On December 5, 2023 Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that it will present data in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego from December 9-12, 2023 (Press release, Servier, DEC 5, 2023, View Source [SID1234638174]). The latest data underscores Servier’s commitment to advancing scientific research, including gaining a more robust understanding of real-world treatment patterns for patients with difficult and hard-to-treat cancers.

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"ASH is a tremendous opportunity to connect with the broader hematologic community and share scientific advances with the power to improve the treatment landscape for patients in need of innovation," said David K. Lee, CEO, Servier Pharmaceuticals. "On the heels of our recent FDA approval for TIBSOVO (ivosidenib tablets) in relapsed/refractory IDH1-mutated myelodysplastic syndromes (MDS), the fifth FDA approval for Tibsovo across hematology and solid tumors, our data at this year’s ASH (Free ASH Whitepaper) continue to add to Servier’s leadership in mutant IDH inhibition, including additional evidence for Tibsovo + azacitidine as the standard of care for newly diagnosed IDH1-mutated AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy."

Servier data being presented at ASH (Free ASH Whitepaper) are listed below and are available online on the ASH (Free ASH Whitepaper) website here.

A large retrospective study comparing two first-line combination regimens for newly diagnosed patients with IDH1-mutated acute myeloid leukemia (mIDH1 AML), ineligible for intensive chemotherapy, to gain insight into real-world treatment patterns, effectiveness and safety
A global longitudinal study of patients with AML, with or without mIDH1 disease, who received first-line intensive chemotherapy to gain insight into treatment patterns and clinical outcomes in the real-world setting
An analysis of the Phase 3 AGILE study in patients with newly diagnosed AML, who are not eligible for intensive induction chemotherapy, using next-generation sequencing to determine measurable residual disease (MRD), a negative prognostic marker, among patients who had a best overall response to treatment in the study
A retrospective study in adolescents and young adults with acute lymphoblastic leukemia, to gain real-world insight into treatment approaches for this population across diverse cancer care settings
"As we continue to advance our clinical development programs across hematology, we are simultaneously focused on generating real-world evidence data that can help the entire treatment community gather the broadest picture possible to identify the best individualized treatment options," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "Looking to the future, improving patient outcomes is going to be a collaborative effort across industry, academia and the community. Servier is proud to serve as a bridge across these stakeholders in our goal of improving patient outcomes."

Among Servier data being presented is real-world evidence comparing Tibsovo in combination with hypomethylating agents (HMA) versus venetoclax in combination with hypomethylating agents in patients with newly diagnosed AML (intensive chemotherapy induction ineligible – ICIE ) and a susceptible IDH1 mutation. In the analysis, Tibsovo+HMA elicited a higher complete response (CR) rate versus venetoclax+HMA at 42.9% vs. 26.7% (p=0.007). 6-month event-free survival also favored Tibsovo+HMA at 56.0% vs. 39.6% (p=0.044), as well as 11.5% of patients on Tibsovo+HMA achieving bridge to transplant versus 5.0% on a venetoclax+HMA regimen (p=0.066). The full analysis will be presented on Monday, December 11 at 5:30 p.m. PST.

Additional data being presented at ASH (Free ASH Whitepaper) includes molecular measurable residual disease (MRD) in ICIE patients with newly diagnosed mIDH1 AML treated with Tibsovo+azacitidine, further bolstering the clinical profile of Tibsovo in the front-line setting, as well as real-world analyses examining treatment patterns in both ALL and AML.

Abstract #971 (Oral): A Comparison of Acute Myeloid Leukemia (AML) Regimens: Hypomethylating Agents Combined with Ivosidenib or Venetoclax in Newly Diagnosed Patients with IDH1 Mutations: A Real-World Evidence Study
Date & Time: Monday, December 11, 5:30 p.m.
Lead Author: B. Douglas Smith, M.D., Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Abstract #3816 (Poster): Real-World Treatment Patterns and Clinical Outcomes in Newly Diagnosed Acute Myeloid Leukemia with and without mIDH1 Treated with Intensive Chemotherapy from an International Real-World Database (REAL-IDH)
Date & Time: Sunday, December 10, 6:00 p.m.-8:00 p.m.
Lead Author: Joshua F. Zeidner, The University of North Carolina, Chapel Hill

Abstract #4305 (Poster): Molecular Measurable Residual Disease in Patients with Newly Diagnosed mIDH1 Acute Myeloid Leukemia Treated with Ivosidenib + Azacitidine
Date & Time: Monday, December 11, 6:00 p.m.-8:00 p.m.
Lead Author: Courtney DiNardo, M.D., MSc, The University of Texas MD Anderson Cancer Center, Houston

Abstract #3704 (Poster): Patterns of Care Among Adolescents and Young Adults Treated for Acute Lymphoblastic Leukemia: A Retrospective Study Across Diverse US Practices
Date & Time: Sunday, December 10, 6:00 p.m.-8:00 p.m.
Lead Author: Julie Wolfson, M.D., MSHS, The University of Alabama at Birmingham

On December 5, 2023 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported it recently dosed its first patient in a Phase 1/1b study of the Company’s proprietary IL-2 investigational immunotherapy, DF6215, developed for patients with advanced solid tumors (Press release, Dragonfly Therapeutics, DEC 5, 2023, View Source [SID1234638173]). DF6215 is the second in a pipeline of cytokines Dragonfly is developing to address the high unmet need in patients with advanced cancer and other diseases.

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"DF6215’s therapeutic potential is particularly compelling," said Dr. Benedito A. Carneiro, MD, MS, Associate Director of the Hematology/Oncology Division, Director of the Phase I program at the Lifespan Cancer Institute, and Co-Leader of the Cancer Therapeutics Program at the Legorreta Cancer Center at Brown University. "Dragonfly’s IL-2 preclinical package shows strong anti-tumor activity in cold and hot tumor models and a favorable therapeutic window in cyno, with no signs of Vascular Leak Syndrome or Cytokine Release Syndrome – which we believe powerfully differentiates DF6215 from historic IL-2 drug candidates."

"Dragonfly’s pre-clinical data package on IL-2 is very promising, and we are eager to demonstrate its effects in cancer patients," said Dr. Joseph Eid, President of Research and Development at Dragonfly. "DF6215 is functionally differentiated from other IL-2s, retaining alpha activity, with an expanded therapeutic window compared to other IL-2s, giving DF6215 the potential to stimulate effective anti-tumor activity in patients who are not currently eligible for or adequately responding to current therapies."

DF6215 is the seventh Dragonfly-developed and fourth Dragonfly-owned drug, in the clinic.

"Initiating clinical trials with our second cytokine and the seventh Dragonfly-developed drug candidate underscores the pace with which our team is advancing the development of important new treatment options for patients with cancer and autoimmune disease, as well as the the breadth of Dragonfly’s portfolio of innovative therapeutics," said Bill Haney, CEO and Dragonfly co-founder.

Dragonfly’s DF6215 Phase 1/1b clinical trial is a first-in-human, multi-part, open-label study to investigate the safety, tolerability, pharmacokinetics, biological, and clinical activity of DF6215 in patients with advanced (unresectable, recurrent, or metastatic) solid tumors. DF6215-001 is currently recruiting at multiple sites in the U.S., with sites in additional regions scheduled to open in 2024.

Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT06108479).

On December 5, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused drug development company, reported the closing of its previously announced purchase and sale of up to an aggregate of 4,444,445 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten (10) ordinary shares of the Company, at a purchase price of $0.45 per ADS (or ADS equivalent in lieu thereof), in a registered direct offering (Press release, Kazia Therapeutics, DEC 5, 2023, View Source [SID1234638172]). The Company also issued in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs. The warrants have an exercise price of $0.583 per ADS, are immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were approximately $2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering as working capital for general corporate purposes.

The securities described above (excluding the warrants and ADSs underlying the warrants) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form F-3 (File No. 333-259224) that was originally filed with the Securities and Exchange Commission (the "SEC") on September 1, 2021, and declared effective on September 8, 2021. The offering of such securities in the registered direct offering was made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs representing ordinary shares underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying ADSs may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

On December 5, 2023 SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of the HER2-specific HIRE platform ADC, BL-M07D1, in the Investigational New Drug (IND) application on November 28, 2023 (Press release, SystImmune, DEC 5, 2023, View Source [SID1234638171]). This milestone paves the way for the multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M07D1 in subjects with metastatic or unresectable HER2 expressing cancers in the United States.

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Dr. Yi Zhu, Chief Executive Officer of SystImmune, remarked, "The FDA’s approval of our IND application for BL-M07D1 underscores our commitment to advancing innovative therapies in the field of oncology with our HIRE platform of ADCs. We look forward to collaborating with our clinical partners, trial treatment centers, and global regulatory agencies to contribute meaningfully to the ongoing evolution of cancer treatment."

The clearance of this IND application marks a significant milestone for SystImmune as the company continues to advance its pipeline of therapeutic candidates into global clinical development.

Updated Clinical Trial Results

New results from the ongoing study with the EGFRxHER3 bi-specific HIRE platform ADC, BL-B01D1, in patients with breast cancer treated in the trial registered as NCT05470348, are presented for the first time. Preliminary results demonstrated overall response rates of 44.7%, 31.4% and 39.1% and disease control rates of 91.4%, 94.7% and 87% in an analysis of 38, 35 and 23 pretreated patients with HER2-/HR+, TNBC and HER 2+ patients with breast cancer respectively. No interstitial lung disease (ILD) was observed in 127 patients treated with at least one dose. For more information visit poster: PS08-07 2023 San Antonio Breast Cancer conference.

Updated analysis from an ongoing phase 1 study of the HIRE platform HER2-specific ADC, BL-M07D1 in the trial registered as NCT05461768, continues to demonstrate impressive results in patients with breast cancer. Reported are response rate of 80%, confirmed responses over 60%, and disease control rate of 100% in 50 patients with HER2+ metastatic breast cancer. Prior treatment with HER2 ADCs did not prevent responses to BL-M07D1, as 18 subjects who had received prior ADC therapies showed similar overall response. Preliminary results from the same study demonstrated an overall response rate of 50%, confirmed responses in 28.9% and disease control rate of 86% in an analysis of 38 heavily pretreated patients with HER2 low-expressing metastatic breast cancer. Only 1 patient experienced ILD which was grade 2, in the 130 patients treated. For more information visit poster: PO2-04-03 2023 San Antonio Breast Cancer conference.

Dr. Martin S. Olivo, the Chief Medical Officer at SystImmune, reports the preliminary findings showcased in these two studies, underscoring their backing of the promising activity seen in the HIRE platform. Dr. Olivo emphasized the significance of the FDA clearance for the IND application of BL-M07D1, expressing optimism. "As the clinical development of BL-M07D1 and BL-B01D1 progress, we’re closer to assessing our potential to offer therapeutic pathways for patients diagnosed with breast cancer."

About BL-B01D1

BL-B01D1 is a first-in-class bispecific antibody-drug conjugate (ADC) developed by SystImmune, targeting both EGFR and HER3, proteins that are highly expressed in most epithelial tumors. The tetravalent BL-B01D1 possesses two binding domains blocking each Growth Factor Receptor, which both drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 effectively blocks EGFR and HER3 signals to cancer cells, thereby reducing proliferation and survival signals. Upon antibody-mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death.

The two targets of BL-B01D1 are broadly expressed in epithelial tumors, including NSCLC, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal carcinoma, Gastrointestinal tumors, Gynecological tumors, and others. The therapeutic conjugated toxin of BL-B01D1 comprises SystImmune’s Ex-0115 linker-payload platform, a proprietary Topo1 inhibitor conjugated to the bi-specific antibody by a stable, cleavable linker. Each BL-B01D1 carries 7-8 units of SystImmune’s proprietary ED-04 toxin.

About BL-M07D1

BL-M07D1 is a HER2 specific antibody-drug conjugate (ADC) developed by SystImmune, targeting cancers that express HER2. The trastuzumab-based BL-M07D1 possesses two binding domains specific for the commonly overexpressed cancer growth factor receptor HER2, which drive cancer cell proliferation and survival. BL-M07D1 binding to HER2 leads to its internalization by cancer cells. Upon antibody-mediated internalization, BL-M07D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death.

The target of BL-M07D1, HER2, is highly expressed in solid tumors, including breast cancer, gastric cancer, endometrial cancer, cervical cancer, ovarian cancer, urothelial cancer, biliary tract cancer and others. The therapeutic conjugated toxin of BL-M07D1 comprises SystImmune’s Ex-0115 linker-payload platform, a proprietary Topo1 inhibitor conjugated to the antibody by a stable, cleavable linker. Each BL-M07D1 carries 7-8 units of SystImmune’s proprietary ED-04 toxin.

Clinical studies conducted thus far have demonstrated compelling results for BL-M07D1. In 107 subjects with HER2+ Breast cancer and other HER2+ cancer BL-M07D1 exhibited promising preliminary antitumor activity in patients with both breast cancer and non-small cell lung cancer. The maximum tolerated dose for BL-M07D1 was not reached. The observed toxicities were predominantly hematologic. These findings were recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2023, and the abstract of the clinical study can be accessed at the following link: BL-M07D1 ESMO (Free ESMO Whitepaper) Abstract. These results indicate that further investigations and clinical trials are warranted to fully assess the efficacy and safety profile of BL-M07D1 in a larger and more diverse patient population.

On December 5, 2023 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 interim analysis results of ORIENT-16, the Phase 3 study evaluating sintilimab in combination with chemotherapy compared to chemotherapy for the first-line treatment of advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma was published in The Journal of the American Medical Association (JAMA, IF=120.7) (Press release, Innovent Biologics, DEC 5, 2023, View Source [SID1234638170]). ORIENT-16 the first immunotherapy Phase 3 study published in JAMA for the first-line treatment of gastric cancer, as well as the first immunotherapy Phase 3 in Chinese patients for the first-line treatment of gastric cancer.

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Gastric cancer is one of the most common malignant tumor types globally and nearly half of all cases are diagnosed in China[i]. Advanced gastric cancer generally has very poor prognosis with high unmet medical need. ORIENT-16 demonstrated that sintilimab plus chemotherapy significantly prolongs overall survival in the first line treatment for overall population of gastric cancer. Based on the results of ORIENT-16, sintilimab is recommended by the Chinese Society of Clinical Oncology (CSCO) guidelines for the first-line treatment of gastric cancer. It is also the first and only PD-1 inhibitor included in national reimbursement drug list (NRDL) for the first-line treatment of gastric cancer.

ORIENT-16 has met its primary endpoint at the prespecified interim analysis. Sintilimab in combination with chemotherapy demonstrated superior and clinical meaningful overall survival (OS) benefit, compared with placebo plus chemotherapy in all randomized patients as well as patients with CPS ≥5 . Detailed interim analysis results were published in JAMA.

Interim analysis (cut-off date June 20, 2021, median follow-up 18.8 month) showed that, sintilimab in combination with chemotherapy significantly reduced the risk of death in all randomized patients (HR 0.77, 95%CI 0.63-0.94, p=0.009) and in patients with CPS ≥5 (HR 0.66, 95%CI 0.50-0.86, p=0.002) , successfully reached the prespecified superiority criteria. Median overall survival (mOS) has been prolonged by 2.9months (mOS 15.2mo vs. 12.3mo) in all randomized patients, and 5.5 months (mOS 18.4mo vs. 12.9mo) in patients with CPS ≥5, respectively. In addition, OS benefits were consistent in all prespecified subgroups. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified for the combination of sintilimab and chemotherapy in GC patients.
Furthermore, prespecified final analysis results of ORIENT-16 has been published at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting. Final analysis (with additional 15-month follow-up) indicated that OS benefits of sintilimab plus chemotherapy have become more evident in overall population and in patients with CPS ≥5 compared with that of interim analysis, further confirming sintilimab plus chemotherapy as a standard of care of 1L treatment for G/GEJ adenocarcinoma.

Final analysis (cut-off date September 2, 2022, median follow-up 33.9 mo) showed that, sintilimab in combination with chemotherapy significantly reduced the risk of death in all randomized patients (HR 0.68, 95% CI: 0.57-0.81; P<0.0001) as well as in patients with CPS ≥5 (HR 0.59, 95% CI: 0.47-0.74; P<0.0001) . Median overall survival (mOS) has been prolonged by 2.9months (mOS 15.2mo vs. 12.3mo) in all randomized patients and by 6.3 months (mOS 19.2mo vs. 12.9mo) in patients with CPS ≥5, respectively. OS benefits were consistent in all prespecified subgroup analyses. The overall safety profile of final analysis was consistent with that observed in previously reported interim analysis, and no additional safety signals were identified with additional 15-month follow-up.
Based on the study results of ORIENT-16, sintilimab in combination with chemotherapy was approved by the National Medical Products Administration (NMPA) of China as first-line treatment for G/GEJ in June 2022, and was included in the national reimbursement drug list (NRDL), becoming the first and only immunotherapy for gastric cancer covered by NRDL in China.

The principal investigator of the ORIENT-16 study, Prof. Jianming Xu from the Fifth Medical Center of People’s Liberation Army General Hospital, stated, "ORIENT-16 is the first phase 3 trial in China to demonstrate a significant overall survival benefit in patients with advanced G/GEJ cancer treated with anti-PD-1 antibody plus chemotherapy in first line setting. The study has met its primary endpoint in the prespecified interim result analysis, and its final analysis demonstrated the OS benefit of sintilimab plus chemotherapy in overall population and in patients with CPS ≥5 compared with chemotherapy alone. ORIENT-16 confirms sintilimab plus chemotherapy as an important new treatment option and a standard of care of first line treatment for G/GEJ adenocarcinoma."

Dr. Zhou Hui, Senior Vice President of Innovent, stated, "The treatment options for advanced G/GEJ cancer are relatively limited and the ORIENT-16 study aimed to address this urgent unmet medical need. ORIENT-16 is the first randomized controlled Phase 3 study in China to demonstrate that PD-1 in combination with chemotherapy significantly prolongs overall survival in overall population of first line treatment for G/GEJ adenocarcinoma. The publication in JAMA further confirms its huge clinical value of the ORIENT-16 study. We are grateful for all the contributions made by every investigator and patient in this study. Up until now, sintilimab is the only PD-1 inhibitor in China approved and included in NRDL for the first-line treatment of five major types of cancer – non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, and gastric cancer. Sintilimab is also the first and only immunotherapy for gastric cancer covered by NRDL. We hope this novel immunotherapy to benefit a wider group of cancer patients."

About the ORIENT-16 Study

ORIENT-16 is a randomized, double-blind, multicenter Phase 3 clinical study evaluating sintilimab in combination with chemotherapy, compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (ClinicalTrials.gov, NCT03745170). The primary endpoint was overall survival, in all randomized and in PD-L1 positive patients.

About Gastric Cancer

Gastric cancer is one of the most common malignant tumor types worldwide. According to GLOBOCAN estimates, there were approximately one million new cases and 769,000 new deaths of gastric cancer in 2020, making it the fifth most common cancer and third leading cause of cancer death globallyi[ii]. About half of all gastric cancer cases occurred in East Asia, mainly in Chinai. The first-line treatment of advanced gastric cancer remains limited. Currently, the 5-year survival rate of advanced or metastatic gastric cancer ranges from 5 to 20 percent. The median survival was about 1 year for patients who received chemotherapy only[iii][iv].

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[v]. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for seven indications and included in the National Reimbursement Drug List (NRDL) for six indications. The updated NRDL reimbursement scope of TYVYT (sintilimab injection) include:

For the treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
For the treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
For the treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
For the treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
For the treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy.
Additionally, sintilimab has been approved in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) for the treatment of patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy.

Besides, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.
Statement: Innovent does not recommend the use of any unapproved drugs/indications.