govitecan; TPS, tumor proportion score.<br>Depth and Duration of Response<br>Cohort A (PD-L1 TPS ≥ 50%)<br>SG + Pembro<br>Cohort B (PD-L1 TPS < 50%)<br>SG + Pembro 100<br>Percent change from baseline<br> – target lesions<br>Weeks<br>90<br>80<br>70<br>60<br>50<br>40<br>30<br>20<br>10<br>0<br>-10<br>-20<br>-30<br>-40<br>-50<br>-60<br>-70<br>-80<br>-90<br>-100<br>0 6 12 18 24 30 36 42 48 54<br>Best overall response<br>Partial response (n = 18)<br>Stable disease (n = 7)<br>Progressive disease (n = 3)<br>Last assessment before data cutoff<br>100<br>Percent change from baseline<br> – target lesions<br>Weeks<br>90<br>80<br>70<br>60<br>50<br>40<br>30<br>20<br>10<br>0<br>-10<br>-20<br>-30<br>-40<br>-50<br>-60<br>-70<br>-80<br>-90<br>-100<br>0 6 12 18 24 30 36 42 48 54<br>Best overall response<br>Partial response (n = 12)<br>Stable disease (n = 13)<br>Progressive disease (n = 1)<br>Last assessment before data cutoff
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>8<br>DRAFT<br>All patients who received ≥ 1 dose of study treatment were included in the safety analysis. Pembro, pembrolizumab; SG, sacituzumab govitecan; TEAE, treatment-emergent adverse event.<br>Safety Summary<br>Safety-evaluable patients, n (%)<br>Total<br>SG + Pembro<br>n = 63<br>Any-grade TEAEs 63 (100)<br>Related to study treatment 57 (90)<br>Grade ≥ 3 TEAEs 44 (70)<br>Related to study treatment 24 (38)<br>Serious TEAEs 34 (54)<br>Related to study treatment 9 (14)<br>TEAEs leading to treatment discontinuation 11 (18)<br>TEAEs leading to discontinuation of SG 9 (14)<br>TEAEs leading to discontinuation of Pembro 8 (13)<br>TEAEs leading to SG dose reductions 11 (18)<br>TEAEs leading to deatha 4 (6)<br>Related to study treatment 1 (2)<br>aTEAEs leading to death included: malignant lung neoplasm (n = 1), respiratory tract infection (n = 1), sepsis (n = 1), and sudden death (n = 1). The 1 case of sepsis<br>leading to death was deemed related to study treatment.
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>9<br>DRAFT<br>All patients who received ≥ 1 dose of study treatment were included in the safety analysis. aGrade 3 pneumonitis was the highest grade observed to date (n = 2). Pembro, pembrolizumab;<br>TEAE, treatment-emergent adverse event.<br> • Immune-mediated TEAEs were consistent with the known<br>safety profile of Pembro<br>5 5 2 2<br>3<br>2<br>2 2 0<br>10<br>20<br>30<br>40<br>50<br>60<br>Pneumonitis<br>Hyperthyroidism<br>Colitis<br>Nephritis<br>Maculopapular rash<br>Hypothyroidism<br>Percent of patients (%)<br>Immune-mediated TEAEs<br>Grade 1-2 Grade ≥ 3<br>a<br>51<br>42<br>38 37<br>30<br>9<br>20<br>24 22<br>17 19 18<br>3<br>6<br>2<br>18<br>5<br>5 2<br>0<br>10<br>20<br>30<br>40<br>50<br>60<br>Diarrhea<br>Anemia<br>Asthenia<br>Alopecia<br>Nausea<br>Neutropenia<br>Respiratory tract infection<br>Constipation<br>Decreased appetite<br>Dyspnea<br>Fatigue<br>Mucosal inflammation<br>Percent of patients (%)<br>Any-grade TEAEs reported in<br> ≥ 15% of patients<br>Grade 1-2 Grade ≥ 3<br> • The most common any-grade TEAEs were diarrhea (54%),<br>anemia (48%), and asthenia (38%)
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>10<br>DRAFT<br>1L, first-line; DCR, disease control rate; DOR, duration of response; mNSCLC, metastatic non-small cell lung cancer; ORR, objective response rate; PD-L1, programmed death ligand 1;<br>Pembro, pembrolizumab; SG, sacituzumab govitecan; TEAE, treatment-emergent adverse event; TPS, tumor proportion score.<br>Conclusions<br> • SG + Pembro demonstrated encouraging antitumor activity in patients with 1L mNSCLC across PD-L1 subgroups<br> ‒ ORR was 69% and DCR was 86% in Cohort A<br> ‒ ORR was 44% and DCR was 78% in Cohort B<br> ‒ Median DOR was not reached, and DOR rate at 6 months was 88% in both cohorts<br> • The safety profile of SG + Pembro was manageable and consistent with the known safety of each agent<br> ‒ The most common any-grade TEAEs were diarrhea, anemia, and asthenia<br> ‒ TEAEs leading to treatment discontinuation were low (18%)<br> • These preliminary results warrant further investigation of SG + Pembro for the 1L treatment of mNSCLC<br> ‒ The ongoing, open-label, global, randomized, phase 3 EVOKE-03 study (NCT05609968) is evaluating SG + Pembro<br>versus Pembro monotherapy in patients with untreated 1L mNSCLC with PD-L1 TPS ≥ 50%
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Byoung Chul Cho, Yonsei Cancer Center, Republic of Korea<br>11<br>DRAFT<br>Acknowledgments<br> • We would like to thank the patients, their caregivers, and families for their participation and commitment<br>to clinical research<br> • Thank you to the clinical trial investigators and their team members, without whom this work would not<br>have been possible<br> • This study was sponsored by Gilead Sciences, Inc.<br> • This study is in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,<br>Rahway, NJ, USA<br> • Medical writing and editorial support was provided by Andrew Scott, PharmD, of Parexel and funded by<br>Gilead Sciences, Inc.
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