First-line SQ-NSCLC approved! Akeso benefits a large population of lung cancer patients

On January 16, 2023, Akeso announced that Chia Tai Tianqing Akeso, a differentiated PD-1 monoclonal antibody ® (PEPLIMAB injection), independently developed by the Company and jointly developed and commercialized by CT Tianqing Pharmaceutical Group, a subsidiary of China Biologics, has been approved by the National Medical Products Administration for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) in combination with chemotherapy. This is Anicore's ® second approved indication after Hodgkin lymphoma.

Lung cancer is the malignant tumor with the highest incidence and mortality in China, and there are about 800,000 new cases of lung cancer in China every year, of which about 20% are squamous cell carcinoma. Anican ® has been approved for the SQ-NSCLC indication, which will further expand the applicable population and significantly enhance social value and commercial value.

Previously, based on excellent data from the randomized, double-blind, multicenter phase III clinical study (AK105-302) of peamplimab plus paclitaxel plus carboplatin versus placebo plus paclitaxel plus carboplatin in the first-line treatment of metastatic squamous non-small cell lung cancer (AK105-302), the therapy was included in the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer (2022)" and included in the "Guidelines for the Clinical Application of CSCO Immune Checkpoint Inhibitors (2022)". It confirms the Chinese academic community's affirmation of the excellent efficacy and safety of PEAMPLIMAB.

A total of 350 participants diagnosed with locally advanced or metastatic sq-NSCLC who had not previously received systemic therapy were enrolled in this study.

The results published in ESMO IO 2022 showed that the peamplimab plus chemotherapy group showed consistent efficacy benefit across all efficacy endpoints, significantly reducing the risk of disease progression and death.

The median progression-free survival (mPFS) was 7.6 months (95% CI: 6.83-9.66), which was significantly longer by 3.4 months at 4.2 months (95% CI: 4.17 to 4.34) in the chemotherapy group, HR = 0.44 (95% CI: 0.34-0.56), p<0.00001, and the risk of disease progression or death was reduced by 56%.

The objective response rate (ORR) was as high as 71.4%, which was significantly higher than that of the chemotherapy group (44.0%), with a P<0.00001.

The median OS was 19.8 months (95% CI: 15.70-23.72) in the chemotherapy group, HR = 0.55 (95% CI: 0.40-0.75), p=0.0002, and the risk of death was significantly reduced by 45%. The 30-month OS rate in the pianpulimab plus chemotherapy group was as high as 54.5% (95% CI: 44.5% to 63.%), which brought hope for a longer survival benefit.

In terms of safety, there was no significant difference in the incidence of adverse events and serious adverse events compared with chemotherapy, showing an excellent safety profile of péamplimab.

The principal investigator of this study, Professor Jiao Shunchang, Director of the Department of Medical Oncology, General Hospital of the Chinese People's Liberation Army (301 Hospital), said:

"It is foreseeable that with the comprehensive and in-depth clinical application of immunotherapy, a certain number of patients will need long-term use of PD-1 monoclonal antibody in the near future. As an IgG1 subtype PD-1 monoclonal antibody modified by Fc segment, pianpulimab has shown excellent efficacy in clinical practice for the treatment of hematological tumors and solid tumors, and has outstanding safety characteristics, which not only achieves the goal of long-term survival of tumor patients, but also helps tumor patients obtain a more quality and dignified survival, which is what our oncologists are looking forward to seeing. ”

Professor Han Baohui, co-principal investigator of the study and director of the Department of Respiratory Medicine at Shanghai Jiao Tong University Chest Hospital, said:

"The first-line treatment of sq-NSCLC with pianpulimab combined with chemotherapy significantly reduces the risk of disease progression/death compared with the chemotherapy group, and is better than many similar PD-1 monoclonal antibodies in terms of OS and PFS data. In addition, the incidence of grade ≥3 immune-related adverse events in the experimental group was only 2.9%, which was much lower than that of similar products.

Combined with superior efficacy and safety, PEPRELIMAB is a reassuring choice for clinicians and oncology patients. At present, PEMPLIMAB is recommended as grade II in CSCO guidelines, and it is foreseeable that the approval of marketing will improve its recommended level in lung squamous cell carcinoma and help clinicians better understand and exert its clinical value. ”

Dr. Yu Xia, Founder, Chairman, President and CEO of Akeso, said:

"In China, lung cancer still has a large number of unmet clinical needs, as a new PD-1 monoclonal antibody with a differentiated design, the approval of this new indication will provide a better treatment option for first-line patients with squamous non-small cell lung cancer." Thanks to the efficacy and safety advantages brought by the differentiated design, PEPRELIMAB has been widely used in the treatment of Hodgkin lymphoma in the clinic and has been highly recognized by doctors and patients.

The approval of the first-line treatment of squamous non-small cell lung cancer will further benefit the huge drug population of penpulimab patients in China and accelerate the transformation of the social and commercial value of PEPRELIMAB. Akeso will join hands with CP Tianqing to continue to vigorously promote the commercialization of Anicore ®, bring better drug options to more Chinese cancer patients, and enhance their survival benefits. ”

Mr. Yu Kangxin, President of CP Tianqing Pharmaceutical Group, said:

"As one of the representatives of the research results of domestic original anti-tumor drugs, Penpulimab has a wide layout in lung cancer, nasopharyngeal cancer, hepatocellular carcinoma, head and neck tumors, gastric cancer and Hodgkin lymphoma and other fields.

In addition, the 'double amprian' regimen of peamplimab combined with anlotinib also brings survival benefits to patients with advanced non-squamous non-small cell lung cancer and small cell lung cancer, providing a new treatment option of 'chemo-free'. In the future, CP Tianqing will continue to practice the concept of 'health technology, warm more life', and develop more and better drugs under the guidance of innovation to benefit more patients!" ”