CEL-SCI Corporation, Jazz Pharmaceuticals, CARsgen and Ascentage Pharma presented clinical trial data at the American Society of Clinical Oncology 2022 Annual Meeting.
As the American Society of Clinical Oncology 2022 Annual Meeting comes to a close, several companies are presenting clinical trial data. Here’s a look at the latest ASCO news.
CEL-SCI Leukocyte Interleukin Injection
Virginia-based CEL-SCI Corporation presented an abstract and poster describing its leukocyte interleukin injection (LI) immunotherapy in advanced primary squamous cell carcinoma of the head and neck. Multikine (LI) extended overall survival (OS) in patients with treatment-naive low-risk locally advanced primary squamous cell carcinoma of the head and neck. It was from a pivotal Phase III trial.
Based on the results, the company plans to submit a Biologic License Application to the U.S. Food and Drug Administration. Additional findings suggested there was no significant difference between treatment groups in terms of safety, and in the randomized intent-to-treat population, early response decreased mortality and was predictive of overall survival.
Jazz’s Rylaze in Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Jazz Pharmaceuticals, headquartered in Dublin, announced positive data from a Phase II/III study developed and run with the Children’s Oncology Group (COG). They evaluated the intramuscular administration of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) in adult and pediatric patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who developed hypersensitivity to an E. coli-derived asparaginase.
The data confirmed the interim analysis presented in December 2021. It demonstrated that greater than 90% of patients in Cohort 1c receiving the IM dose three days per week hit nadir serum asparaginase activity (NSAA) levels greater than or equal to 0.1 IU/mL at 48 and 72 hours. The safety profile was consistent with what is seen with other asparaginases.
“We are excited to share these results from the Phase II/III trial of Rylaze highlighting the clinically meaningful nadir serum asparaginase activity from the Monday/Wednesday/Friday dosing regimen, which supports a new dosing schedule that aligns with current clinical practice,” Dr. Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz said. “Rylaze is an example of how Jazz and the Children’s Oncology Group have advanced a critically needed treatment from development through FDA approval, and then continue to explore additional dosing and administration options to address the needs of patients.”
CARsgen’s CAR-T Treatment in Solid Tumors
Shanghai, China-based CARsgen Therapeutics presented study results for CT041, an autologous CAR T-cell candidate against the Claudin18.2 protein. They presented two posters, one with data from the multicenter Phase Ib CT041 trial in the U.S. for patients with advanced gastric and pancreatic adenocarcinoma, and the second was safety and preliminary efficacy data from the Phase Ib/II CT041 trial in China for advanced gastric/gastroesophageal junction adenocarcinoma.
In the first, in a subgroup of patients, an objective response rate (ORR) of 60% was reported, with one patient achieving complete response (CR). Tumor shrinkage was seen in 80% of patients with stable disease. Median duration of response (mDOR) and progression-free survival (mPFS) was not reached.
In the second study, the preliminary data suggested CT041 had manageable safety and tolerability with promising efficacy in patients with previously treated advanced GC/GEJ.
“The updated clinical data of CT041 at ASCO 2022 are very encouraging in pre-treated CG/GEJ and PC patients, demonstrating significant efficacy and excellent tolerability, including the impressive ORR of 60% and a case of CR,” Dr. Rafaella Baffa, M.D., CARsgen’s chief medical officer said in a statement. “We look forward to the continuing development of CT041 and we believe it can help more patients.”
Ascentage’s TKI for GIST
Ascentage Pharma, based in Suzhou, China, and Rockville, Maryland., released the latest results from a Phase Ib/II trial of the third-generation tyrosine kinase inhibitor olverembatinib in patients with metastatic gastrointestinal stromal tumor (GIST) who were resistant to or failed previous TKI treatment. The drug recently received approval in China for adults with TKI-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation.
“Olverembatinib is a novel third-generation TKI with potent inhibitory activity against a range of kinases, including ABL, KIT, PDGFR, FGFR, b-RAF, DDR1, and FLT3, and has shown antitumor activity in multiple preclinical models of GIST,” Baibo Qiu, Ph.D., of Sun Yat-sen University Cancer Center and principal investigator of the study commented. “In this Phase Ib/II clinical study being conducted in China, olverembatinib has demonstrated preliminary efficacy in patients with TKI-resistant GIST, especially in the SDH-deficient subgroup.”
Targeted Cells Engaged as Portage Moves Forward with iNKT Agonist
Westport, Connecticut’s Portage Biotech presented new data Monday from a Phase I/II study of its invariant natural killer T cell (iNKT) agonist PORT-2, which is being tested for the treatment of melanoma and non-small cell lung cancer (NSCLC).
Portage CEO Dr. Ian Walters said the immuno-oncology company is “encouraged by the preliminary safety profile of PORT-2" which was well tolerated at all dose levels when administered intravenously as a monotherapy. Walters added that the therapy demonstrated single agent activity in one of the two heavily pre-treated patients at the mid-dose level.
Proof of mechanism was also achieved, with PORT-2 achieving activation of iNKT cells, NK cells and dendritic cells, Walters said. PORT-2 is also being investigated in combination with Merck’s Keytruda (pembrolizumab), and Portage anticipates sharing further data from both studies at some point later this year.
