The annual ESMO conference is among the most prestigious and influential global oncology conferences, during which oncologists around the world share the latest research progress in cancer treatments. The ESMO conference presents a well-reputed platform for pharmaceutical companies to showcase the efficacy and safety of their assets in the oncology portfolio.
There is excitement around front-line gastric cancer and triple-negative breast cancer results. There is also a fair amount of curiosity around the results of few unexpected failed trials like Novartis’ Combi-I in melanoma, Roche’s IMpasssion-131 in TNBC, and Merck’s Keynote-361 in urothelial cancer.
DelveInsight lists a few assets by tumor whose results we look forward to:
Breast Cancer
Atezolizumab
IMpassion131- Phase III IMpassion131 study evaluated Roche’s asset Tecentriq (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel in Late breaking abstract (LBA1). It failed to meet the primary endpoint of progression-free survival (PFS) for the initial treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population.
IMpassion130- evaluated atezolizumab in combination with nab-paclitaxel. Investigators have reported a statistically significant PFS benefit and, while not formally tested, showed clinically meaningful improvements in OS for people with metastatic TNBC whose tumors express PD-L1 (≥1%).
IMpassion031- Phase III study is evaluating atezolizumab in combination with chemotherapy nab-paclitaxel; followed by doxorubicin and cyclophosphamide in comparison to placebo plus chemotherapy. The drug met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.
- HER2+ with Brain Metastases
Tucatinib:- Seattle Genetics will present the results for Tucatinib, which was recently approved for the treatment of metastatic breast cancer. The drug is associated with overall survival (OS) benefit in patients with active brain metastases, according to an exploratory subgroup analysis of the HER2CLIMB trial (Abstract: #2067, Abstract: #275O, Abstract: #2073, Abstract: #293P)
Ipatasertib:-Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with PTEN loss tumors.
Palbociclib:- Pfizer plans to present the results of PALLAS which is a randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer(Presentation LBA12).
Abemaciclib:- Lilly & Co. plans to present the results of nextMONARCH which includes the final overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with HR+, HER2- metastatic breast cancer(Abstract 273O).
Nivolumab:- Bristol Myers Squibb will present the data for the first time for Phase 3 CheckMate -649. The trial evaluates the overall survival and progression-free survival results for Opdivo plus chemotherapy compared with chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma (Abstract: #LBA6).
Lenvatinib:- Merck will present for the first-time data from the Phase 2 LEAP-005 study evaluating KEYTRUDA plus LENVIMA in six new tumor types including biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, and triple-negative breast cancer(Abstract #LBA41).
Trastuzumab deruxtecan:- AstraZeneca will present the exploratory data from the DESTINY-Gastric01 Phase II trial. They will show the results of Enhertu (trastuzumab deruxtecan) in patients with metastatic gastric cancer and low expression of HER2 (Abstract #1422MO).
Vibostolimab + Pembrolizumab:- Merck will present the data for the first-time from a cohort expansion phase of a Phase 1b study evaluating vibostolimab in combination with KEYTRUDA in patients with anti-PD-1/PD-L1-naïve advanced NSCLC and also the data for the first time from a cohort expansion phase of a Phase 1b study evaluating vibostolimab as monotherapy and in combination with KEYTRUDA in patients with anti-PD-1/PD-L1 refractory NSCLC (Abstract #1410P, Abstract #1400P).
Lorlatinib:- Pfizer will present the result of the Phase 3 CROWN study which evaluated the Lorlatinib vs Crizotinib in the First-line Treatment of Patients with advanced ALK-positive Non-Small Cell Lung Cancer (NSCLC) (Presentation LBA2).
Spartalizumab:-Novartis will present data for spartalizumab in combination with dabrafenib and trametinib among untreated patients with stage IIIC or stage IV BRAFV600 mutation-positive cutaneous melanoma in failed COMBI-I trial (Abstract #LBA43).
Pembrolizumab:- Merck will present the results for the first time the results of distant metastasis-free survival data from the Phase 3 KEYNOTE-054 trial evaluating KEYTRUDA patients with high-risk Stage 3 melanoma following complete resection (Abstract #LBA46).
Lenvatinib:- Merck will present the results for the first time the data from the Phase 2 LEAP-004 study evaluating KEYTRUDA plus LENVIMA for the second-line treatment of patients with melanoma who progressed on anti-PD-1/PD-L1 therapy (Abstract #LBA44).
Nivolumab:- Bristol Myers Squibb will present the four-year results from CheckMate -238 evaluating Opdivo versus Yervoy in adjuvant melanoma and five-year characterizations of complete responses from CheckMate -066, CheckMate -067, and CheckMate -069 studies evaluating Opdivo plus Yervoy or Opdivo alone in advanced melanoma (Abstract: #1076O, Abstract: #1105P).
Tisotumab Vedotin:- Seattle Genetics will present the data for innovaTV 208: New Weekly Dosing Cohort in the Phase 2 Study of Tisotumab Vedotin in Platinum-Resistant Ovarian Cancer (Abstract: #2221).
Olaparib:- Merck will present the new five-year recurrence-free survival data from the Phase 3 SOLO-1 trial evaluating maintenance LYNPARZA in patients with newly diagnosed, advanced BRCA-mutated ovarian cancer. Merck will also present the data for SOLO2/ENGOT Ov-21 Trial. It evaluated the Efficacy of subsequent chemotherapy for patients With BRCA1/2 mutated platinum-sensitive recurrent epithelial ovarian cancer (EOC) progressing on Olaparib vs placebo (Abstract: #811MO, Abstract: #813MO).
Olaparib:- Merck will present the result of Olaparib + Bevacizumab (Bev) in patients (Pts) with newly diagnosed advanced high-grade ovarian cancer (HGOC): RECIST and/or CA-125 objective response rate (ORR) in the Phase III PAOLA-1. It will also present the result for Olaparib Plus Bevacizumab (Bev) in Patients (Pts) with newly diagnosed advanced high-grade ovarian carcinoma (HGOC): final analysis of second progression-free survival (PFS2) in the Phase III PAOLA-1/ENGOT-ov25 trial (Abstract: #812MO, Abstract: #LBA33).
Niraparib:- Zai Lab will present the results for an individualized starting dose of Niraparib in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC): a randomized, double-blind, placebo-controlled, Phase 3 trial (NORA) (Abstract: #LBA29).
Pamiparib:- Biegene will present the results for clinical benefit in biomarker-positive patients (pts) with locally advanced or metastatic solid tumors treated with the PARP1/2 inhibitor Pamiparib in combination with low-dose (LD) Temozolomide (TMZ) (Abstract: #820P).
Olaparib + durvalumab + bevacizumab:- AstraZeneca will present the results for Phase II trial of Lynparza plus Imfinzi and bevacizumab (MEDIOLA): initial results in patients with non-germline BRCA-mutated platinum-sensitive relapsed ovarian cancer (Abstract #814MO).
Other GI Tract Tumours
Pembrolizumab:- Merck will present the Phase 3 KEYNOTE-177 data on health-related quality of life (HRQoL) in patients (Pts) treated with Pembrolizumab (Pembro) vs chemotherapy as first-line treatment in microsatellite instability-high (MSI-H) and/or deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) (Abstract #396O).
Olaptesed+Pembrolizumab:- Noxxon Pharma will present the data for Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer.
Pembrolizumab:- Merck will present for the first time the data from the Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal cancer (Abstract #LBA8).
Nivolumab:- Bristol-Myers Squibb will present the data for the first time for Phase 3 CheckMate -577. The study evaluates the disease-free survival results for adjuvant Opdivo versus placebo for patients with resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy (Abstract: #LBA9).
Ripretinib:- Deciphera Pharma will present the analyses from INVICTUS for the efficacy and safety of ripretinib as ≥4th-line therapy for patients with gastrointestinal stromal tumors (GIST) following crossover from placebo.
Urothelial cancer
Nivolumab + ipilimumab:- Bristol Myers Squibb will present the results of Nivolumab (N) alone or in combination with ipilimumab (I) in patients (pts) with platinum-pretreated metastatic urothelial carcinoma (mUC): extended follow-up from CheckMate 032 (Abstract: #749P).
Durvalumab + tremelimumab:- AstraZeneca will present the results for the DANUBE Phase III trial will be presented in an oral presentation showing the results for Imfinzi with and without tremelimumab in patients with advanced bladder cancer, including analyses of patients with high PD-L1 expression. The trial did not meet its primary endpoints (Abstract #697O).
Enfortumab vedotin:-Seattle genetics will present the long-term results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and PD-1/PD-L1 inhibitors (#2223/#746P).
Tisotumab Vedotin:- Seattle Genetics will present the results of Phase 2 innovaTV 204 trial. It will be presented as a late-breaking oral presentation. The company will present the positive results evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer (Abstract: #3435).
Balstilimab + Zalifrelimab:- Agenus Bio will present the data for RaPiDS which is a two Phase 2 trials of balstilimab +/- zalifrelimab in patients with refractory cervical cancer as part of a late-breaking abstract and will be presented as an oral presentation.
Avelumab:-Pfizer plans to present the results of Avelumab First-line (1L) maintenance + best supportive care (BSC) vs BSC Alone with 1L Chemotherapy (CTx) for advanced urothelial carcinoma (UC): subgroup analyses from JAVELIN bladder 100 (Presentation 704MO).
Sintilimab:- Eli Lilly and Innovent will present the results of Sintilimab plus IBI305 (bevacizumab) as the first-line treatment for advanced HCC (NCT03794440). This study will announce the safety and preliminary efficacy of combining PD-1 inhibitor and VEGF inhibitor in the first line treatment for patients with advanced unresectable or metastatic HCC (Abstract 991P).
Lenvatinib + Pembrolizumab:- Merck will present the results for KEYNOTE-146/Study 111 which is a Phase 1b/2, open-label, single-arm trial evaluating the LENVIMA plus KEYTRUDA combination in patients with selected solid tumors (Abstract #710P).
Nivolumab + cabozantinib:- Bristol Myers Squibb will for the first time present the results of Phase 3 CheckMate -9ER efficacy and safety results for Opdivo in combination with Exelixis’ CABOMETYX® (cabozantinib) versus sunitinib in previously untreated advanced renal cell carcinoma (RCC); CheckMate -9ER results will be featured as part of an ESMO Presidential Symposium and in the official press program (Abstract: #696O).
Nivolumab + ipilimumab:- Bristol Myers Squibb will for the first time present the results of Four-year follow-up from Phase 3 CheckMate -214 study of Opdivo plus Yervoy compared with sunitinib in patients with previously untreated advanced or metastatic RCC; CheckMate -214 represents the longest follow-up from a Phase 3 trial of an immunotherapy-based combination in previously untreated advanced RCC (Abstract: #711P).
Larotrectinib:- Bayer will present the results of Larotrectinib treatment of advanced TRK fusion thyroid cancer (Poster: 1916P).
Selpercatinib:- Lilly & Co. will present the data from Phase 1/2 LIBRETTO-001 trial to reinforce the benefits of Retevmo™ (selpercatinib) in the treatment of certain advanced RET-driven lung and thyroid cancers (Abstract 1922P).
Retifanlimab:- Macrogenics will present the data from POD1UM-201, the ongoing study of retifanlimab monotherapy in patients with Merkel cell carcinoma. In addition, data from POD1UM-202, the fully-enrolled, potentially registration-enabling monotherapy study in patients with squamous cell carcinoma of the anal canal, are expected to be presented at a medical congress in the second half of 2020. Retifanlimab was invented by MacroGenics and licensed to Incyte.
Pancreatic neuroendocrine tumors
Surufatinib:- Chimed will present the results of Surufatinib (S) for patients (Pts) with advanced pancreatic neuroendocrine tumors (SANET-p): a randomized, double-blind, placebo (P)-controlled Phase III trial (Abstract: #1156O).
Anti-CD19-anti-CD22 CAR T cell therapy:- Merck will present the data for Phase 1 Alexander study of AUTO3, the first CD19/22 dual targeting CAR T cell, with Pembrolizumab in patients with relapsed/refractory (R/R) DLBCL (Abstract #890MO).
