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Item 8.01. Other Events
On September 16, 2021, Leap Therapeutics, Inc. (the “Company”) issued a press release entitled “Leap Therapeutics Presents Updated Positive Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO Congress.”
As discussed in the press release, the Company presented its updated data in the form of a poster presentation at the European Society for Medical Oncology (ESMO) Conference.
The full text of the press release and a copy of the poster presentation are filed as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference; provided, however that information on or connected to our website referenced in the Company’s press release is expressly not incorporated by reference into or intended to be filed as a part of this Current Report on Form 8-K.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release dated September 16, 2021. | |
| 99.2 | ESMO Congress Poster Presentation | |
| 104 | Cover Page Interactive Data File. |
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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.
| LEAP THERAPEUTICS, INC. | ||
| Dated: September 16, 2021 | By: | /s/ Douglas E. Onsi |
| Name: | Douglas E. Onsi | |
| Title: | Chief Executive Officer and President | |
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Exhibit 99.1
Leap Therapeutics Presents Updated Positive Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO Congress
- DKN-01 plus tislelizumab and chemotherapy demonstrated compelling activity in first-line patients with gastric or gastroesophageal junction cancer
- Additional data presented today showed responses to treatment are independent of PD-L1 expression, with 79% ORR in patients with PD-L1 low (CPS < 5) tumors
- Company to host conference call on Friday, September 17, 2021 at 8:00 a.m. ET
Cambridge, MA – September 16, 2021 – Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced the presentation of updated positive data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) Congress. The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.
The Company announced positive initial data from the DisTinGuish study on Monday, September 13, 2021 based on 25 G/GEJ patients enrolled in the trial that showed DKN-01 in combination with tislelizumab and chemotherapy as first-line therapy was well tolerated with compelling activity. The results presented at the ESMO Congress today included additional patient data stratified by tumoral PD-L1 expression levels based on visually-estimated combined positive score (vCPS), showing that robust objective clinical responses can be achieved from this combination regimen independently of PD-L1 expression.
“Initial data from this trial have shown that patients with high levels of DKK1 expression, a group with a poor prognosis, had encouraging responses to treatment. The additional data presented today show evidence that not only is DKK1 a critical biomarker in predicting response to DKN-01 and tislelizumab therapy, but also that the combination can induce deep responses regardless of the patient’s PD-L1 status, including particularly poor prognosis patients with both low PD-L1 and high DKK1,” said Samuel Klempner, MD, Member of the Faculty at Massachusetts General Hospital Cancer Center and Harvard Medical School. “Taken together, these are promising results for the combination therapy of DKN-01 with tislelizumab and chemotherapy in first line patients with gastric or gastroesophageal junction cancers.”
About the DisTinGuish Study
The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.
Key Findings
| · | Among patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients |
| · | Response was independent of PD-L1 expression, and particularly strong in the less favorable to checkpoint inhibitor therapy, PD-L1 low (vCPS < 5), population |
| o | Among those patients with PD-L1-low expression (vCPS < 5), the ORR was 79%, with 100% in DKK1-high patients and 57% in DKK1-low patients |
| o | Among those patients with PD-L1-high expression (vCPS ≥ 5), the ORR was 67%, with 75% ORR in DKK1-high patients and 50% in DKK1-low patients |
| o | DKK1 levels could not be determined in one patient who had PD-L1 expression data; however, the patient’s PD-L1 expression level was determined to be low (vCPS score 0) and the patient achieved a partial response |
| · | DKK1 expression and PD-L1 expression are not correlated |
| · | Median duration of response and progression-free survival data are not yet mature, and patient follow-up continues |
Twenty-five first-line patients were enrolled, and as of the cut-off date of the presentation, 15 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), and three patients were unable to complete a full cycle of DKN-01 therapy (non-modified ITT (mITT)).
Among the 21 patients that had RNAscope® DKK1 expression available, 12 were DKK1-high [9 PR, 1 NE, 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD].
Among the 20 patients that had PD-L1 expression available, 14 were PD-L1 low vCPS < 5 [11 PR, 3 SD] and 6 were PD-L1 high vCPS > 5 [4 PR, 1 SD, 1 NE].
A copy of the poster presentation is available on the Company’s website at https://www.leaptx.com/our-pipeline.
Conference Call
Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr. Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company's website at https://investors.leaptx.com/, where a replay of the event will also be available for a limited time.
About Leap Therapeutics
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. For more information about Leap Therapeutics, visit http://www.leaptx.com or view our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.
RNAscope® is a registered trademark of Advanced Cell Diagnostics, Inc., Newark, CA, USA.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap's expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestone, or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics' periodic filings with the SEC, including Leap's Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on March 12, 2021 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports Leap files from time to time with the SEC. Any forward-looking statement contained in this release speaks only as of its date. Leap undertakes no obligation to update any forward-looking statement contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com
Exhibit 99.2
| DKN-01 in Combination with Tislelizumab and Chemotherapy as a First-line Therapy in Unselected Patients with Advanced Gastroesophageal Adenocarcinoma (GEA): DisTinGuish Trial Samuel J. Klempnera, Joseph Chaob, Vi K. Chiuc, Devalingam Mahalingamd, Hope Uronise, Cynthia A. Sirardf, Michael Kageyf, Jason Baumf, James Songg, Jin Wangg, Farshid Dayyanih, Syma Iqbali, Mohamedtaki Tejanij, Mohamad Sonbolk, Aaron J. Scottl, Zev Wainbergm, Jaffer Ajanin aMassachusetts General Hospital Cancer Center; Boston, MA; bCity of Hope Comprehensive Cancer Center, Duarte, CA; cThe Angeles Clinic and Research Institute, a Cedars-Sinai affiliate, Los Angeles, CA; dNorthwestern University, Chicago, IL; eDuke University Medical Center, Durham, NC; fLeap Therapeutics, Cambridge, MA; gBeiGene, Ltd, Beijing, China; hUniversity of California Irvine, Orange, CA; iUSC Norris Comprehensive Cancer Center, Los Angeles, CA; jAdventHealth Cancer Institute, Orlando, FL; kMayo Clinic Hospital, Phoenix, AZ; lUniversity of Arizona Cancer Center, Tuscon, AZ; mUniversity of California Los Angeles, Los Angeles, CA; nMD Anderson Cancer Center, Houston, TX Design: Phase 2a study of DKN-01 + tislelizumab + capecitabine/oxaliplatin (CAPOX) in advanced GEA patents Tumoral DKK1 mRNA expression: assessed by a chromogenic in situ hybridization RNAscope assay and assigned an H-score (0-300) (Flagship Biosciences, Broomfield, CO; Advanced Cell Diagnostics, Newark, CA) Primary efficacy endpoint: objective response rate (ORR) Secondary efficacy endpoints: duration of response (DoR), disease control rate (DCR), progression- free survival (PFS) and overall survival (OS) Analysis population: modified intent to treat (mITT) population (completed > 1 dose DKN-01) Analysis by DKK1 expression: comparison between DKK1- high (H-score ≥35) and DKK1-low groups .. 25 GEA patients were enrolled → 17 patients (68%) had gastroesophageal junction (GEJ) adenocarcinoma → 8 patients (32%) had gastric cancer (GC) .. 21 patients had RNAscope DKK1 expression available → 12 patients (57%) DKK1-high (8 GEJ, 4 GC) → 9 patients (43%) DKK1-low (7 GEJ, 2 GC) Abstract # 2218 RESULTS METHODS BACKGROUND Dickkopf-1 (DKK1) .. DKK1 modulates Wnt signaling1 .. Overexpression of DKK1 is linked to poor prognosis1 .. Tumor cells secrete DKK1 promoting proliferation, metastasis and angiogenesis1 .. DKK1 suppresses anti-tumor immune responses through the downregulation of NK cell function and enhancement of MDSC activity2,3 .. Promotes activation of Akt signaling through CKAP4 receptor4 Demographic & Clinical Characteristics .. mITT population included 22 patients; response evaluable (RE) mITT population was 21 patients .. ORR in mITT was 68.2% (15 PR, 6 SD, 1 NE) and DCR was 96% .. DKK1-high mITT ORR was 90%; 7 of 9 responders still on therapy .. DKK1-low mITT ORR was 55.6%; 4 of 5 responders still on therapy .. Median DoR and PFS were not reached Best Overall Response by DKK1 Expression Safety .. In the RE mITT, similar ORR regardless of PD-L1 vCPS score (<5 vs ≥5) overall (79% vs 67%) and in DKK1-high patients (100% vs 75%), respectively .. Double negative patients (DKK1-low and PD-L1 vCPS <5) have an ORR 57% DKK1 RNAscope Tumor Biopsy Examples DisTinGuish Trial Part A* First-line DKN-01 + Tislelizumab + CAPOX in Advanced GEA (NCT04363801) DKN-01 + tislelizumab + CAPOX was well tolerated and has encouraging response rates as first-line treatment for advanced GEA .. Improved ORR outcomes in the overall population compared to current standard of care in an unselected PD-L1 population .. Efficacy driven by enhanced ORR in the DKK1-high patients, an aggressive subpopulation .. All 9 RE mITT DKK1-high patients had partial responses .. Response correlates with DKK1 expression and is independent of PD-L1 expression .. Duration of response and progression-free survival data are not yet mature, expected in first half of 2022 CONCLUSIONS References: 1. Kagey MH, He X. Br J Pharmacology. 2017;174:4637–4650. 2. Malladi S, et al. Cell. 2016;165:45–60. 3. D’Amico L, et al. J Exp Med. 2016;213(5):827–840. 4. Kimura H, et al. J Clin Invest. 2016;126(7):2689–2705. 5. Haas M, et al. Mol Cancer Res. 2021;19:717–25. DKK1-high Patient (H-score = 108) DKK1-high Patient (H-score = 108) DKK1-low Patient (H-score = 4) DKK1-low Patient (H-score = 4) DKN-01 .. Humanized monoclonal antibody [IgG4] targeting DKK1 .. Activates innate immune response in preclinical models characterized by increased infiltration of NK cells and reduced MDSC function5 .. In vivo, DKN-01 downregulates Akt activity and upregulates PD-L1 expression in tumors5 .. DKN-01 in combination with the anti-PD1 antibody, pembrolizumab, has demonstrated safety and clinical activity in advanced, previously treated DKK1-high GEA; high tumoral DKK1 expression was associated with longer PFS (22.1 weeks vs 5.9 weeks)6 .. Tislelizumab is a PD-1 mAb with high affinity and specificity for PD-1, designed to minimize binding to FcγR on macrophages and thereby potentially avoid antibody-dependent phagocytosis.7 .. We report response and survival outcomes in GEA patients treated with a DKN-01 combined with tislelizumab and chemotherapy as first-line therapy. Image from: Chu HY, et al. Front Immunol. 2021;12:658097 *The DisTinGuish Trials has two parts. Part A is reported here. Part B is evaluating second-line treatment with 300 or 600 mg DKN- 01 + tislelizumab in locally advanced/metastatic DKK1-high gastric or gastroesophageal adenocarcinoma patients who have received only one prior systemic treatment with a platinum + fluoropyrimidine–based therapy (±HER2 therapy, if applicable). **Safety review after the first 5 patients have enrolled and completed one cycle 21-day cycles Screening ≤28 days Day 1 Day 15 Day 21** EOT 30-day follow-up Long-term follow-up every 12 weeks DKN-01 300 mg DKN-01 300 mg Tislelizumab 200 mg Oxaliplatin 130 mg/m2 Capecitabine 1000 mg/m2 BID Disposition & Exposure .. Mean duration of treatment: 5 months .. Longest duration to date on study: 10+ months .. 16 patients remain on therapy Poster # 1384P Overall N=25 Number of cycles, median (min, max) 7.0 (1.0, 14.0) Duration on treatment (months), median (min, max) 5.1 (0.8, 10.1) Reasons for study drug discontinuation, n (%) Patient request to withdraw 2 (8) Objective disease progression 3 (12) Adverse event 3 (12) Other reasons 1 (4) Reasons for study discontinuation, n (%) Withdrawal of consent 0 Death 4 (16) Duration on study (months): median, (min, max) 5.6 (1.4, 10.4) Best Overall Response, n (%) Partial Response Stable Disease Progressive Disease Non-Evaluable mITT population (N=22) 15 (68.2%) 6 (27.3%) 0 1 (4.5%) DKK1-high (N=10) 9 (90.0%) 0 0 1 (10.0%) DKK1-low (N=9) 5 (55.6%) 4 (44.4%) 0 0 DKK1 unknown (N=3) 1 (33.3%) 2 (66.7%) 0 0 Overall N=25 DKK1-high (H-score ≥35) N=12 DKK1-low (H-score <35) N=9 DKK1 Unknown N=4 Age, median (min, max) 61.0 (22.0, 80.0) 62.5 (22.0,71.0) 56.0 (35.0,80.0) 65.0 (36.0, 80.0) Gender (male), n (%) 19 (76) 8 (67) 8 (89) 3 (75) ECOG Performance Status, n (%) 0 14 (56) 6 (50) 5 (56) 3 (75) 1 11 (44) 6 (50) 4 (44) 1 (25) GEJ Adenocarcinoma 17 (68) 8 (67) 7 (78) 2 (50) Stage at Initial Diagnosis, n (%) Stage I 1 (4) 1 (8) 0 0 Stage III 3 (12) 1 (8) 2 (22) 0 Stage IV 9 (36) 6 (50) 3 (33) 0 Unknown 4 (16) 0 2 (22) 2 (50) Months Since First Diagnosis, median 1.2 (0.2, 20.3) 1.0 (0.6, 2.4) 1.0 (0.2, 7.1) 10.9 (1.4, 20.3) GC Adenocarcinoma, n (%) 8 (32) 4 (33) 2 (22) 2 (50) Stage at Initial Diagnosis Stage III 1 (4) 0 1 (11) 0 Stage IV 7 (28) 4 (33) 1 (11) 2 (50) Months Since First Diagnosis, median 0.7 (0.4, 25.0) 0.6 (0.4, 0.7) 12.9 (0.8, 25.0) 0.4 (0.3, 0.6) Prior Systemic Therapies, n (%) Adjuvant 2 (8) 0 1 (11) 1 (25) Neoadjuvant 2 (8) 0 2 (22) 0 Adjuvant/neoadjuvant 3 (12) 0 2 (22) 1 (25) Tumor PD-L1: vCPSa, n (%) 22 (88) 12 (100) 9 (100) 1 (25) CPS < 1 5 (23) 2 (17) 2 (22) 1 (100) CPS <5 16 (73) 8 (67) 7 (78) 1 (25) CPS ≥5b 6 (27) 4 (33) 2 (22) 0 Tumor Mutation Burden,c n (%) 15 (60) 7 (58) 7 (78) 1 (25) <10 13 (87) 5 (71) 7 (100) 1 (100) ≥10 2 (13) 2 (29) 0 0 Missing 10 (40) 5 (42) 2 (22) 3 (75) Microsatellite status,c n (%) 15 (60) 7 (58) 7 (78) 1 (25) Microsatellite Stability (MSS) 15 (100) 7 (100) 7 (100) 1 (100) Missing 10 (40) 5 (42) 2 (22) 3 (75) avCPS: visually-estimated Combined Positive Score, also known as Tumor Area Positivity (TAP) score (Ventana Medical Systems, Oro Valley, AZ). bTwo patients had vCPS ≥10. cTumor Mutation Burden and Microsatellite status was determined from plasma ctDNA using the FoundationOne Liquid CDx assay (Foundation Medicine, Cambridge, MA). Best Overall Response by PD-L1 and DKK1 Expression vCPS: Visually-Estimated Combined Positive Score PD-L1: Programmed Death-Ligand 1 Correlation of DKK1 RNAscope H-score with vCPS vCPS: Visually-Estimated Combined Positive Score; PD-L1: Programmed Death-Ligand 1 .. Tumoral DKK1 expression is predictive of response to DKN-01 therapy -100 -50 0 50 100 Best % Change in Sum of Diameters Subjects Part A (N=21) SD SD SD SD SD SD PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR + ++ +++ + ++ ???–– –– – –– –– Association of DKK1 Expression with Response .. DKK1 and PD-L1 expression are not correlated Best Overall Response, n (%) Partial Response Stable Disease Progressive Disease Non-Evaluable PD-L1 CPS ≥5 (N=6) 4 (67%) 1 (17%) 0 1 (17%) DKK1-high (N=4) 3 (75%) 0 0 1 (25%) DKK1-low (N=2) 1 (50%) 1 (50%) 0 0 PD-L1 CPS <5 (N=14) 11 (79%) 3 (21%) 0 0 DKK1-high (N=6) 6 (100%) 0 0 0 DKK1-low (N=7) 4 (57%) 3 (43%) 0 0 DKK1 unknown (N=1) 1 (100%) 0 0 0 Disclosures: Dr. Klempner reports consulting/advisory fees from Merck, BMS, Eli Lilly, Natera Oncology, Pieris, Foundation Medicine, and stock/equity in Turning Point Therapeutics. Acknowledgements: The authors thank the patients, families and physician investigators who participated in the DisTinGuish trial. Poster design and creation by Laurie LaRusso, MS, ELS, Chestnut Medical Communications. Sectioned slides from tumor specimens were stained for DKK1 mRNA at Flagship Biosciences (Broomfield, CO) and expression was quantified using a digital image analysis algorithm.8 Blue circles (no DKK1 staining), yellow circles (low DKK1 staining), orange circles (medium DKK1 staining) and red circles (high DKK1 staining). An H-score was calculated by determining the percentage of cells expressing low, medium and high levels of DKK1 with the following formula. H-score = (%low)+2*(%medium)+3*(%high). H-score range: 0 to 300. Part A Patients N=25 Preferred Terms No Patients % Death within 30 days of last dose 3 12% Any adverse event 25 100% Grade ≥ 3 events 13 52% DKN-01-related 5 20% Serious adverse events 7 28% DKN-01-related 2 8% Events leading to DKN-01 discontinuation 3 12% DKN-01-related 1 4% Events leading to DKN-01 dose reduction 1 4% Drug-related adverse events DKN-01-related 14 56% Tislelizumab-related 16 64% Capecitabine-related 23 92% Oxaliplatin-related 22 88% Regimen-related 23 92% Summary of Adverse Events Part A Patients N=25 Preferred Terms No Patients % DKN-01 Related Fatigue 8 32% Nausea 5 20% Diarrhoea 5 20% Neutrophil count decreased 5 20% Platelet count decreased 5 20% Hemoglobin decreased 4 16% Decreased appetite 3 12% Headache 3 12% DKN-01 Related Grade ≥ 3 5 20% Diarrhoea 1 4% Neutrophil count decreased 1 4% Blood phosphorus decreased 1 4% Pulmonary embolism 2 8% Any DKN-01+Tislelizumab regimen- related Grade ≥ 3 9 36% Diarrhoea 3 12% DKN-01 Related Adverse Events with ≥10% Incidence .. Most common DKN-01-related adverse events: fatigue, nausea, diarrhoea, neutrophil count decreased, platelet count decreased .. Grade ≥3 DKN-01-related adverse events (5 patients): diarrhoea (1), neutrophil count decreased (1), blood phosphorus decreased (1), pulmonary embolism (2) .. Grade 5: pulmonary embolism (1) CPS Status: ≥5 <5 Unknown Tumor DKK1-RNAscope H-Score Status: + High (≥35) – Low (<35) ? Unknown H-score = 35 H-score difference in PR vs. SD Wilcoxon (1-sided) p-value 0.075 H-score = 35 Tumor type: GEJ adenocarcinoma Gastric adenocarcinoma -100 -50 0 50 100 Best % Change in Sum of Diameters Subjects Part A (N=21) SD SD SD SD SD SD PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR DKK1 RNAscope H-score Status: High (≥35) Low (<35) Unknown Tumor type: GEJ adenocarcinoma Gastric adenocarcinoma % Change from Baseline in Sum of Diameters Subjects Who Received Study Drug 6. Klempner SJ, et al. Mol Cancer Ther. 2021. In press. 7. Zhang T, et al. Cancer Immunol Immunother. 2018;67:1079–90. 8. Caldwell C, et al. Sci Rep. 2021;11:9920. |
