荣昌生物公布RC148一线治疗NSCLC的Ib期数据及III期方案

The 2026 World Conference on Lung Cancer (WCLC 2026) was held in Seoul, South Korea, on September 12 to 15, 2026 (GMT +9). As the world's largest academic conference on lung cancer research, WCLC brought together experts and researchers from over 100 countries to show the latest breakthroughs and major advancements in lung cancer treatment.

Two clinical trials on RC148 (ABBV-1480), a novel PD-1/VEGF bispecific antibody, were presented during the conference via oral presentation and poster, showcasing the latest advancement in development of this investigational agent for treatment of lung cancer. Newly released data from RC148-C002 (NCT06883630) showed that at the 10 mg/kg dose, the objective response rate (ORR) was 90% among participants with squamous non-small cell lung cancer (NSCLC) (93.3% in the PD-L1-negative [TPS<1%] subgroup) and 75.9% among those with non-squamous NSCLC (74.1% in the PD-L1-negative [TPS<1%] subgroup), and median progression free survival (PFS) was 11.8 month and 11.1 months respectively which may continue to improve with longer follow-up. The protocol of RC148-C301 (NCT07416474), a phase III clinical study of RC148 as first-line treatment of squamous NSCLC, was presented via poster.

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RC148-C002: Encouraging Preliminary Efficacy Observed Among Participants with Treatment-Naïve Squamous and Non-Squamous NSCLC Across All PD-L1 Expression and Age Subgroups

At the "Breakthrough Immunotherapy for Advanced NSCLC" session, Professor Yuanyuan Zhao from the Sun Yat-sen University Cancer Center made an oral presentation on RC148-C002, updating attendees with the latest clinical data.

RC148-C002 is a multicenter, open-label phase 1b clinical study conducted in China to evaluate the efficacy, safety, and pharmacokinetic characteristics of RC148 combined with chemotherapy as first-line treatment for locally advanced or metastatic NSCLC. The study enrolled treatment-naive patients with unresectable Stage IIIB/C or Stage IV actionable genomic alteration (AGA)-negative NSCLC. Cohort 1 included patients with squamous NSCLC (sqNSCLC), who were randomized in a 1:1 ratio to receive RC148 (10 or 20 mg/kg) combined with carboplatin/paclitaxel for 4 cycles, followed by RC148 monotherapy maintenance treatment; Cohort 2 included patients with non-squamous NSCLC (nsqNSCLC), who were randomized in a 1:1 ratio to receive RC148 (10 or 20 mg/kg) combined with carboplatin/pemetrexed for 4 cycles, followed by RC148 combined with pemetrexed maintenance therapy. The primary endpoint was ORR, and secondary endpoints included disease control rate (DCR), duration of response (DoR), PFS, overall survival (OS), and safety. Professor Li Zhang from the Sun Yat-sen University Cancer Center was the principal investigator.

As of June 22, 2026, 61 patients with sqNSCLC and 60 patients with nsqNSCLC were enrolled. The data showed a favorable clinical efficacy and manageable safety profile with RC148 combined with chemotherapy.

● In the RC148 10 mg/kg group of Cohort 1 (sqNSCLC), at a median follow-up of 11.7 months, ORR reached 90.0%, with confirmed ORR (cORR) of 76.7%; median PFS was 11.8 months, and median DoR and OS were not yet reached. Notably, in the PD-L1-negative (TPS<1%) subgroup, ORR was 93.3%, and cORR was 86.7%. In the subgroup analysis by age, ORR was 90.0% and cORR was 85% among patients aged 65 or older, indicating that tumor response may be achieved among adult patients of all ages on that regimen.

● In the RC148 10 mg/kg group of Cohort 2 (nsqNSCLC), at a median follow-up of 12.3 months, ORR reached 75.9%, with cORR of 72.4%; median PFS was 11.1 months, median DoR and OS were not yet reached, and favorable trends were observed in both PFS and OS. Notably, in the PD-L1-negative (TPS<1%) subgroup, ORR was 71.4%, and cORR was 64.3%. In the subgroup analysis by age, ORR was 100.0% and cORR was92.9% among patients aged 65 or older, indicating that tumor response may also be achieved among adult patients of all ages on this regimen.

● In terms of safety, no Grade ≥ 3 haemorrhage events occurred in the 10 mg/kg dose groups of either cohort; the common treatment-related adverse events (TRAEs) were chemotherapy-related hematologic toxicity. This overall manageable safety profile supports the ongoing and future Phase 3 development for RC148.

As indicated by the updated clinical data, RC148 combined with chemotherapy demonstrated encouraging preliminary antitumor activity and acceptable safety as the first-line treatment for adult patients with sqNSCLC or nsqNSCLC, regardless of PD-L1 expression status and age. The 10 mg/kg dose, with superior outcomes across histological subtypes, is the recommended phase 3 dose in first-line NSCLC. Currently, pivotal phase III studies have been initiated or planned both in China and abroad, including a phase III study on RC148 combined with chemotherapy as a first-line treatment for sqNSCLC which is actively recruiting patients in China; a phase III study on RC148 combined with chemotherapy as a first-line treatment for nsqNSCLC which is about to be initiated in China, and a global phase III study, with AbbVie Inc. as the partner, on RC148 combined with chemotherapy as a first-line treatment for NSCLC which is actively recruiting patients.

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RC148-C301: Proceed Smoothly to Change the Treatment Landscape of sqNSCLC

Squamous NSCLC accounts for approximately 20%-30% of all NSCLC. Patients with sqNSCLC feature low prevalence of AGA, and therefore have limited choice of targeted therapies. The median PFS of the current first-line standard immunotherapy plus chemotherapy is only 6-8 months, and the clinical benefit remains less favorable. As a novel PD-1/VEGF bispecific antibody, RC148 achieves synergistic efficacy of immune activation and anti-angiogenesis by simultaneously blocking two pathways, with a potential to reduce haemorrhage risks associated with the anti-angiogenic treatment, improving the immune responses in the PD-L1-low/negative population; and potentially further extending median PFS, overcoming the efficacy limitations of the current SOC.

RemeGen initiated the study RC148-C301 in March this year and the protocol for this study was released at the conference. RC148-C301 is a randomized, double-blind, multicenter phase III clinical study conducted in China to evaluate the efficacy and safety of RC148 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in sqNSCLC participants. The primary endpoint is the PFS assessed by a blinded independent review committee (BIRC), and the key secondary endpoint is OS. The study is planned to enroll 574 patients across 67 medical institutions in China, with Professor Li Zhang and Professor Yun Fan from Zhejiang Cancer Hospital serving as co-principal investigators.

The two studies announced at this conference clearly demonstrate the therapeutic potential and development path of RC148 in the field of lung cancer treatment. Currently, RemeGen is actively moving forward the clinical studies on RC148 as monotherapy and in combination therapies in patients with various advanced malignant solid tumors in China. It is believed that with the progress of studies and the accumulation of clinical data, the evidence base is expected to be further enhanced, bringing better treatment options for cancer patients.