Baiji, Ascentage, Gracell, etc. to Announce Latest Clinical Data of Blockbuster Drugs at ASCO 2022

Gracell to Announce Latest Clinical Data of BCMA/CD19 Dual-Target CAR-T Therapy GC012F in RRMM During the 2022 ASCO Annual Meeting

On May 27, Gracell announced that it will present its B-cell maturation antigen (BCMA)/CD19 dual-target CAR-T product candidate GC012F in the form of an oral presentation at the American Society of Clinical Oncology 2022 Annual Meeting (ASCO 202

GC012F is a dual-target autologous CAR-T therapy that simultaneously targets BCMA and CD19 targets for treatme.

From October 2019 to November 2021, this single-arm, open-label, multicenter IIT study enrolled a total of 28 patients with RRMM who had received extensive prior thera.

As of the data day cutoff date of January 26, 2022, 28 patients had been evaluated for efficacy, with a median follow-up of 3 months (range: 8 - 29 months); the study is still continuing to follow up patients, to assess the depth of reli.

The safety profile of GC012F was consistent with previous observations, with predominantly low-grade cytokine release syndrome (CRS) (grade 0-2: 93%) and no grade 4 or 5 CRS; no level of immune effector cell-associated neurotoxicity (ICAN.

Seven Ascentage Pharma Clinical Studies Selected for 2022 ASCO Annual Meeting Abstracts

On May 27, Ascentage Pharma (685HK) announced that the abstracts of the company's seven clinical studies selected for the 2022 American Society of Clinical Oncology (ASCO) annual meeting have been published on the ASCO official website tod.

The seven latest clinical trials that Ascentage Pharma will present at this ASCO Annual Meeting include:

BeiGene to Present Data Reports from Eight Studies in Solid Tumor and Hematological Oncology Drug Portfolio During 2022 ASCO Annual Meeting

BeiGene announced on the 27th that it will present 8 of its rich solid tumor and hematological oncology drug portfolios at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago from June 3 to June 7, 2022 local ti.

The data highlights of this presentation include the latest clinical data of the BTK inhibitor Baiyueze® (zanubrutinib):

Long-term safety and efficacy results of the Phase 3 ASPEN clinical trial of Baiyueze® versus ibrutinib in patients with Waldenström's macroglobulinemia, with a median follow-up of 43 mont.

The primary analysis results of the Phase 2 ROSEWOOD clinical trial of Baiyueze® combined with octuzumab versus octuzumab monotherapy in patients with relapsed/refractory follicular lympho.

In addition to announcing the latest clinical trial results of Baiyueze®, BeiGene will also present its early development pipeline and Baizean® (tislelizumab) Phase 3 clinical trial RATIONALE 309 at the abstract update meeting on JuneThe results are displayed on a post.

ASPEN study: long-term follow-up results of a phase 3 randomized clinical trial of Baiyueze® versus ibrutinib in the treatment of patients with Waldenström macroglobulinemia (WM)

Abstract number: 7510

At a median follow-up of 43 months, Baiyueze® continued to demonstrate clinically meaningful efficacy and a tolerable safety profile in patients with .

Exploratory analysis showed that Baiyueze® demonstrated deeper, faster and longer-lasting remission over time than ibrutinib

The median time to complete remission or very good partial remission (CR+VGPR) was shorter in the Baiyueze® group at 7 months (range: 9-40 months), compared with ibrutinib Group was 16 months (range: 0 to 49 months)

Fewer deaths, treatment discontinuations, and dose reductions due to adverse events occurred in patients treated with Baiyueze than with ibrutinib during follow-up

The incidence of atrial fibrillation, hypertension, and bleeding was lower in the Baiyueze® group compared with ibrutinib at all time periods; patients receiving Baiyueze® experienced neutropenia Earlier, and the incidence decreased with treatment time

Baiyueze® combined with octuzumab (ZO) versus octuzumab (O) alone in the treatment of patients with relapsed/refractory (R/R) follicular lymphoma (FL): Phase 2 randomization KEY ANALYSIS RESULTS OF TRIAL ROSEWOOD

Abstract number: 7510

The ROSEWOOD trial has already met its primary endpoint - at a median follow-up of 15 months, the overall response rate (ORR) was 63% in the Pyrex® plus octuzumab arm compared to octuzumab monotherapy was 48% (p=001

Baiyueze® combined with octuzumab can bring deep and durable remission to patients, with a complete remission (CR) rate of 32%, compared with 14% in the octuzumab monotherapy group; Baiyueze The 18-month remission rate was 79% in the octuzumab plus octuzumab group and 56% in the octuzumab monotherapy group

The time until the next anti-lymphoma treatment was significantly prolonged in the Baiyueze® combined with otuzumab group after treatment (HR: 37; p=0001)

The median progression-free survival was 24 months in the Baiyueze® combined with octuzumab group compared with 12 months in the octuzumab monotherapy group (HR: 51 [95% CI, 32~ -81])

The most common toxicity of any grade and ≥3 in the Baiyueze® combined with otuzumab group was hematological toxicity, and other toxicities were similar between the two groups

Infusion-related reactions were more common in the otuzumab monotherapy group

Tianyan Pharmaceuticals to Announce Interim Data of Anti-CTLA-4 Safety Antibody ADG126 at ASCO in 2022

Tianyan Pharmaceutical announced on the 27th that it will publish the interim data of the first phase of dose escalation of the ADG126 phase Ib/II clinical trial, demonstrating the potential best-in-class safety of this anti-CTLA-4 monoclonal antibody (mA.

The abstract titled "Phase I clinical study of ADG126, an innovative masked safe antibody against CTLA-4 that achieves tumor-specific activation, potent depletion of regulatory T cells, and flexible ligand resistance in patients with advanced solid tumo.

In this dose-escalation trial of 16 patients with advanced metastatic solid tumors, about one-third of the patients had received third-line or more prior therapy, and about one-third had received post-immuno-oncology (IO) thera.

No dose-limiting toxicities and treatment-related serious adverse events (SAEs) were observed in the repeated-dose trials of all dose groups, and only grade 1 treatment-related adverse events (TRAEs) occurr.

Plasma pharmacokinetics (PK) were approximately linear, and activated ADG126 steadily accumulated during repeated dosing at different dose leve.

As the first clinical data to validate the precise masking technology of SAFEbody safe antibodies, the total half-life of ADG126 increased by 7 times, and the increase in PK of activated ADG126 in humans indicates that the safe antibodies are directionally activated in the tumor microenvironment (TME) and accumulate steadily And prolong the exposure of the drug in tumor tissue to enhance the effe.

Showing early antitumor activity, two patients with cold tumor who had received multiple lines of therapy, one with ovarian tumor, and the other with disease progression after nivolumab and ipilimumab combination therapy of uveal melanoma, the tumors at the target lesions of both patients continued to shrink and exceeded 20% after administration, and the number of CD8+ T cells increased, probably because the activated ADG126 in the TME steadily increased after repeated administration at a low dose of 1 mg/.

accumulation to functi.

Ovarian cancer patients received a seventh treatment with ADG126 at a dose of 1 mg/kg, and the tumor biomarker CA-125 value, which characterizes clinical benefit, decreased by up to 7

As of February 15, 2022, 5 of the 16 patients had stable disease, including patients with ovarian cancer and patients with uveal melano.

In this trial, the dose was escalated to 20 mg/kg, and an expansion at the 10 mg/kg dose has also been initiat.