Data presented at the American Society of Clinical Oncology’s annual meeting – May 29-31

Company Product Description Indication Status
Ascentage Pharma Group International, of Suzhou, China APG-115 MDM2-p53 inhibitor Metastatic solid tumors Data from phase Ib portion of phase Ib/II trial in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) showed antitumor effects among 18 evaluable patients, including 1 with confirmed complete response lasting for 20 months (still ongoing); 2 had confirmed partial response for 8 to 9 months; 7 had stable disease for 1.5 to 7 months; objective response rate was 16.7% and disease control rate was 55.5%
Ascentage Pharma Group International, of Suzhou, China APG-115 MDM2-p53 inhibitor Advanced liposarcoma and other solid tumors Phase I data in Chinese patients showed 1 of 19 evaluable patients had partial response, and 12 had stable disease; the objective response rate was 5.3% and disease control rate was 68.4%; in patients with liposarcoma and wild-type TP53 (n=9), ORR was higher, reaching 11.1%, with DCR of 77.8%
Ascentage Pharma Group International, of Suzhou, China APG-1387 IAP inhibitor Advanced solid tumors Phase Ib data showed combination with Keytruda (pembrolizumab, Merck & Co. Inc.), among 37 evaluable patients, resulted in 4 patients with partial responses (2 non-small-cell lung cancer, 1 colorectal cancer and 1 breast cancer) and 12 with stable disease; overall objective response rate was 10.8% and disease control rate was 43.2%; NSCLC cohort achieved 50% ORR and 100% DCR, while CRC cohort achieved 50% DCR with 1 PR and 3 durable SD
Celyad SA, of Mont-Saint-Guibert, Belgium CYAD-101 T-cell receptor inhibitory molecule-based non-gene edited allogeneic CAR T candidate Metastatic colorectal cancer Data from phase I Alloshrink trial showed antitumor activity, with 2 patients achieving confirmed partial response according to RECIST 1.1 criteria, including 1 with KRAS-mutation; 9 patients achieved stable disease, with 7 demonstrating disease stabilization lasting more than or equal to 3 months of duration; 15 patients enrolled to date
Engeneic Ltd., of New York EGFR-targeted EDV nanocells Immunotherapy Recurrent, metastatic pancreatic cancer Interim phase I/IIa data show early signs pointing to durable response, possibly related to development of an innate and adaptive immune response as a result of direct cytotoxic effects on drug-resistant tumor cells
Faron Pharmaceutical Oy, of Turku, Finland Clevegen (FP-1305) Immunotherapy targeting Clever-1-positive tumor-associated macrophages Metastatic or inoperable solid tumors Results from part 1 of ongoing phase I/II Matins study showed drug was well-tolerated, without dose-limiting toxicities; Clever-1 inhibition led to immune cell activation and down-regulation of several checkpoint molecules; interferon-gamma and chemokine CXCL10 responses were associated with clinical responses observed in target or non-target lesions
Immutep Ltd., of Sydney Eftilagimod alpha (IMP-321) Soluble LAG-3 Head and neck squamous cell carcinoma or non-small-cell lung cancer Interim data from phase II Tacti-002 study testing combination with Keytruda (pembrolizumab, Merck & Co. Inc.) showed 1 second-line HNSCC patient achieved a complete response, bringing total response rate to 39% in that arm; in first-line NSCLC, improving overall response rate was 53%, with 9 of 17 patients reporting partial response, and 71% (12/17) had target lesion decrease; 41% of patients still on treatment at cutoff, indicating estimated median progression-free survival more than 9 months
Immutep Ltd., of Sydney Eftilagimod alpha (IMP-321) Soluble LAG-3 Solid cancers Interim data from phase I Insight-004 trial showed combination with avelumab resulted in 33% (4 of 12) patients with partial response (PR) according to RECIST 1.1; encouraging single PR cases, with 1 in esophagogastric junction carcinoma, 1 in colon adenocarcinoma, 1 in squamous cell anal carcinoma and 1 in pleural 
Innovent Biologics Inc., of Suzhou, China Tyvyt (sintilimab) PD-1 inhibitor Relapsed or refractory extranodal NK/T-cell lymphoma (nasal type) 2-year follow-up results from phase II Orient-4 study showed objective response rate of 67.9% and complete response rate of 14.3%; disease control rate was 85.7% and median overall survival not yet reached
Innovent Biologics Inc., of Suzhou, China Tyvyt (sintilimab) and IBI-305 PD-1 inhibitor and anti-VEGF antibody (bevacizumab biosimilar) Advanced hepatocellular carcinoma Preliminary phase Ib data showed 7 of 29 patients in low-dose group had confirmed partial response, with objective response rate of 24.1%; 6 of 18 subjects in high-dose group at PR (1 unconfirmed, 5 confirmed), with an ORR of 33.3%
Innovent Biologics Inc., of Suzhou, China, and Eli Lilly and Co., of Indianapolis Tyvyt (sintilimab) PD-1 inhibitor Relapsed or refractory classic Hodgkin lymphoma Results from phase II Orient-1 study showed, as of Sept. 30, 2019, data cutoff, objective response rate was 85.4% (82/96), of which 41 patients (42.7%) achieved complete response
Innovent Biologics Inc., of Suzhou, China, and Eli Lilly and Co., of Indianapolis Tyvyt (sintilimab) PD-1 inhibitor Locally advanced or metastatic esophageal squamous cell carcinoma Data from phase II Orient-2 study showed, as of Aug. 2, 2019, sintilimab demonstrated statistically significant improvement in overall survival vs. paclitaxel/irinotecan in intent-to-treat (ITT) population (p=0.032); median OS was 7.2 months vs. 6.2 months and 12-month OS rates were 37.4% and 21.4%, respectively
Kazia Therapeutics Ltd., of Sydney Paxalisib (GDC-0084)  PI3K/mTOR inhibitor Glioblastoma Interim phase II data from stage 1 (n=9) showed median overall survival of 17.7 months, progression-free survival of 8.4 months vs. existing standard-of-care temozolomide, which has reported median OS of 12.7 months and PFS of 5.3 months; longest-treated patient remains on therapy and progression-free some 19 months after diagnosis
Nanobiotix SA, of Paris NBTXR-3 Designed to destroy tumors through physical cell death when activated by radiotherapy Locally advanced head and neck cancer Updated data from phase I expansion study in elderly patients ineligible for chemotherapy or intolerant to cetuximab showed, for 30 evaluable patients, at a median time of 5 months after injection, an overall objective response rate of 83%, an overall complete response rate of 43% and objective response rate of primary tumor of 83% with a complete response rate of the primary tumor of 60%
Nkmax America Inc., of Santa Ana, Calif. SNK-01 Autologous non-genetically modified natural killer cells with enhanced cytotoxicity Stage IV non-small-cell lung cancer Data from phase I/IIa study, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) showed overall response rate via RECIST 1.1 of 44%, with 8-month progression-free survival; median overall survival not yet met; patients treated with highest dose of NK cells had 50% ORR; among patients with PD-L1 expression 1 - 50%, the overall response rate in the combination group was 40%
Taiho Oncology Inc., of Princeton, N.J. Futibatinib (TAS-120) Small-molecule inhibitor of FGFR1, 2, 3 and 4 Intrahepatic cholangiocarcinoma Interim analysis form phase II study in patients whose disease harbors FGFR2 gene fusions or other rearrangements who have failed at least 1 line of therapy showed, for 67 patients with minimum of 6 months follow-up, objective response rate was 37.3% (1 complete response and 24 partial responses); median duration of response was 8.31 months
Treos Bio Ltd., of London Polypepi-1018 Off-the-shelf multipeptide treatment Microsatellite stable metastatic colorectal cancer Data from phase I/II Oberto study testing add-on to fluoropyrimidine/bevacizumab maintenance therapy after first-line induction chemotherapy showed treatment was safe and well-tolerated and produced robust immune response against multiple tumor antigens; multi-antigenic CD8+ T-cell responses detected for 80% of patients, exceeding the immune response rates reported for personalized neoantigen immunotherapies; among 4 patients that had serial liver biopsies performed, increased immune cell infiltration was detected, which confirmed the conversion of previously immunologically cold tumors into hot tumors
VBL Therapeutics Ltd., of Tel Aviv, Israel VB-111 (ofranergene obadenovec) Gene therapy Platinum-resistant ovarian cancer Outcome of preplanned interim analysis from phase III Oval study showed CA-125 objective response rate of 53% among first 60 evaluable patients; assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was 58% or higher; in patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%

Notes

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