BEIJING, July 14, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428) today announced that Signal Transduction and Targeted Therapy (STTT), a Nature Portfolio journal, published a paper titled "Orelabrutinib versus chemoimmunotherapy in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial." The paper concludes that orelabrutinib significantly prolongs progression-free survival (PFS) and reduces the risk of disease progression or death by 68%. Orelabrutinib achieves deeper and more durable responses, demonstrates a higher overall response rate (ORR), and exhibits an excellent safety profile, positioning it as an effective first-line treatment option for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

The co-corresponding authors of the paper are Professor Jianyong Li from Jiangsu Province Hospital and Professor Lugui Qiu from the Chinese Academy of Medical Sciences, Institute of Hematology & Blood Disease Hospital. The co-first authors are Professor Fei Li from the First Affiliated Hospital of Nanchang University, Professor Keshu Zhou from Henan Cancer Hospital, and Professor Wei Xu from Jiangsu Province Hospital.

The primary endpoint was PFS as assessed by independent review committee (IRC). Secondary endpoints included overall response rate (ORR) and duration of response (DoR) assessed by both IRC and investigators, safety, etc.

Results assessed by the IRC demonstrated that orelabrutinib significantly prolongs PFS, with a hazard ratio (HR) of 0.32 (p < 0.0001). The research team observed consistent trends across all prespecified subgroups. Orelabrutinib showed superior survival benefits over the control group in patients with advanced age, Rai stage III/IV, or presented with high-risk factors such as del(11q), unmutated IGHV, or bulky disease.

The ORR in the orelabrutinib group reached 90.1%, significantly higher than the 79.2% in the control group. A post-hoc updated analysis at 30-month follow-up showed a complete response (CR) rate of 12.1% in the orelabrutinib group. The DoR in the orelabrutinib group was also significantly longer than in the control group, with an HR of 0.30.

From a safety perspective, the incidence of any-grade treatment-related adverse events (TRAEs) with orelabrutinib was comparable to that of the control group, despite a median treatment duration in the orelabrutinib group (nearly 19.3 months) being nearly four times longer than that in the control group (5.2 months).

Orelabrutinib demonstrated an excellent safety profile, with most TRAEs being Grade 1-2. The incidence of Grade≥3 TRAEs was significantly lower in the orelabrutinib group than in the control group, and no treatment-related atrial fibrillation, major bleeding, or second primary malignancies were observed.

Patients-reported quality of life (Qol) data indicated that the overall health status of the orelabrutinib group was superior to that of the control group. From cycle 16 onward, more patients had clinically meaningful improvement with orelabrutinib versus the control group, with the numerical difference increasing over time.

Orelabrutinib has been approved for the first-line treatment of CLL/SLL in China and included in the National Reimbursement Drug List in 2025, benefiting more patients.

Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia in adults. In the last few years, the advent of BTK inhibitors has revolutionized the treatment landscape of CLL/SLL, replacing highly intensive and toxic chemoimmunotherapy regimens as the standard-of-care.

Signal Transduction and Targeted Therapy (STTT) is a Nature Portfolio journal, publishing original research, reviews, and clinical advances. The SCI impact factor released in June 2026 reached 81.2.

Note: The content of this press release is derived from this published article. Full text can be found in https://www.nature.com/articles/s41392-026-02818-x.

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