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

Company Product Description Indication Status
Allogene Therapeutics Inc., of South San Francisco, and Les Laboratoires Servier SAS, of Paris ALLO-501 B-lymphocyte antigen CD19 modulator Non-Hodgkin lymphoma Data on first 9 participants with relapsed/refractory disease from phase I Alpha study with escalating doses of ALLO-501 and lower dose (39 mg) CD52 modulator ALLO-647 showed overall response rate of 78% with 3 complete responses and 4 partial responses; at January 2020 data cutoff, median follow-up was 2.7 months with 4 patients in ongoing response and 3 progressed at 2, 4 and 6 months
Arvinas Inc., of New Haven, Conn. ARV-110 Androgen receptor antagonist Metastatic castration-resistant prostate cancer Initial data from dose-escalation portion of phase I/II study showed 2 participants with ongoing confirmed prostate-specific antigen responses, including 1 with unconfirmed partial tumor response
Exelixis Inc., of Alameda, Calif. Cabometyx (cabozantinib) Multityrosine kinase inhibitor Advanced solid tumors In Phase Ib Cosmic-021 combination trial with PD-L1 inhibitor atezolizumab (Tecentriq, Roche Holding AG), non-small-cell lung cancer expansion cohort (n=30), at median follow-up of 12.1 months, showed investigator-assessed confirmed objective response rate (ORR) per RECIST v. 1.1, the primary endpoint, of 27% and disease control rate of 83%; median progression-free survival (PFS) was 4.2 months with 22 events (73%) and median duration of response for responding patients of 5.7 months; in urothelial carcinoma expansion cohort (n=30), investigator-assessed ORR per RECIST v. 1.1 was 27%, with 2 complete responses; disease control rate was 63% and median duration of response was not reached, with longest ongoing response of 15.6 months and median PFS of 5.4 months
Galera Therapeutics LLC, of Malvern, Pa. Avasopasem manganese (GC-4419) Superoxide dismutase mimetic Radiation-induced severe oral mucositis in patients with locally advanced head and neck cancer Retrospective analysis of a phase IIb study showed the 90-mg dose significantly reduced the incidence and severity of cisplatin-induced chronic kidney disease compared to placebo
Heat Biologics Inc., of Durham, N.C. HS-110 Allogeneic cell-based therapy Advanced non-small-cell lung cancer Updated data from phase II trial in combination with Opdivo (nivolumab, Bristol Myers Squibb Co.) in previously treated, checkpoint inhibitor-naïve patients showed median overall survival of 28.7 months, with median follow-up of 15.7 months; 21 of 47 patients enrolled were still alive as of data cutoff
Helsinn Group, of Lugano, Switzerland, and MEI Pharma Inc., of San Diego Pracinostat Pan-histone deacetylase inhibitor High and very-high risk myelodysplastic syndromes previously untreated with hypomethylating agents In a 64-patient phase II study, pracinostat plus azacitidine produced a median overall survival of 23.5 months; 1-year OS was 77%; overall response rate was 33%, all of which were complete responses (CR); clinical benefit rate (CR, mCR plus hematologic improvement (HI), mCR with no HI or HI with no mCR) was 77%
Immunogen Inc., of Waltham, Mass. Mirvetuximab soravtansine Antibody-drug conjugate targeting folate receptor alpha Recurrent ovarian cancer with medium and high folate receptor alpha expression Initial data from 60 evaluable patients in the phase Ib/II Forward II study showed mirvetuximab soravtansine plus Avastin (bevacizumab, Roche Holding AG) produced a confirmed overall response rate of 43%; in 33 patients with high folate receptor alpha expression, ORR was 61%; duration of response and progression-free survival data are immature
Innate Pharma SA, of Marseille, France, and Astrazeneca plc, of Cambridge, U.K. Monalizumab Monoclonal antibody targeting NKG2A receptor Recurrent or metastatic head and neck squamous cell cancer after treatment with platinum-based chemotherapy and PD-(L)1 inhibitors In the phase II expansion cohort treated with monalizumab plus Erbitux (cetuximab, Eli Lilly and Co.), 40 patients had an overall response rate of 20%
Innovent Biologics Inc., of Suzhou, China, and Eli Lilly and Co., of Indianapolis Tyvyt (sintilimab) Monoclonal antibody targeting PD-1 Second-line advanced or metastatic esophageal squamous cell carcinoma The 190-patent phase II Orient-2 study met its primary endpoint of overall survival
Inovio Inc., of Plymouth Meeting, Pa. INO-5401 and INO-9012 DNA-based immunotherapies Glioblastoma multiforme Data from phase I/II study showed 85% (44 of 42) of newly diagnosed patients who received combination of immunotherapies plus PD-1 inhibitor Libtayo (cemiplimab, Regeneron Pharmaceuticals Inc./Sanofi SA) were alive for at least 12 months or more following treatment
Janssen Pharmaceutical Co., of Beerse, Belgium, a unit of New Brunswick N.J.-based Johnson & Johnson Erleada (apalutamide) Androgen receptor inhibitor Non-metastatic castration-resistant prostate cancer In the 1,207-patient phase III Spartan study, Erleada plus androgen deprivation therapy (ADT) produced a median overall survival of 73.9 months, compared to 59.9 months for ADT alone, including patients who crossed over to Erleada (p=0.0161); combination delayed time to treatment with cytotoxic chemotherapy compared to ADT alone (p=0.0002)
Janssen Pharmaceutical Co., of Beerse, Belgium, a unit of New Brunswick N.J.-based Johnson & Johnson, and Legend Biotech Corp., of Somerset, N.J. JNJ-4528 CAR T targeting B-cell maturation antigen Relapsed or refractory multiple myeloma Long-term follow-up of 29 patients in the phase Ib portion of the phase Ib/II study showed a 100% overall response rate with 86% achieving a  complete response; 9-month progression-free survival was 86%
Marker Therapeutics, Inc., of Houston MultiTAA T-cells Autologous T cells targeting PRAME, SSX2, MAGEA4, NY-ESO-1 and Survivin Advanced or metastatic pancreatic adenocarcinoma with cancer control after 3 months of standard chemotherapy Of 13 treated patients, 8 maintained cancer control for longer than historical controls, including 3 partial responses and 1 radiographic complete response
MEI Pharma Inc., of San Diego, and Kyowa Kirin Co. Ltd., of Tokyo ME-401  Phosphatidylinositol 3-kinase delta inhibitor Relapsed or refractory follicular lymphoma  In a phase Ib study, an intermittent dosing schedule of ME-401 produced an 83% overall response rate; median response rate not met after a median follow-up of 13.2 months
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 therapy Metastatic triple-negative breast cancer Phase III Keynote-355 trial demonstrated statistically significant improvement in progression-free survival (PFS) when used in addition to chemotherapy vs. chemotherapy alone in certain patients; reduced the risk of disease progression or death by 35% and improved PFS to a median of 9.7 months compared to 5.6 months in those whose tumors expressed PD-L1 with combined positive score (CPS) ≥10; tumors expressing PD-L1 with CPS ≥1, it improved median PFS by 7.6 months vs. 5.6 months, which did not meet statistical significance
Merck & Co. Inc., of Kenilworth, N.J. MK-6482 Hypoxia-inducible factor-2 alpha inhibitor Von Hippel-Lindau disease-associated clear cell renal cell carcinoma Phase II data demonstrated durable responses with a confirmed objective response rate of 27.9%; the median duration of response was not yet reached in the range of 9.1 to 39 weeks; patients received 120 mg orally once daily until disease progression, unacceptable toxicity or withdrawal; as of data cutoff, 95.1% of patients were still on therapy
Targovax ASA, of Oslo, Norway ONCOS-102 Oncolytic adenovirus Primary ovarian and colorectal cancer  Abstract for phase I/II trial in combination with checkpoint inhibitor durvalumab in patients with platinum-resistant ovarian or colorectal cancers that have metastasized to the peritoneal cavity indicate treatment is triggering immune activation and has clinical activity
Tarveda Therapeutics Inc., of Watertown, Mass. PEN-866 Hsp90 binding miniature drug conjugate that binds to activated Hsp90 and is linked to the topoisomerase 1 inhibitor SN-38 Advanced solid tumor malignancies Phase I dose-escalation portion of a phase I/IIa study showed it was well-tolerated, demonstrated a high therapeutic index, and had evidence of antitumor activity across multiple tumors and dose ranges, including 1 partial response; data also confirm a favorable pharmacokinetic profile 
Tiziana Life Sciences plc, of New York and London Milciclib A small-molecule pan-inhibitor of cyclin dependent kinases Advanced hepatocellular carcinoma Phase IIa data of milciclib in sorafenib-resistant HCC showed it met the primary endpoint that oral treatment was well-tolerated with manageable toxicities and had no drug-related deaths; median time to progression and progression-free survival were both 5.9 months; a second abstract of milciclib and regorafenib in liver transplant patients with recurrent HCC showed mean AFP levels reduced by about 20% within 1 month of treatment
Vaximm AG, of Basel, Switzerland, and Mannheim, Germany VXM-01 Oral T-cell immunotherapy; targets VEGFR2; based on live attenuated bacterial vaccine strain Progressive glioblastoma Phase I/II data of VXM-01 in combination with the PD-L1 inhibitor avelumab demonstrated 3 objective responses from the first 9 patients; 2 of the responding patients are progression-free 6 months out; the combination was safe and produced specific immune responses
Xencor Inc., of Monrovia, Calif. XmAb-20717 A PD-1 and CTLA4 bispecific antibody Advanced solid tumors Phase I data showed that in the first 6 dose-escalation cohorts, it was generally well-tolerated in heavily pretreated patients and had dose-dependent increases in T-cell activation biomarkers; 1 patient out of 7 receiving the highest dose of 10 mg/kg achieved a confirmed complete response; expanded study to enroll patients into additional escalation cohorts, up to 20-mg/kg dose levels; those treated have advanced non-small-cell lung cancer, renal cell carcinoma, prostate cancer and other cancers

Notes

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