ASCO 2018: Results Keep Rolling In


There’s plenty of news coming out of the American Society of Clinical Oncology (ASCO) Annual Meeting behind held in Chicago. Here’s a look at a few more of the top stories.

Pierre Fabre and Array BioPharma Update Phase III Melanoma Trial Data

The two companies announced results from the Phase III COLUMBUS trial in BRAF-mutant advanced melanoma. The median overall survival (mOS) was 33.6 months for patients receiving the combination of encorafenib and binimetinib compared to 16.9 months for patients receiving vemurafenib as a monotherapy. The combination also reduced the risk of death compared to vemurafenib monotherapy. The two-year OS with the combination was 58 percent.

Idera Pharmaceuticals’ ILLUMINATE-204 Trial Looks Good in Melanoma

Idera Pharma presented results from its ongoing ILLUMINATE-204 clinical trial of tilsotolimod, its intratumorally-delivered Toll-like Receptor (TLR) 9 agonist in combination with Yervoy (ipilimumab). The data showed an overall response rate (ORR) of 38 percent for the combination, including two complete responses and an ongoing partial response (PR) for 12 months. “We have clinical evidence that tilsotolimod activates both the innate and adaptive immune responses, and when used in combination with a checkpoint inhibitor like ipilimumab, triggers immune responses in previously resistant tumors,” said Adi Diab, lead trial investigator, assistant professor, Department of Melanoma Medical Oncology for University of Texas, MD Anderson Cancer Center, in a statement. “In patients with metastatic melanoma receiving premborlizumab who switched to single agent tipilimumab at the time of disease progression the reported ORR was 13 percent. The ORR was 38 percent observed in the ILLUMINATE-204 study and the duration of response, which is ongoing in most of the responders, is particularly encouraging and suggests that the combination of tilsotolimod and ipilimumab is a very promising strategy for treating patients with metastatic melanoma whose cancer does not respond to PD-1 therapy alone.”

Kyowa Kirin’s Mogamulizumab has Positive Progression Free Survival in Mycosis Fungoides

Tokyo’s Kyowa Hakko Kirin presented additional data from the pivotal MAVORIC trial. The Phase III trial evaluated mogamulizumab versus vorinostat to treat adults with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy. MF and SS are the most common subtypes of cutaneous T-cell lymphoma (CTCL). The primary endpoint was PFS, which had a clinically relevant and statistically significant increase over vorinostat.

Portola Pharmaceuticals’ SYK-JAK Inhibitor Shows Efficacy in Pre-Treated B- and T-Cell Cancers

Portola Pharma announced new interim results from its ongoing Phase IIa trial of cerdulatinib, an oral SYK/JAK inhibitor, in patients with specific subtypes of B and T-cell Non-Hodgkin Lymphoma (NHL), including relapsed/refractory follicular lymphoma (FL) and peripheral T-cell lymphoma (PTCL), and chronic lymphocytic lymphoma/small lymphocytic lymphoma (CLL/SLL). Seven of the 20 patients in the PTCL cohort had a complete response. “Cerdulatinib continues to demonstrate promising results across a wide range of B- and T-cell malignancies, including early indications of the potential for durable responses,” said Paul Hamlin, medical director for the David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, in a statement. “The new signals in relapsed/refractory PTCL and CTCL are particularly compelling when you consider the limited treatment options for patients that fail front-line therapy.”

Agios Pharmaceuticals’ Invosidenib in Early Trial in Acute Myeloid Leukemia Looks Promising

Agios Pharma presented data from a Phase I trial looking at ivosidenib (AG-120) or enasidenib (AG-221) in combination with azacitidine in newly diagnosed isocitrate dehydrogenase (IDH) mutant acute myeloid leukemia (AML). “Patients with newly diagnosed AML who are ineligible for intensive ‘7+3’ chemotherapy typically have poor outcomes and few available treatment options,” said Courtney DiNardo, lead investigator and assistant professor, department of leukemia at the University of Texas MD Anderson Cancer Center, in a statement “With additional patients now treated in the ivosidenib arm of this Phase I study, the updated combination data demonstrate a favorable safety profile and impressive response rates versus those expected with azacitidine alone. I look forward to further demonstrating the clinical benefit of utilizing an IDH inhibitor in combination with traditional frontline AML treatment as part of the ongoing Phase I and randomized trials.”

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