On June 5, 2022 Lytix Biopharma AS ("Lytix" or the "Company"), a clinical-stage company with an in situ vaccination technology platform, reported data from its ATLAS-IT-04 trial in patients with progressive metastatic soft tissue sarcoma (STS) (Press release, Lytix Biopharma, JUN 5, 2022, View Source [SID1234615594]). The data from this Phase II proof of concept study shows that LTX-315 in combination with Adoptive Cell Therapy (ACT) was able to stabilize the disease in 3 out of 4 fully treated patients in this hard-to-treat patient population, and that the LTX-315 treatment generated tumor-specific T cells.

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The data is presented June 5th, 2022, as a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, Chicago, IL, U.S.A.

The ATLAS-IT-04 trial was an open label, exploratory, Phase II trial assessing the effect of LTX-315 when used in combination with ACT in patients with metastatic STS. ACT with tumor infiltrating lymphocytes (TILs) is a potent treatment that can induce complete and durable tumor regression as documented in patients with melanoma. The use of ACT with TILs for patients with advanced STS has not previously been reported.

Patients with advanced stages of STS have few effective treatment options and respond poorly to current treatment as well as to immunotherapy tested in clinical trials. The trial design of ATLAS-IT-04 included intratumoral injections of LTX-315 ahead of surgical removal of tumors, followed by in vitro expansion of T cells as the first step. In a second step, the expanded T cells were infused back to the patients and the effect of LTX-315 on the tumor microenvironment was assessed.

LTX-315 is a first-in-class non-viral oncolytic molecule, representing a new and superior in situ therapeutic vaccination principle to boost the clonal expansion of T cells that kill tumor cells through a targeted immune response. In a recent Phase I/II study LTX-315 has been shown to increase TILs in malignant solid tumors after intratumoral injection.

The immune response data from the ATLAS-IT-04 trial demonstrates that the treatment induce both new and tumor-specific T cells which provides proof to the concept that LTX-315 generates an immune response that targets the tumor. Moreover, the data shows that LTX-315 induce expansion of a heterogenous pool of T-cell clones in blood, and a pool of these are also present in tumor tissue after treatment.

"This trial demonstrates that the combination of LTX-315 and ACT is not only feasible and tolerable, but that tumor-specific T cells can be expanded in vitro from tumors that have been pretreated with the oncolytic molecule LTX-315", Inge Marie Svane, PI and Professor at the National Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, comments.

She adds: "This combination therapy invokes tumor specific T cells that can be cultured and infused as part of an adoptive transfer regimen for several subtypes of soft tissue sarcoma, and its treatment schedule should be further optimized to achieve superior signs of efficacy."

The poster is presented June 5th at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting.

On June 5, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, reported that the China National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Equecabtagene Autoleucel (Innovent R&D code: IBI326，IASO Bio R&D code: CT103A) , a fully human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) (Press release, Innovent Biologics, JUN 5, 2022, View Source [SID1234615593]).

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Equecabtagene Autoleucel is the first CAR-T therapy in China that is self-developed with proprietary whole-process product development and the first BCMA-targeting CAR T-cell therapy in China with its NDA formally accepted by the NMPA. It is an innovative therapy co-developed by IASO Bio and Innovent. In February 2021, Equecabtagene Autoleucel was granted "Breakthrough Therapy Designation" by the NMPA.

The acceptance of NDA is based on data from a single-arm, open-label, multi-center phase 1/2 study（NCT05066646）being conducted in China. Study results showed that Equecabtagene Autoleucel has excellent safety and efficacy profiles, low immunogenicity given a fully-human scFv, robust expansion and prolonged persistence in vivo. It will potentially offer a breakthrough treatment option for patients with R/R MM. The data from the phase 1/2 clinical study of Equecabtagene Autoleucel was presented in an oral presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Abstract #547) and the updated data was accepted as an oral presentation at the 27th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper)（EHA）Virtual Meeting (Abstract #S187) , held on June 9-12, 2022.

"Multiple Myeloma (MM) is the second-most-common hematologicmalignancy. Although the survival in MM patients has been dramatically extended to 7-10 years on average with recent drug development, the disease is still incurable and relapse or refractory after standard therapies is common for most MM patients. The later lines of treatment the patients are receiving, the shorter of survival time for those patients. Usually, the median progression-free survival of MM patients who had received at least third-line of prior therapy is only 3-6 months, and the overall survival time is less than 1 year. In recent years, there have been some encouraging breakthroughs in drugs and therapeutic interventions for the treatment of MM. The most exciting progress is BCMA CAR-T cell immunotherapy." said the two principal investigators at the primary study sites – Prof. Lugui Qiu, MD, from the Chinese Academy of Medical Science Hematology Hospital and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology. "At the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in 2021, we reported the results of the clinical study on Equecabtagene Autoleucel injection. The study was conducted in 14 clinical centers and enrolled 79 patients with MM who had received at least third-line of prior therapy. Of the 79 patients, the overall response rate(ORR) was 94.9% and the complete response/stringent complete response (CR/sCR) rate was 58.2%. These study results showed that Equecabtagene Autoleucel has excellent safety and efficacy profiles. In addition, Equecabtagene Autoleucel also demonstrated favorable efficacy in patients with extramedullary multiple myeloma and patients who had received prior CAR-T therapy. These results suggest that Equecabtagene Autoleucel is potentially a new and effective immunotherapy treatment option for patients with multiple myeloma. We hope that Equecabtagene Autoleucel can be launched in China soon, bringing long-term benefits to patients."

Dr. Yongjun Liu, President of Innovent, said, "We are glad about the NDA acceptance of Equecabtagene Autoleucel, a product candidate co-developed by Innovent and IASO Bio, and it will potentially to be the domestic first approved and launch-to-market BMCA CAR-T therapy for multiple myeloma. In the clinical studies, Equecabtagene Autoleucel demonstrated impressive efficacy and favorable safety profiles. We hope that this breakthrough therapy could be approved in the near future and we will actively coordinate with all parties including the government authorities, hospitals, commercial insurance and charity funds to bring benefit to more multiple myeloma patients.

"IASO Bio currently has more than 10 innovative pipeline products under development. Equecabtagene Autoleucel is China’s first domestically developed CAR T-cell therapy with global intellectual property rights and the first BCMA-targeting CAR T-cell therapy with its NDA formally accepted by the NMPA. This is a significant milestone for IASO Bio. IASO Bio’s over 100,000 ft² manufacturing facility in Nanjing, which has end-to-end manufacturing capability that covers the entire CAR-T production process, received its drug manufacturing license earlier this year, will be the future commercial production site for Equecabtagene Autoleucel." said Wen (Maxwell) Wang, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of IASO Bio.

"In 2018, Professor Jianfeng Zhou of Tongji Hospital，Tongji Medical College led a team of clinicians and biologists to initiate clinical study of the world’s first fully-human BCMA CAR T-Cell therapy (Equecabtagene Autoleucel) for the treatment of multiple myeloma. The first patient of the study has maintained strict complete remission (sCR) for over 40 months." Maxwell added, "Many thanks to Professor Jianfeng Zhou for his unremitting efforts to promote the development of novel cell therapies and provide the impetus for the continuous innovation of CAR-T therapy. We look forward to the commercialization of Equecabtagene Autoleucel to bring hope to more multiple myeloma patients."

Innovent and IASO Bio are actively advancing the clinical development of Equecabtagene Autoleucel. In February 2022, it was granted "Orphan Drug Designation (ODD)"by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA). In January 2022, IASO Bio and Innovent have jointly granted non-exclusive commercial rights of the fully-human BCMA CAR construct used in Equecabtagene Autoleucel to Sana Biotechnology (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, for use in its in vivo gene therapy and ex vivo hypoimmune cell therapy applications. Sana’s clinical and commercial development could further enhance the potential value of IBI326, benefitting a broader patient population. In addition to multiple myeloma, the NMPA has accepted IND application of Equecabtagene Autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

About Multiple Myeloma (MM)

In the United States, MM accounts for nearly 2% of new cancer cases, and more than 2% of all cancer-related deaths. According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025.

On June 5, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported the preliminary data of IBI351 (GFH925) (KRASG12C inhibitor) from dose escalation portion of a phase I clinical trial (NCT05005234) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 5, 2022, View Source [SID1234615592]).

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Phase I dose-escalation study of IBI351 (GFH925) monotherapy in patients with advanced solid tumors

Poster Presentation, Abstract #: 3110

IBI351(GFH925) is a novel, irreversible covalent inhibitor of KRASG12C mutation. The NCT05005234 study presented was a first-in-human study conducted in China to evaluate the safety, tolerability and efficacy of IBI351 monotherapy in patients with advanced solid tumors who failed or intolerant to standard of care treatment. As data cutoff (15 April 2022), 31 subjects were enrolled in the study, including 25 patients with non-small cell lung cancer, 5 colorectal cancer and 1 pancreatic cancer. Approximately 30% patients received 3 lines or above prior systemic anticancer therapy. The highlights of the study results were as follows:

Of 21 patients (including 16 non-small cell lung cancer and 5 colorectal cancer) having at least 1 tumor assessment per RECISTv1.1, 9 achieved PR, with investigator assessed ORR 42.9% and DCR 81%.
Of 12 patients with NSCLC treated at/above doses of 700mg once daily, 6 achieved PR, with investigator assessed ORR 50% and DCR 83.3%.
Of 5 CRC patients, 2 achieved PR, with investigator assessed ORR 40% and DCR 60%.
As data cutoff, IBI351 was well tolerated. No DLT was reported and MTD was not reached. Treatment-related adverse events (TRAEs) occurred in 93.5% (29/31) patients and the most common TRAEs were anemia, transferase increased, bilirubin increased, vomiting and diarrhea. The majority of the TRAEs were grade 1-2 with 12.9% (4/31) of patients reporting grade 3 TRAEs. There were no grade 4-5 TRAEs or TRAEs led to treatment discontinuation.
Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed in previously-treated advanced non-small cell lung cancer and colorectal cancer harboring KRASG12C mutation. As data cutoff, dose escalation is still ongoing. More data will be presented at the future medical meeting.

Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, stated: "KRASG12C mutation occurs in about 2~4% of non-small cell lung cancer and 2.5% of colorectal cancer in China, and no KRASG12C inhibitor was approved yet in China. IBI351 is a novel, irreversible covalent inhibitor of KRASG12C mutation. The preliminary data shows the favorable safety and promising activity of IBI351 (GFH925) monotherapy in KRAS G12C mutated advanced solid tumor. We look forward to more positive clinical data from this study. "

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2022 ASCO (Free ASCO Whitepaper), and that IBI351 monotherapy demonstrated encouraging efficacy and safety data in phase I dose-escalation study. We are working to advancing into late stage clinical development to explore the potential of IBI351 in monotherapy and combo-therapy. We hope to benefit more cancer patients as we are exploring next-generation immunotherapies."

To learn more about Innovent’s R&D updates and activities at 2022 ASCO (Free ASCO Whitepaper), please visit View Source

About IBI351/GFH925 (KRASG12C Inhibitor)

Discovered by GenFleet Therapeutics, GFH925 (Innovent R&D code: IBI351) is a novel, orally active, potent KRASG12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRASG12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of IBI351 towards G12C. Subsequently, IBI351 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest. In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of IBI351 in China (including mainland China, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.

On June 5, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that clinical data of IBI110 (anti-LAG-3 monoclonal antibody) from three clinical trials will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 3-7, 2022 (Press release, Innova Therapeutics, JUN 5, 2022, View Source [SID1234615591]). This includes clinical data from a Phase Ia/Ib clinical study and preliminary results from two Phase Ib Proof-of-Concept (PoC) clinical studies for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) and advanced gastric cancer (GC).

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IBI110 (anti-LAG-3 mAb) as a single agent or in combination with sintilimab (anti-PD-1 mAb) in patients with advanced solid tumors: updated results from the Phase Ia/Ib dose-escalation study

Poster Presentation, Abstract #: 2650

This is a first-in-human, Phase Ia/Ib study of IBI110 in patients with advanced solid tumors, including Phase Ia IBI110 monotherapy and Phase Ib combination therapy of IBI110 and sintilimab. The highlights for the study results were as follows:

39 patients with advanced solid tumors who failed standard of care therapy were treated with IBI110 (≥ 3 mg/kg) in combination with sintilimab and received at least 1 post-baseline tumor assessment. 6 patients achieved partial response (PR); the objective response rate (ORR) was 15.4% and the disease control rate (DCR) was 64.1%.
31 patients with advanced NSCLC who failed standard of care, and 6 patients achieved PR; the ORR and DCR were 19.4% and 74.2%, respectively.
For safety results, no dose limiting toxicity (DLT) was observed in either Phase Ia or Ib dose escalation. In Phase Ib dose escalation, treatment-related adverse events (TRAEs) occurred in 75.6% (34/45) patients, most of which were grade 1-2, and the most common TRAEs were aspartate aminotransferase increased (28.9%), anemia (24.4%) and alanine aminotransferase increased (22.2%).
Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in first-line advanced squamous non-small cell lung cancer (sqNSCLC): initial results from a Phase Ib study

Abstract #: e21145

In this Phase Ib study, the efficacy and safety of IBI110 in combination with sintilimab as first-line therapy for advanced sqNSCLC was evaluated.

20 untreated advanced sqNSCLC patients received 200 mg IBI110 combined with sintilimab and chemotherapy and received at least 1 post-baseline tumor assessment. As of the data cutoff date of Jan 20, 2022, 16 patients achieved PR, the ORR was 80%. The study is still ongoing and will continue to monitor depth of response overtime.
For safety results, the most common TRAEs ≥ grade 3 were neutrophil count decreased (30%) and white blood cell count decreased (20%). Immune-related AEs occurred in 11 patients (55%) and most were grade 1-2. There were no treatment-related deaths or TRAEs led to treatment discontinuation.
IBI110 alone or plus sintilimab indicate a manageable safety profile andpromising antitumor activity from the preliminary data. The study is ongoing with the clinical data in squamous NSCLC is continuing to mature and will be presented in the future.
Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: preliminary results from a Phase Ib study

Abstract #: e16097

In this Phase Ib study, the efficacy and safety of IBI110 in combination with sintilimab as first-line therapy for advanced GC was evaluated.

15 untreated advanced GC patients received 200 mg IBI110 combined with sintilimab and chemotherapy and received at least 1 post-baseline tumor assessment. At the cut-off date of January 20, 2022, 9 patients achieved PR; the ORR and DCR were 60% and 100%, respectively. Up to the press release date, the ORR reached 76.5% and most patients were still in treatment.
The most common TRAEs ≥ grade 3 were neutrophil count decreased (11.1%), platelet count decreased (11.1%) and hepatic function abnormal (11.1%). Immune-mediated AEs occurred in 7 pts (38.9%). One patient discontinued treatment due to coronary artery disease. There were no treatment-related deaths.
Professor Caicun Zhou, Shanghai Pulmonary Hospital, stated: "Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide, of which non-small cell lung cancer accounts for about 80%. In recent years, PD-1/PD-L1 inhibitors have shown promising efficacy in non-small cell lung cancer. However, persistent response to immune checkpoint inhibitor monotherapy remains a challenge in clinical practice. IBI110 plus sintilimab indicate a manageable safety profile and promising antitumor activity in untreated squamous non-small cell lung cancer patients. The ORR reached 80%, suggesting that it is worth further exploring the safety and efficacy of IBI110 combination therapy in this indication."

Professor Nong Xu, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Immune checkpoint inhibitors have shown good efficacy in a variety of tumors, but clinical challenges still remain. A key part of the mechanism of action is the synergistic inhibition of LAG-3 and PD-1 could have the potential to enhance the immune response and inhibit tumor growth. We are encouraged by the results we’ve seen to date in this study and the potential of this medicine."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2022 ASCO (Free ASCO Whitepaper) Meeting. IBI110 in combination with sintilimab demonstrated encouraging efficacy and safety data in sqNSCLC and GC. We will continue to update on PoC data readout for IBI110 in treatment areas such as lung cancer and plan to initiate subsequent pivotal clinical studies. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune checkpoint inhibitors, among which IBI110 represents a high-potential LAG-3 asset, and we hope it could benefit more patients in need soon."

To learn more about Innovent’s R&D updates and activities at 2022 ASCO (Free ASCO Whitepaper), please visit View Source

About IBI110

IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody independently developed by Innovent Biologics (Suzhou). Based on the mechanism of action and preclinical data of IBI110, it is assumed that IBI110 can inhibit the immune checkpoint signaling to achieve anti-tumor effect, which may further improve the efficacy of immunotherapy, overcome the primary drug resistance, and overcome the drug resistance after anti-PD-1 /PD-L1 monoclonal antibody treatment. Based on the urgent clinical needs, Innovent Biologics has carried out clinical studies to explore PK/PD characteristics of IBI110 single drug and combined with sintilimab in human body as well as its efficacy and safety in various advanced tumors. This is the first in human clinical study of IBI110.

On June 5, 2022 Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported that clinical details in poster presentation featuring phase Ib/II study of its Ivonescimab (PD-1/VEGF BsAbs, AK112) in advanced non-small cell lung cancer (NSCLC) at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Akeso Biopharma, JUN 5, 2022, View Source [SID1234615589]).

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Summary of the clinical results:

AK112 was safe and well tolerated, with no significant difference between squamous NSCLC (SQ-NSCLC) and non-squamous NSCLC (NSQ-NSCLC) patients. The incidence rate of grade 3-4 TRAE was 13.5%, with no TRAE leading to permanent treatment discontinuation.
Among 54 treatment-naïve patients with PD-L1 positive (PD-L1 TPS≥1%) who had at least one post-treatment tumor assessment, the objective response rate (ORR) was 50.0% and disease control rate (DCR) was 96.3%.
Among 50 treatment-naïve patients receiving AK112 >10 mg/kg Q3W, AK112 presented encouraging anti-tumor efficacy in different PD-L1 expression levels:
In patients with PD-L1 positive patients (TPS ≥ 1%), ORR was 60.0% and DCR was 97.1%.
In patients with TPS 1%-49%, ORR was 50.0% and DCR was 95.5%.
In patients with TPS ≥50%, ORR was 76.9% and DCR was 100.0%.
This is a multicenter, phase Ib/II, open-label study of AK112 monotherapy in advanced NSCLC (NCT04900363). As of 4 March, 2022, 96 patients were enrolled, 90 of whom had at least one post-treatment tumor assessment. The dose-selection part was divided into four different dosing regimens including 10 mg/kg Q3W, 20 mg/kg Q2W, 20 mg/kg Q3W or 30 mg/kg Q3W, with safety and ORR as the primary endpoints.

Akeso is conducting a phase III study of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III study of AK112 plus chemotherapy versus chemotherapy in EGFR+ advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy (NCT05184712) is ongoing. AK112 has been investigated for different stages of treatment for both NSCLC and small cell lung cancer.

Related Study

KEYNOTE-042 study is a clinical study in patients with PD-L1 positive (TPS ≥ 1%) locally advanced/metastatic non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations. According to this study, ORR was 27.0% in patients with PD-L1 TPS≥1%) and 39.0% in patients with TPS≥50% in the Pembrolizumab group.[1][2]

Reference

[1] Mok TSK, Wu YL, Kudaba I, et al. KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7.

[2] Disclaimer: the study mentioned above is for reference only. It doesn’t necessarily represent the latest clinical study ongoing for the same indication, and it is not a head-to-head study derived from AK112 clinical trial.