- |||||||||| oleclumab (MEDI9447) / AstraZeneca, monalizumab (IPH2201) / AstraZeneca, Innate, Imfinzi (durvalumab) / AstraZeneca
Updated results from COAST, a phase 2 study of durvalumab (D) (Hall A; Poster Bd #: 308) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3305; P2, P3 Safety was similar across arms, with no new safety signals. Further investigation of D, D+O, and D+M in this population is ongoing in the Phase 3 PACIFIC-9 study (NCT05221840).
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy, Metastases: BEGONIA: A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Apr 23, 2024 P1/2, N=240, Recruiting, Further investigation of D, D+O, and D+M in this population is ongoing in the Phase 3 PACIFIC-9 study (NCT05221840). Trial completion date: Aug 2024 --> Nov 2024 | Trial primary completion date: Aug 2024 --> Nov 2024
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed, Trial completion date, Trial primary completion date: Neo-CheckRay: Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer: (clinicaltrials.gov) - Mar 15, 2024 P2, N=147, Active, not recruiting, Durvalumab-ceralasertib is under further investigation in immunotherapy-refractory NSCLC.ClinicalTrials.gov identifier: NCT03334617. Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Sep 2029 | Trial primary completion date: Jan 2024 --> Sep 2024
- |||||||||| oleclumab (MEDI9447) / AstraZeneca
PK/PD data, Preclinical, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: Efficacy and pharmacodynamic effect of anti-CD73 and anti-PD-L1 monoclonal antibodies in combination with cytotoxic therapy: observations from mouse tumor models. (Pubmed Central) - Jan 11, 2024 Using a murine monoclonal antibody surrogate of Oleclumab, we investigated the effect of CD73 inhibition in concert with cytotoxic therapies (chemotherapies as well as fractionated radiotherapy) and PD-L1 blockade...This therapeutic outcome was in part driven by cytotoxic CD8 T-cells, as evidenced by the detrimental effect of CD8 depleting antibody treatment of MCA205 tumor bearing mice treated with anti-CD73, anti-PD-L1 and 5-Fluorouracil+Oxaliplatin (5FU+OHP)...Inclusion of comparator groups representing the various components of the combination allowed deconvolution of contribution of the individual therapeutic elements; highlighting specific effects mediated by the anti-CD73 antibody with respect to immune-cell representation, chemotaxis and myeloid biology. These pre-clinical data reflect complementarity of adenosine blockade with cytotoxic therapy, and T-cell checkpoint inhibition, and provides new mechanistic insights in support of combination therapy.
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, monalizumab (IPH2201) / AstraZeneca, Innate, Imfinzi (durvalumab) / AstraZeneca
Enrollment open, Metastases: Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), The ARCHON-1 Trial (clinicaltrials.gov) - Jan 11, 2024 P1, N=48, Recruiting, These pre-clinical data reflect complementarity of adenosine blockade with cytotoxic therapy, and T-cell checkpoint inhibition, and provides new mechanistic insights in support of combination therapy. Suspended --> Recruiting
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment open: DORA: Durvalumab and Oleclumab in Resectable PDAC (clinicaltrials.gov) - Jan 7, 2024 P2, N=22, Recruiting, Suspended --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Phase classification, Trial termination, Combination therapy, Metastases: COLUMBIA 1: COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC (clinicaltrials.gov) - Nov 15, 2023 P1/2, N=61, Terminated, This novel treatment combination was considered safe and is worth further investigation in a randomized phase II trial. Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; On 17 February 2022, the decision was made to terminate the clinical study because superior efficacy was not observed for the novel study drug combinations under investigation.
- |||||||||| Trial completion date, Trial primary completion date, IO biomarker: NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov) - Oct 31, 2023
P2, N=350, Recruiting, Multiplatform immune profiling suggested improved MPR rates in the durvalumab plus oleclumab and durvalumab plus monalizumab arms were associated with enhanced effector immune infiltration of tumors, interferon responses and markers of tertiary lymphoid structure formation, and systemic functional immune-cell activation. Trial completion date: Mar 2026 --> Dec 2028 | Trial primary completion date: Mar 2026 --> Dec 2028
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Surgery: Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer (clinicaltrials.gov) - Oct 30, 2023 P2, N=30, Recruiting, Trial completion date: Mar 2026 --> Dec 2028 | Trial primary completion date: Mar 2026 --> Dec 2028 Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap
GI-108, a novel bispecific fusion protein augments anti-tumor immunity by alleviating immunosuppressive adenosine pathway in CD8+ T cells (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1377; Compared to Oleclumab, GI-108 demonstrated superior maximum efficacy in blocking both membrane-bound and soluble CD73 without inducing any hook effects...Importantly, the phosphorylation of STAT5 in CD8+ T cells by GI-108 was greater than that by wild-type IL-2, Proleukin...Conclusions GI-108 is a potent bifunctional fusion protein with the ability to selectively target to the tumor site to reinvigorate immunosuppressed immune cells in the TME. As such, this innovative IL-2-based bifunctional agent provides a promising therapeutic strategy for the treatment of cancer.
- |||||||||| oleclumab (MEDI9447) / AstraZeneca
Journal: A Novel Bispecific Antibody for EpCAM-Directed Inhibition of the CD73/Adenosine Immune Checkpoint in Ovarian Cancer. (Pubmed Central) - Jul 29, 2023 Thus far, conventional CD73-blocking antibodies such as oleclumab show limited clinical efficacy, probably due to the fact that it indiscriminately binds to and blocks CD73 on a massive surplus of normal cells...Additionally, treatment with bsAb CD73xEpCAM potently inhibited the proliferative capacity of OC cells and enhanced their sensitivity to cisplatin, doxorubicin, 5FU, and ionizing radiation. BsAb CD73xEpCAM may be useful in the development of tumor-directed immunotherapeutic approaches to overcome the CD73-mediated immunosuppression in patients with refractory OC.
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion, Trial completion date, Combination therapy, Metastases: D6070C00001: MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors. (clinicaltrials.gov) - Jul 12, 2023 P1, N=192, Completed, BsAb CD73xEpCAM may be useful in the development of tumor-directed immunotherapeutic approaches to overcome the CD73-mediated immunosuppression in patients with refractory OC. Trial completion date: Jun 2023 --> Mar 2023 | Active, not recruiting --> Completed
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, IO biomarker, Metastases: SYNERGY: Paclitaxel + Carboplatin + Durvalumab With or Without Oleclumab for Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC (clinicaltrials.gov) - Jun 15, 2023 P1/2, N=129, Active, not recruiting, Active, not recruiting --> Recruiting Trial completion date: Oct 2023 --> Apr 2025 | Trial primary completion date: Jul 2023 --> Aug 2024
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Enrollment change, Trial completion date, Trial primary completion date, Metastases: MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - Jun 1, 2023 P1, N=175, Active, not recruiting, Trial completion date: Oct 2023 --> Apr 2025 | Trial primary completion date: Jul 2023 --> Aug 2024 N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023
- |||||||||| imaradenant (AZD4635) / AstraZeneca
Trial completion, Trial completion date: An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer (clinicaltrials.gov) - May 31, 2023 P2, N=59, Completed, N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023 Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Apr 2023
- |||||||||| imaradenant (AZD4635) / AstraZeneca
Trial completion, Trial completion date, Monotherapy, Metastases: A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - May 26, 2023 P1, N=313, Completed, Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Apr 2023 Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Mar 2023
- |||||||||| MODULE 1: Incorporation of Immunotherapeutic Strategies into the Management of Nonmetastatic Non-Small Cell Lung Cancer (NSCLC) (Hilton Chicago, Grand Ballroom ) - May 15, 2023 - Abstract #ASCO2023ASCO_7037;
This event is organized and accredited by Research to Practice and supported through educational grants provided by AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Lilly, Novocure Inc, Regeneron Pharmaceuticals Inc, and Takeda Pharmaceuticals USA Inc. Key findings from the Phase III CheckMate 816 trial evaluating nivolumab in combination with chemotherapy as neoadjuvant therapy for patients with resectable Stage IB to IIIA NSCLC Recent FDA approval of neoadjuvant nivolumab; selection of patients for this therapy Recently presented data from the Phase III AEGEAN study of neoadjuvant durvalumab and chemotherapy followed by adjuvant durvalumab for patients with resectable NSCLC Emerging findings from the Phase III KEYNOTE-671 study of pembrolizumab/platinum-based chemotherapy followed by resection and pembrolizumab for localized NSCLC Published findings from the Phase III IMpower010 trial evaluating atezolizumab versus best supportive care after adjuvant chemotherapy for patients with completely resected NSCLC; impact of PD-L1 status on outcomes Key efficacy and safety data from the Phase III PEARLS/KEYNOTE-091 study of pembrolizumab as adjuvant therapy for Stage IB to IIIA NSCLC FDA approval of atezolizumab and pembrolizumab as adjuvant therapy; current clinical roles Long-term efficacy and safety findings, including 5-year overall survival data, from the Phase III PACIFIC trial evaluating consolidation durvalumab after chemoradiation therapy for patients with unresectable Stage III NSCLC
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy, Metastases: BEGONIA: A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - May 1, 2023 P1/2, N=240, Active, not recruiting, Key findings from the Phase III CheckMate 816 trial evaluating nivolumab in combination with chemotherapy as neoadjuvant therapy for patients with resectable Stage IB to IIIA NSCLC Recent FDA approval of neoadjuvant nivolumab; selection of patients for this therapy Recently presented data from the Phase III AEGEAN study of neoadjuvant durvalumab and chemotherapy followed by adjuvant durvalumab for patients with resectable NSCLC Emerging findings from the Phase III KEYNOTE-671 study of pembrolizumab/platinum-based chemotherapy followed by resection and pembrolizumab for localized NSCLC Published findings from the Phase III IMpower010 trial evaluating atezolizumab versus best supportive care after adjuvant chemotherapy for patients with completely resected NSCLC; impact of PD-L1 status on outcomes Key efficacy and safety data from the Phase III PEARLS/KEYNOTE-091 study of pembrolizumab as adjuvant therapy for Stage IB to IIIA NSCLC FDA approval of atezolizumab and pembrolizumab as adjuvant therapy; current clinical roles Long-term efficacy and safety findings, including 5-year overall survival data, from the Phase III PACIFIC trial evaluating consolidation durvalumab after chemoradiation therapy for patients with unresectable Stage III NSCLC Trial completion date: Jun 2023 --> Aug 2024 | Trial primary completion date: Jun 2023 --> Aug 2024
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Safety and clinical activity of oleclumab (O) (Available On Demand; Poster Bd # 457) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1262; P1b/2 Clinical trial information: NCT03611556. >
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, ATG-037 / Antengene
Targeting CD73-adenosine axis for the treatment of multiple myeloma (Section 17; Poster Board #27) - Mar 14, 2023 - Abstract #AACR2023AACR_2555; The murine myeloma cells were implanted subcutaneously into BALB/c mice, and ATG-037 (100 mg/kg) or vehicle was orally administered BID starting day one post-implantation. ATG-037 demonstrated complete inhibition of CD73 activity without
- |||||||||| oleclumab (MEDI9447) / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: COLUMBIA 1: COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC (clinicaltrials.gov) - Mar 13, 2023 P1b/2, N=61, Completed, ATG-037 demonstrated complete inhibition of CD73 activity without Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Oct 2022 | Trial primary completion date: Oct 2023 --> Oct 2022
|