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

Company Product Description Indication Status
Adaptimmune Pharmaceuticals plc, of Oxfordshire, U.K.  Specific Peptide Enhanced Affinity Receptor T cells Targets MAGE-A4  Synovial sarcoma Durability and responses demonstrated
Affimed NV, of Heidelberg, Germany AFM-13 Innate cell engager T-cell lymphoma or transformed mycosis fungoides Outlined Redirect trial design; registration-directed phase II study to test drug in patients with relapsed or refractory CD30-positive PTCL or TMF actively recruiting
Agios Pharmaceuticals Inc., of Cambridge, Mass. Vorasidenib  Dehydrogenase inhibitor Isocitrate dehydrogenase-mutant advanced solid tumors, including glioma Demonstrated prolonged disease control and encouraging preliminary activity with median progression-free survival of 31.4 months in phase I trial
Alx Oncology Holdings Inc., of Burlingame, Calif. ALX-148 CD47 antagonist Advanced solid tumors In phase I study, 20 participants with squamous cell carcinoma of head and neck (HNSCC) who progressed on first-line therapy, dosed with study drug plus pembrolizumab (Keytruda, Merck & Co. Inc.) showed objective response rate (ORR) of 20% and disease control rate of 30%; those with HNSCC and no prior checkpoint inhibitor therapy (n=10) showed ORR of 40%, median progression-free survival (PFS) of 4.61 months and median overall survival (OS) not reached at median follow-up of 17.9 months; 19 with HER2-positive gastric/gastroesophageal junction cancer who progressed on first-line therapy, dosed with study drug plus trastuzumab (Herceptin, Roche Holding AG), had ORR of 21%, median PFS of 2.17 months and median OS of 11.5 months
Amgen Inc., of Thousand Oaks, Calif. AMG-510 KRAS GTPase inhibitor Solid tumors In 960-mg once-daily target dose cohort in phase I study in 42 pretreated patients with advanced KRAS G12C-mutant colorectal cancer, at data cutoff of January 2020, objective response rate was 12% (3/25) and disease control rate was 80% (20/25); median progression-free survival was 4.2 months and overall survival was not reached after median follow-up of about 8 months; tumor shrinkage observed in 11 of 23
Amphivena Therapeutics Inc., of South San Francisco AMV-564 CD3/CD33 modulator Advanced solid tumors In phase I dose-escalation trial in 18 participants, study drug showed no dose-limiting toxicities; 1 complete response seen in heavily pretreated checkpoint inhibitor-refractory ovarian cancer patient, with treatment ongoing
Arvinas Inc., of New Haven, Conn. ARV-110 Androgen receptor antagonist; ubiquitin ligase modulator Metastatic castration-resistant prostate cancer Dose-escalation portion of phase I/II trial in 20 evaluable participants showed 1 of 2 with confirmed PSA responses had 74% PSA decline from baseline and remained progression-free after 30 weeks; second had 97% decline from baseline and confirmed RECIST response (80% decrease from baseline in tumor mass) and remained progression-free after 18 weeks; both responses were in 140-mg dose cohort
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab) Monoclonal antibody targeting PD-L1 First-line extensive-stage small-cell lung cancer Long-term follow-up from the phase III Caspian study showed Imfinzi plus chemotherapy produced an overall survival of 12.9 months vs. 10.5 months for chemotherapy alone (p=0.0032); 2-year OS was 22.2% for combination vs.14.4% for chemotherapy; 2-year progression-free survival was 11% for combination vs 2.9% for chemotherapy
Astrazeneca plc, of Cambridge, U.K. Tagrisso (osimertinib) EGFR antagonist; protein tyrosine kinase inhibitor Non-small-cell lung cancer In phase III Adaura trial in early-stage EGFR-mutated disease, primary endpoint of disease-free survival (DFS) with adjuvant treatment was 83% (p<0.0001); secondary endpoint of DFS in overall population was 79% (p<0.0001); at 2 years, 89% treated with Tagrisso remained alive and disease free vs. 53% on placebo
Astrazeneca plc, of Cambridge, U.K. Tremelimumab Monoclonal antibody targeting CTLA4 Advanced hepatocellular carcinoma In the phase II Study 22, 300-mg tremelimumab plus Imfinzi (durvalumab) produced a median overall survival of 18.73 months compared to 13.57 months for Imfinzi alone, 15.11 months for tremelimumab alone and 11.3 months for 75-mg tremelimumab plus Imfinzi; objective response rates were 24%, 10.6%, 7.2% and 9.5% for 300-mg tremelimumab plus Imfinzi (durvalumab), Imfinzi alone, tremelimumab alone and 75-mg tremelimumab plus Imfinzi, respectively
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (fam-trastuzumab deruxtecan-nxki) Antibody-drug conjugate targeting HER2 HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma In the phase II Destiny-Gastric01 study in patients who progressed on 2 or more treatments, Enhertu produced a confirmed overall response rate of 42.9% compared to 12.5% for chemotherapy (p<0.001); median overall survival was 12.5 months on Enhertu vs. 8.4 months on chemotherapy 
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan)  ERBB-2 tyrosine kinase receptor inhibitor; topoisomerase I inhibitor Metastatic colorectal cancer In phase II Destiny-CRC01 trial in 53 evaluable patients with HER2-positive disease, primary endpoint of confirmed objective response rate was 45.3% with study drug as monotherapy (6.4 mg/kg); disease control rate was 83% with median progression-free survival of 6.9 months; median duration of response and overall survival were not reached at data cutoff of Aug. 9, 2019
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan)  ERBB-2 tyrosine kinase receptor inhibitor; topoisomerase I inhibitor Non-small-cell lung cancer At interim analysis of ongoing phase II Destiny-Lung01 trial in 42 evaluable patients with HER2-mutant metastatic disease, primary endpoint of confirmed objective response rate was 61.9% for study drug as monotherapy (6.4 mg/kg), with disease control rate of 90.5% and estimated median progression-free survival of 14 months; median duration of response and overall survival were not reached at data cutoff of Nov. 25, 2019
Athenex Inc., of Buffalo, N.Y. Encequidar + oral paclitaxel P-Glycoprotein 1 inhibitor Cutaneous angiosarcoma Interim phase II data in 22 evaluable participants with unresectable disease showed clinical benefit rate of 100%; all showed reduction in tumor size; complete responses seen in 27.3%, partial responses in 22.7% and stable disease in 50%
Autolus Therapeutics plc, of London AUTO-3 B-lymphocyte antigen CD19/CD22 modulator Diffuse large B-cell lymphoma In 23 evaluable participants in phase I/II Alexander study, at data cutoff of April 27, 2020, at dose of ≥ 150 x 106 cells across 2 dosing regimens for pembrolizumab (Keytruda, Merck & Co. Inc.), 11 of 16 achieved complete or partial response (overall response rate, or ORR=69%) and 9 of 16 achieved complete response (CRR=56%) with all 9 CRs ongoing at median follow-up of 3 months (range 1-12 months); at recommended phase II dose range of 150 - 450 x 106 cells with pembrolizumab on day 1, 6 of 8 participants achieved CR or PR (ORR=75%)
Aveo Pharmaceuticals Inc. (Aveo Oncology), of Cambridge, Mass. Tivozanib (Fotivda) VEGF receptor tyrosine kinase inhibitor Renal cell carcinoma  Final overall survival (OS) analysis of pivotal phase III Tivo-3 trial of study drug vs. sorafenib (Nexavar, Bayer AG) in third- and fourth-line disease had HR of 0.97 (p=0.82), improving from interim HR of 0.99; updated median OS was 16.4 months for tivozanib and 19.2 months for sorafenib 
Bayer AG, of Leverkusen, Germany Vitrakvi (larotrectinib) Tropomyosin receptor kinase inhibitor TRK fusion cancer Overall response rate was 71%, including 10% complete responses and 60% partial responses in 116 patients; median duration of response was 35.2 months; median progression-free survival was 25.8 months; 1-year overall survival was 87%
Beigene Ltd., of Beijing Tislelizumab Monoclonal antibody targeting PD-1 Advanced squamous non-small-cell lung cancer In the 360-patient phase III study, median progression-free survival was 7.6 months for both arms testing tislelizumab plus chemotherapy (arm A: paclitaxel and carboplatin or arm B: Abraxane and carboplatin) compared to 5.5 months for chemotherapy alone (p=0.0001 and p< 0.0001, respectively); objective response rates were 73% and 75% in arm A and arm B, respectively, vs. 50% for chemotherapy alone
Beigene Ltd., of Beijing Brukinsa (zanubrutinib) Bruton’s tyrosine kinase inhibitor Waldenström’s macroglobulinemia In the 201-patient phase III Aspen study, after 19.4 months of follow-up, 28.4% of patients treated with Brukinsa had a complete response or very good partial response, compared to 19.2% of patients treated with Imbruvica (ibrutinib) (p=0.0921); exploratory analysis after an additional 5 months of follow-up, showed CR+VGPR (investigator assessed) was 30.4% for Brukinsa compared to 18.2% for Imbruvica (p=0.0302)
Boundless Bio Inc., of San Diego Preclinical Extrachromosomal DNA Gastric tumors Study found that 32% of the 108 patients were positive for extrachromosomal DNA (ecDNA), a group that was mutually exclusive from the 23% of patients who showed high microsatellite instability; ecDNA+ tumors had statistically significantly lower tumor immune signature than all other molecular subtypes (p<0.05) except those with chromosomal instability (p=0.09); ecDNA+ tumors also had lower PD-L1 expression than all the other molecular subtypes but the genomically stable and chromosomal instability subtypes
Briacell Corp, of Berkeley, Calif. Bria-IMT  Immunotherapy  Advanced breast cancer In the phase I/IIa study, 71% of the 7 patients treated with Bria-IMT alone, who were also able to develop an immune response, experienced disease control, including 1 partial response; 3 patients treated with Bria-IMT plus a PD-1 inhibitor had disease control
Bridgebio Pharma Inc., of San Francisco, and its affiliate QED Therapeutics Infigratinib FGFR1-3 inhibitor Advanced/unresectable or metastatic urothelial carcinoma and cholangiocarcinoma In a phase II study, objective response rate was 25% for all 67 urothelial cancer patients, 31% for 13 patients receiving infigratinib as first-line treatment, 24% for 54 patients receiving infigratinib as a second-line or later treatment, and 50% for 8 patients with upper tract urothelial carcinoma who received infigratinib as second-line or later therapy; a retrospective analysis of patients with FGFR-fusion-positive cholangiocarcinoma showed median progression-free survival was 6.8 months for third- and later-line infigratinib treatment compared to 4.6 months when the same patients were treated with second-line chemotherapy
Cardiff Oncology Inc., of San Diego Onvansertib Polo-like-kinase 1 inhibitor Second-line KRAS-mutated metastatic colorectal cancer In the phase Ib portion of a Ib/II study where the maximum tolerated dose hasn't been reached, 4 of 9 patients had an objective response and 4 others had stable disease; progression-free survival is greater than 6 months with 6 patients remaining on therapy
Celltrion Inc., of Incheon, South Korea Herzuma Biosimilar of trastuzumab HER2-positive gastric cancer In the 43-patient phase Ib/II Panthera study, Herzuma plus Keytruda (pembrolizumab), capecitabine and cisplatin produced an overall response rate of 76.7%, including 16.3% complete responses and 60.5% partial responses; median progression-free survival was 8.6 months; median overall survival was 19.3%
Cytomx Therapeutics Inc., of South San Francisco, and Abbvie Inc., of North Chicago CX-2029 Probody-drug conjugate targeting CD71 Advanced solid tumors  In a phase I dose-escalation study, 3 confirmed partial responses were seen in 17 patients treated at doses 2 mg/kg or greater dose
Cytomx Therapeutics Inc., of South San Francisco CX-2009 Probody-drug conjugate targeting CD166 HER2-negative breast cancer In a phase I dose-escalation study, of the 26 patients who received 4 mg/kg or higher dose, there were 2 confirmed partial responses and 3 unconfirmed responses
Deciphera Pharmaceuticals Inc., of Waltham, Mass. Qinlock (ripretinib) Inhibits mutant KIT and PDGFRA kinases Fourth-line advanced gastrointestinal stromal tumor In the phase III Invictus study, drug increased patients’ self-reported health status on the EuroQol-5D visual analogue scale compared to a decline for placebo (p=0.004); physical and role function on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire improved for those on drug vs. a decline in patients receiving placebo (p=0.004, p=0.001, respectively); drug produced higher perceptions of overall health and quality of life compared with patients receiving placebo (both p=0.001)
Deciphera Pharmaceuticals Inc., of Waltham, Mass. Rebastinib TIE-2 kinase inhibitor Endometrial cancer In a phase Ib/II study, of the 18 patients treated with rebastinib plus paclitaxel, 7 had a partial response and 6 had stable disease
Effector Therapeutics Inc., of San Diego Tomivosertib (eFT-508) MNK1/2 inhibitor Non-small-cell lung cancer In a phase II study, demonstrated antitumor activity in combination with checkpoint inhibitors (CPI) in patients with solid tumors who progressed on CPI treatment; 41% of patients showed progression-free survival at 24 weeks; the median PFS rate was 19 weeks
Eisai Co. Ltd., of Tokyo Halaven (eribulin mesylate) and Keytruda (pembrolizumab) Microtubule dynamics inhibitor Metastatic triple-negative breast cancer  Updated results from the phase Ib/II Enhance 1 study showed no dose-limiting toxicities observed; of the total patients enrolled, the combination resulted in an overall objective response rate of 23.4%, the overall median progression-free survival was 4.1 months and median overall survival was 16.1 months  
EMD Serono, part of Merck KGaA, of Darmstadt, Germany Tepmetko (tepotinib) MET inhibitor Advanced non-small-cell lung cancer  Updated data from the ongoing phase II Vision study, also published in The New England Journal of Medicine, demonstrated an objective response rate of 46% among patients with METex14 skipping alterations, and 56% as assessed by investigators; the median duration of response was 11.1 months among patients with METex14 skipping alterations, and 14 months as assessed by investigators
Foundation Medicine Inc., of Cambridge, Mass., and Dana-Farber Cancer Institute  Comprehensive genomic profiling  CGP METex14-altered non-small-cell lung cancer Presented data showing that CGP identified co-occurring alterations that may cause treatment resistance in patients with METex14-altered NSCLC; in the analysis of more than 60,000 cases, researchers characterized a subset of 1,387 of patients (2.3%) with METex14-altered NSCLC and identified multiple co-occurring alterations that may cause resistance to MET inhibitors; the study also identified 6 different subclasses of METex14 skipping alterations based on their location, illustrating the complexity of this cancer, which has a poor prognosis
Genocea Biosciences Inc., of Cambridge, Mass. GEN-009 Neoantigen vaccine Cancer An analysis of an ongoing phase I/IIa trial showed 7 out of 8 patients enrolled have continued without progression with a median follow-up of more than 1 year; all patients received dosing as planned, with 5 doses given over a 6-month period with immune responses occurring rapidly after only 2 vaccinations; no significant adverse side effects were reported, with only mild symptoms associated with the vaccine adjuvant
Gilead Sciences Inc., of Foster City, Calif. Magrolimab Monoclonal antibody against CD47 Previously untreated myelodysplastic syndrome and acute myeloid leukemia Updated results from a phase Ib trial of magrolimab in combination with azacitidine showed that, of 33 MDS patients who were evaluable for efficacy, 91% achieved an objective response, including 42% with a complete response (CR); responses to magrolimab and azacitidine deepened over time, and the CR rate with at least 6 months of follow-up was 56% in MDS patients; in AML, 64% of patients evaluable for efficacy achieved an objective response, including 56% with a CR or a CR with incomplete blood count recovery (CRi); in TP53-mutant AML, 75% achieved a CR or CRi
Gilead Sciences Inc., of Foster City, Calif., and subsidiary Kite Pharma Yescarta (axicabtagene ciloleucel) CAR T therapy targeting CD19 Relapsed or refractory indolent non-Hodgkin lymphoma Results from an interim analysis of the phase II Zuma-5 study showed after a single infusion of Yescarta, 93% of patients responded, with 80% achieving a complete response
Gossamer Bio Inc., of San Diego GB-1275  Oral CD11b modulator  Solid tumors Early safety and biomarker data from a phase I/II study show it has been well-tolerated to date, both as monotherapy and in combination with Keytruda; no dose-limiting toxicities have been reported, and dose escalation in both arms continues; dose-dependent increases in GB-1275 plasma concentration have been observed, and the 7-hour elimination half-life of GB-1275 supports twice-daily dosing
Harpoon Therapeutics Inc., of South San Francisco HPN-424 Tri-specific T-cell activating construct targeting PSMA Progressive, metastatic castration-resistant prostate cancer Initial safety data from the phase I trial showed it is generally well-tolerated, and cytokine-related adverse events have been transient and manageable; pharmacokinetic data support weekly dosing and pharmacodynamic data support T-cell activation as measured by reduction in circulating tumor cells, increased serum cytokine levels and T-cell margination after HPN424 administration; early signals of clinical activity include 8 patients who remained on study treatment for greater than 24 weeks, and 8 patients exhibited decreases in PSA levels compared to baseline, including 2 who showed PSA reductions of at least 50%
Heat Biologics Inc., of Durham, N.C. HS-110 Allogeneic cell-based therapy Advanced non-small-cell lung cancer Phase II data for HS-110 in combination with Opdivo (nivolumab) demonstrated significant survival benefit in a cohort of previously treated, checkpoint inhibitor-naïve patients with advanced NSCLC; median overall survival (mOS) was 28.7 months for the intent-to-treat patients; a statistically significant survival benefit with mOS of 42.1 months was observed in patients with injection site reaction (p=0.0001)
Immunogen Inc., of Waltham, Mass. Mirvetuximab soravtansine Antibody-drug conjugate Ovarian cancer Data from phase Ib/II Forward II study in combination with Avastin (bevacizumab, Roche Holding AG) in patients with medium and high folate receptor alpha-expressing recurrent disease for whom non-platinum-based combination regimen is appropriate showed objective responses in 28 patients and confirmed overall response rate of 47% in overall population; in patients with high FRalpha expression, confirmed ORR was 64%, with ORR of 59% in platinum-resistant subgroup
Iovance Biotherapeutics Inc., of San Carlos, Calif. Lifileucel Tumor infiltrating lymphocyte therapy Advanced melanoma Long-term interim data from cohort 2 of C-144-01 study showed median duration of response has not been reached at 18.7 months of study follow-up; as of April 23, 2020, cutoff, treatment showed 36.4% overall response rate (2 complete responses and 22 partial responses) and disease control rate of 80%
IMV Inc., of Dartmouth, Nova Scotia DPX-Survivac Targeted immunotherapy Ovarian cancer Data from phase II Decide1 study in combination with intermittent low-dose cyclophosphamide in patients with recurrent, advanced platinum-sensitive and resistant disease showed 5 of 19 patients (26%) achieved partial response with tumor regression >30% on target lesions; 15 of 19 (79%) achieved disease control, defined as stable disease or partial response on target lesions; tumor shrinkage of target lesions was observed in 10 patients (53%)
Incyte Corp., of Wilmington, Del. Iclusig (ponatinib) Targets Bcr-Abl Chronic myeloid leukemia Interim analysis from phase II Optic trial show, with median follow-up time of about 21 months, 77% of patients were evaluable for primary endpoint; benefit seen in all 3 starting doses; maximum rates of ≤1% Bcr-Abl1IS at 12 months achieved in 45-mg/day starting dose cohort (38.7%), and responses were maintained with the dose reduction to 15 mg/day; with protocol-mandated dose reduction for response in higher-dose cohorts, 75% patients in 45-mg cohort and 88% patients in 30-mg cohort were able to maintain ≤1% Bcr-Abl1IS response for as long as up to 2 years
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) Oral Selective Inhibitor of Nuclear Export compound Multiple myeloma Results from pivotal phase III Boston study testing combination with once-weekly Velcade (bortezomib) and low-dose dexamethasone (SVd) vs. twice-weekly Velcade plus low-dose dexamethasone (Vd) in patients who have received 1 to 3 prior lines of therapy showed 47% increase in median progression-free survival for SVd group vs. Vd group (median PFS of 13.93 months vs. 9.46 months, p=0.0075); SVd group also demonstrated significantly greater overall response rate compared to Vd group (76.4% vs. 62.3%, p=0.0012), as well as higher rate of deep responses (44.6% vs. 32.4%) as well as longer median duration of response (20.3 months vs. 12.9 months); 16.9% on SVd arm achieved complete response or stringent complete response vs. 10.6% on Vd 
Kiadis Pharma NV, of Amsterdam FC21-NK NK-cell adoptive immunotherapy Acute myeloid leukemia  In subgroup of patients with concurrent CNS disease, showed all 4 patients completed ≥6 FC21-NK infusions and showed a response that lasted up to 5.5 months; CNS responses as indicated by resolution or cellular infiltration of CNS lesions observed in all 4 patients; 2 experienced complete resolution of CNS lesions, 1 had a near complete response and 1 achieved a 50% reduction of CNS chloromas
Kiadis Pharma NV, of Amsterdam FC21-NK NK-cell adoptive immunotherapy Multiple myeloma Preclinical data show CD38 knockout NK cell therapy has the potential to maximize the efficacy of daratumumab by limiting NK cell fratricide and enhancing overall activity against MM cells in presence of anti-CD38 antibody
Kiadis Pharma NV, of Amsterdam FC21-NK NK-cell adoptive immunotherapy Relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes Phase I trial described to establish safety of OTS FC21-NK cells for the induction of remission in patients with R/R AML and MDS; enrollment of study has started, with aim to include up to 56 patients in dose-determination and expansion phase
Kura Oncology Inc., of San Diego Tipifarnib Inhibitor of farnesyl transferase HRAS-mutant head and neck squamous cell carcinoma Updated data from phase II Run-HN study in patients whose disease progressed after prior therapy showed 9 of 18 evaluable patients achieved confirmed partial response, for an objective response rate of 50%, with median duration of response of 14.7 months; median progression-free survival was 5.9 months, compared to 2.8 months on the patients’ last prior therapy; median overall survival was 15.4 months 
Marker Therapeutics Inc., of Houston MultiTAA-specific T-cell therapy T-cell-based immunotherapy Advanced or metastatic pancreatic adenocarcinoma Updated phase I data showed combination with standard chemotherapy resulted in 4 of 13 evaluable patients experiencing objective responses, with 1 experiencing radiographic complete response occurring at month 9 after starting chemo and 3 experiencing partial responses per RECIST occurring at 6-9 months after starting chemo; 6 patients had stable disease; 1 patient experienced mixed response and 2 had disease progression
Merck & Co. Inc., of Kenilworth, N.J., and Eisai Co. Inc., of Woodcliff Lake, N.J. Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Anti-PD-1 monoclonal antibody plus multikinase inhibitor Unresectable hepatocellular carcinoma and metastatic clear cell renal cell carcinoma Data from Keynote-524 and Keynote-146 studies showed clinically meaningful objective response rates in HCC patients with no prior systemic therapy and in ccRCC patients who progressed following immune checkpoint inhibitor therapy
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 monoclonal antibody Microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer Data from phase III Keynote-177 trial in first-line patients, monotherapy significantly reduced risk of disease progression or death by 40% (p=0.0002) and showed median progression-free survival of 16.5 months vs. 8.2 months for patients on chemotherapy (investigator’s choice of mFOLFOX6 or FOLFIRI, with or without bevacizumab or cetuximab)
Nextcure Inc., of Beltsville, Md. NC-318 Immunomedicine against S15 Tumors Early biomarker data from phase I portion of phase I/II monotherapy trial suggest potential of drug to block S15-mediated immune suppression, as indicated by increase of regulatory T cells in peripheral blood in highest dose cohorts, increase of PD-1 expression on circulating CD4+ T cells, expansion of peripheral T-cell receptor clones, and presence of proliferating CD8 T cells systemically and increase of proliferating lymphocytes within the tumor microenvironment while on treatment
Novartis AG, of Basel, Switzerland Tafinlar (dabrafenib) and Mekinist (trametinib) BRAF inhibitor and MEK1/2 inhibitor Melanoma Updated results from Combi-AD trial testing treatment following surgical removal in BRAF-mutation-positive disease showed 52% of patients treated with combo were alive and relapse-free at 5 years vs. 36% in placebo arm; median relapse-free survival not yet reached at 5-year data cutoff for combo treatment vs. 16.6 months for placebo; combo reduced risk of relapse or death by 49% vs. placebo
Oncolytics Biotech Inc., of San Diego Pelareorep Immuno-oncolytic virus therapy Multiple myeloma Phase Ib data in carfilzomib-refractory patients treated with combination with carfilzomib showed combo results in selective replication of pelareorep in cancer cells and beneficial induction of an inflamed tumor environment associated with clinical responses; when combined with carfilzomib, pelareorep activates inflammatory response accompanied by a 50% overall response rate and 83% clinical benefit rate; 3 partial responses, 1 minimal response, 1 stable disease and 1 progressive disease achieved among patients
Pfizer Inc., of New York, and Astellas Pharma Inc., of Tokyo Xtandi (enzalutamide) Androgen receptor antagonist Non-metastatic castration-resistant prostate cancer Final results from phase III Prosper study in combination with androgen deprivation therapy (ADT) showed reduction in risk of death by 27% vs. placebo plus ADT (p=0.001); median overall survival was 67 months vs. 56.3 months
Rapt Therapeutics Inc., of South San Francisco FLX-475 Small-molecule CCR4 antagonist Multiple tumor types Phase I/II data showed a pharmacodynamic assay measuring receptor occupancy on circulating regulatory T cells demonstrated the drug achieved exposure levels over the targeted 75%, predicting maximal inhibition of regulatory T-cell recruitment into tumors via CCR4 signaling; levels of FLX-475 increased in a dose-proportional manner, with a strong PK/PD correlation observed between drug levels and receptor occupancy
Rgenix Inc., of New York RGX-202 Small-molecule inhibitor of SLC6a8/CKB pathway Advanced gastrointestinal solid tumors Data from 10 evaluable patients showed, among 5 with KRAS-mutated colorectal cancer, 1 achieved partial response and 2 achieved stable disease, for an overall response rate of 20% and disease control rate (DCR) of 60%; ORR in all evaluable CRC patients, regardless of KRAS status, was 10% with a DCR of 40%
Roche Holding AG, of Basel, Switzerland Alecensa (alectinib) Tyrosine kinase inhibitor targeting ALK ALK-positive non-small-cell lung cancer Updated data from pivotal phase III Alex study showed increased 5-year survival rate vs. crizotinib (62.5% vs. 45.5%); overall survival data, which are not yet mature, show benefit in patients with CNS metastases at baseline (42% reduction in risk of death vs. crizotinib) as well as in those without CNS metastases at baseline (24% reduction in risk of death vs. crizotinib)
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Libtayo (cemiplimab-rwlc) PD-1 inhibitor Advanced cutaneous squamous cell carcinoma Longer-term data from pivotal phase II study show both longer durability and higher complete response (CR) rates than previously reported; with up to 3 years of follow-up, 46% of patients experienced tumor shrinkage, with a median time to response of 2 months; more patients (16%) saw tumors disappear completely over time compared to previous analyses; among patients with metastatic disease who had longest follow-up, 20% have now achieved complete response, increasing from 7% in 2017 primary analysis
Seattle Genetics Inc., of Bothell, Wash. Tukysa (tucatinib) HER2 inhibitor HER2-positive metastatic breast cancer Results from exploratory analyses of intracranial efficacy, including survival, in patients who had stable or active brain metastases in HER2Climb pivotal trial showed addition of tucatinib to trastuzumab and capecitabine delayed progression in the brain (62% reduction in risk of CNS disease progression), doubled the intracranial response rate (47% vs. 20%) and reduced overall risk of death by 42%
Silverback Therapeutics Inc., of Seattle SBT-6050 ImmunoTAC candidate Tumors Preclinical data showed drug activates human myeloid cells in a HER2-dependent manner in vitro, and that SBT-6050 mouse surrogate exhibits potent antitumor efficacy as single agent and in combination with trastuzumab in vivo
Syros Pharmaceuticals Inc., of Cambridge, Mass. SY-5609 Oral inhibitor of CDK7 Colorectal cancer Preclinical data show drug inhibits tumor growth, including inducing sustained regressions, at well-tolerated doses in colorectal cancer models, supporting the inclusion of colorectal cancer patients in ongoing phase I trial
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Pevonedistat NEDD8-activating enzyme inhibitor Rare leukemias, including higher-risk myelodysplastic syndromes Data from phase II trial testing combination with azacitidine vs. azacitidine alone show median overall survival was 21.8 months for combo arm vs. 19 months for azacitidine alone (p=0.334); event-free survival (EFS) was 21 months vs. 16.6 months; in higher-risk MDS subgroup, median OS was 23.9 months vs. 19.1 months for azacitidine alone and median EFS was 20.2 months vs. 14.8 months; in low-blast acute myeloid leukemia subgroup, median OS was 23.6 months vs. 16 months
TG Therapeutics Inc., of New York Ublituximab Glycoengineered anti-CD20 monoclonal antibody High-risk chronic lymphocytic leukemia Final results from phase III Genuine study testing combination with ibrutinib vs. ibrutinib alone in previously treated patients showed addition of ublituximab improved overall response rate (93% vs. 78%, p=0.019), complete response/complete response with incomplete blood count recovery rate (20% vs. 5%, p=0.024), and increased rates of undetectable minimal residual disease rate (46% vs. 7%, p<0.001) in patients with relapsed/refractory CLL with high-risk cytogenetics
Tolero Pharmaceuticals Inc., of Salt Lake City TP-1287 CDK9 inhibitor  Advanced solid tumors Preliminary phase I findings showed 44% of evaluable patients remained on treatment for more than 4 cycles; 48% of evaluable patients experienced a best response of stable disease, and 1 experienced partial response; dose of 8 mg twice daily showed proof of mechanism by reducing levels of phosphorylated RNA polymerase II, a downstream target of CDK9
Tolero Pharmaceuticals Inc., of Salt Lake City TP-3654 PIM kinase inhibitor Advanced solid tumors Phase I data showed 33% of response evaluable patients (3 of 9) experienced stable disease for more than 16 weeks; 67% (6 of 9) experience best response of stable disease; patients administered TP-3654 had a reduction of BAD phosphorylation, a pro-survival downstream effector of PIM kinase activation
Trillium Therapeutics Inc., of Cambridge, Mass. TTI-622 Targets CD47 Advanced relapsed or refractory lymphoma Data from ongoing dose-escalation phase I study indicate dose-dependent increases in both drug exposure and target engagement, with receptor occupancy levels above 60% at doses of 2 mg/kg measured immediately after and 24 hours after infusion administration; objective responses observed in 2 heavily pretreated diffuse large B-cell lymphoma patients
Ziopharm Oncology Inc., of Boston Controlled IL-12, Ad-RTS-hIL-12 plus veledimex Targets IL-12 Recurrent glioblastoma Phase I data showed Ad+V was safely administered and tolerable in both craniotomy (group 1, n=31) and stereotactic subjects (group 2, n=7); subjects who received low-dose (≤ 20 mg cumulative) corticosteroids during veledimex dosing (days 0 to 14, coinciding with administration of veledimex) had median overall survival (mOS) of 17.8 months (mean follow-up of 18.4 months); 15 subjects treated with Ad (day 0) and 20-mg veledimex with any dosing of corticosteroids had a mOS of 12.7 months (mean follow-up of 13.1 months)


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