On December 2, 2021 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported the completion of patient recruitment in the Phase 3 SIENDO study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer (Press release, Karyopharm, DEC 2, 2021, View Source [SID1234596398]).

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Endometrial cancer is the most common cancer of the female reproductive organs, with more than 66,000 new cases in the US in 2021.1 Unfortunately, prognosis is poor with an estimated 14,000 women progressing to advanced disease.2 There are currently no approved therapies in the maintenance setting for patients with advanced or recurrent endometrial cancer.

"There is a clear and significant need for treatments that help extend remission or delay disease progression following front-line chemotherapy treatment in patients with endometrial cancer," said Sharon Shacham, PhD, Chief Scientific Officer of Karyopharm. "Completing enrollment in the Phase 3 SIENDO study is an important step toward our goal of delivering a novel, front-line maintenance therapy for patients and positive data from this study will further reinforce our views on the therapeutic potential of selinexor in solid tumor indications. We anticipate reporting top-line data from this event-driven study by the end of this year or early next year."

The SIENDO study has exceeded its enrollment goal, with over 250 patients currently enrolled or in screening. The SIENDO study is a multicenter, blinded, placebo-controlled, randomized Phase 3 study evaluating the efficacy and safety for maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who had a partial or complete response after a single line of at least 12 weeks of standard taxane-platinum combination chemotherapy are randomized in a 2:1 manner to receive either maintenance therapy of 80mg of selinexor taken once per week or placebo, until disease progression. The primary endpoint in the study is progression free survival with the goal of the study demonstrating a hazard ratio of 0.6.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

On December 2, 2021 BeiGene (NASDAQ:BGNE; HKEX:06160), a global science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that three of its medicines have been added to the most recent National Reimbursement Drug List (NRDL) in China by the National Healthcare Security Administration (NHSA) (Press release, BeiGene, DEC 2, 2021, View Source [SID1234596416]). BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. The changes to the NRDL will be effective on January 1, 2022.

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"The inclusion of our three internally-discovered innovative medicines in the latest NRDL will help expand access to these high-quality oncology treatments across China at affordable prices and reduce the financial burden for patients and their families"

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"The inclusion of our three internally-discovered innovative medicines in the latest NRDL will help expand access to these high-quality oncology treatments across China at affordable prices and reduce the financial burden for patients and their families," commented Xiaobin Wu, Ph.D., President of BeiGene, Chief Operating Officer, and General Manager of China. "Since its establishment, the NHSA has accelerated the frequency of adjustment to the NRDL, forming a dynamic mechanism for annual updates. Through the establishment of a comprehensive healthcare system, life-saving innovative oncology medicines are now more quickly included in the NRDL at affordable prices, covering different types of medical care and providing benefits for people living with cancer. As an innovative company with strong R&D capabilities and global reach, BeiGene is working to change the status quo in the field of treatment and fill the gap in clinical treatment options. We look forward to working with the NHSA to fulfill the demand for these treatments across China as soon as possible."

The following indications have been included in the updated NRDL:

Tislelizumab is now included in the NRDL in all five of its approved indications – three new indications in 2021 and two indications included last year:
For use in combination with pemetrexed and platinum chemotherapy as a first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), with EGFR genomic tumor aberrations negative and ALK genomic tumor negative (approved in June 2021 and included in the NRDL in 2021);
For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy (conditionally approved in June 2021 and included in the NRDL in 2021);
For use in combination with paclitaxel and carboplatin as a first-line treatment in patients with unresectable, locally advanced or metastatic squamous NSCLC (approved in January 2021 and included in the NRDL in 2021);
For the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (conditionally approved in April 2020 and included in NRDL in 2020); and
For the treatment of patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies (conditionally approved in December 2019 and included in the NRDL in 2020).
BRUKINSA is now included in the NRDL in all three of its approved indications – one new indication in November 2021 and two indications included last year:
For the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy (conditionally approved in June 2021 and included in the NRDL in 2021);
For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020); and
For the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020).
Pamiparib is initially included in the NRDL in its approved indication:
For the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (conditionally approved in May and included in the NRDL in 2021).
About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first approved medicine from BeiGene’s immuno-oncology biologics portfolio and is being further developed globally as a monotherapy and in combination with other agents for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. NMPA also granted conditional approval for the treatment of patients with cHL who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic UC with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with HCC who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, four supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA and are under review for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).

In the United States, a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022. BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials. In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan. Tislelizumab is not approved for use outside of China.

About BRUKINSA (zanubrutinib)

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in one or more indications in a total of 40 countries and regions, including the United States, China, the European Union, Australia and Canada. To date, more than 20 marketing authorization applications have been submitted for BRUKINSA for various indications.

About Pamiparib

Pamiparib is an inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib was the first PARP inhibitor approved in both platinum-sensitive and platinum-resistant relapsed ovarian cancer in China. Pamiparib is currently being evaluated globally as a monotherapy or in combination with other agents for a variety of solid tumor malignancies.

In China, pamiparib received conditional approval for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy in May 2021. Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.

On December 2, 2021 Integra Therapeutics, a biotechnology company that is creating next-generation gene writing tools to boost the efficiency and safety of advanced therapies, reported the company has completed its first round of funding for €4.5 million with Advent France Biotechnology (France), Invivo Capital (Spain) and Takeda Ventures (USA) (Press release, Integra Therapeutics, DEC 2, 2021, View Source [SID1234654526]).

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Integra Tx was founded in late 2020 as a spin-off of Pompeu Fabra University (UPF) based on technology developed in the Translational Synthetic Biology Lab led by Dr Marc Güell (EMBO Young Investigator, National Research Award for Young Talent and co-founder of two biotech firms).

The great potential of this novel gene writing technology lies in the fact that it resolves some of the main technical limitations of gene therapy: it can be used to paste DNA sequences of any size gene with high precision. Advanced therapies are one of the pillars of the medicine of the future and are aimed at both preventing and treating genetic and oncological diseases that, for now, are incurable.

The funds raised in this round will allow Integra Tx to complete the prototype of the new gene writing technology platform, carry out preclinical validation using in vivo and ex vivo models, and manage its patent portfolio in 2022 and 2023. After that, the company plans to open a Series A round to seek regulatory approval and carry out clinical trials with patients.

"We’re very proud to be transferring our scientific knowledge and technological skills in gene editing from the lab to society. We thank all our investors for their commitment to Integra Tx and to making advanced therapies safer and more effective, and getting them to patients that urgently need them," says Dr Avencia Sánchez-Mejías, co-founder and CEO of Integra Tx. Sánchez-Mejías joined the UPF Translational Synthetic Biology Lab in 2018 after doing research at the Institute of Biomedicine of Seville, the National University of Singapore and the University of Miami Miller School of Medicine.

Dr Marc Güell, co-founder and CSO of Integra Tx, explains, "the Integra Tx technology platform is very promising because it is an evolution of the CRISPR-Cas techniques. We’ve found a way to merge them with transposase and integrase proteins that have a great capacity for gene transfer and to not depend on viral vectors for transporting the components into the cell, which is a step forward in making these therapies safer." Plus, it has applications both in vivo (directly in patients) and ex vivo (outside of patients).

Matthieu Coutet, Managing Partner at Advent France Biotechnology, adds: "We decided to invest in Integra Tx because we believe in its seasoned scientific and management team. Its founders have shown a strong passion and ambition to move Integra Tx’s technology forward, combined with a proven expertise in gene editing and advanced therapies."

Dr Luis Pareras, Managing Partner at Invivo Capital, says: "We’re thrilled with the possibilities Integra Tx’s plataform can develop to solve the problem of cargo size in gene therapy. We’re also very pleased with the international syndicate supporting this seed round, in yet another example of technology transfer opportunity and the competitiveness of the biotech ecosystem in Spain."

Miles Gerson, Takeda Ventures Partner and Senior Investment Director, says: "Takeda Ventures is very excited to support Integra Tx and their next generation gene writing platform with many potential applications to benefit patients."

On December 2, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that a poster presentation sharing new clinical data from the ongoing SRF617 Phase 1 trial will be presented at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO) 2021, to be held virtually from December 8 to 11, 2021 (Press release, Surface Oncology, DEC 2, 2021, View Source [SID1234596399]).

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The poster includes new data from the ongoing Phase 1 study of SRF617, an antibody targeting CD39, as both a monotherapy and in combination, in patients with advanced solid tumors. The full poster will be placed on Surface Oncology’s website following the presentation.

Details of Surface’s ESMO (Free ESMO Whitepaper)-IO poster presentation:

Title: First-in-human phase 1 trial of SRF617, a potent inhibitor of CD39 activity, as monotherapy or in combination, in patients with advanced solid tumors
Poster Number: 135P
Lead Author: Amita Patnaik, M.D.
Presentation Date and Time: On-demand e-Poster will be available on December 6, 2021 at 12:00 CET (6:00 a.m. ET)

On December 2, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly") (NYSE: LLY), reported that the innovative PD-1 inhibitor sintilimab has been successfully included in the updated National Reimbursement Drug List ("NRDL") for all approved indications, according to the latest announcement from the China National Healthcare Security Administration ("NHSA") (Press release, Innovent Biologics, DEC 2, 2021, View Source [SID1234596417]). The updated NRDL will officially take effect on January 1, 2022.

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A total of four approved indications for sintilimab are now included in the updated NRDL:

Three indications for sintilimab have been included in the NRDL for the first time, as follows: in combination with pemetrexed and platinum chemotherapy for the first-line treatment of advanced or recurrent nonsquamous non-small cell lung cancer (nsq NSCLC) without sensitizing EGFR mutations or ALK rearrangements; in combination with gemcitabine and platinum chemotherapy for the first-line treatment of advanced or recurrent squamous non-small cell lung cancer (sq NSCLC); and in combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC).
An indication for relapsed or refractory classic Hodgkin’s lymphoma (cHL) after two lines or later of systemic chemotherapy, which was first included in the NRDL in 2019, has been successfully renewed this year.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "Two years ago, sintilimab was the first and only PD-1 inhibitor included in the NRDL. This year, three additional first-line indications for sintilimab have been successfully included in the NRDL, further enhancing the accessibility of this anti-cancer drug and alleviating financial burden for Chinese patients and their families. We have witnessed the profound reform and rapid development of pharmaceutical industry in China, driven by the government’s commitment to continuously support innovation and emphasize a healthier and better life for the people of China. Innovent is honored to be a part of the Chinese government’s initiative to improve health, and are devoted to the deepening of the national health care reform. With our company’s mission ‘to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people,’ we hope to continue to work together with all relevant parties to improve drug affordability and accessibility, and contribute to the ‘Healthy China 2030’ initiative."

Julio Gay-Ger, President and General Manager, Lilly China, stated, "In recent years, China has continued to intensify medical insurance reform, giving strategic priority to safeguarding people’s health. As a multinational pharmaceutical company tied with China for over 100 years, Lilly always adheres to the philosophy of ‘In China, For China’, and actively participates in China’s health reform, especially in the drug supply system. The indication expansion of sintilimab in the National Reimbursement Drugs List (NRDL) can further reduce the burden of healthcare, enabling the patients to afford innovative drugs and have a higher quality of life through persistent treatment. Lilly will continue to keep a close eye on the major healthcare challenges in China in the future, and play an important role in the country’s ‘all-round and full-cycle health’ ecosystem, to support the accelerated implementation of the ‘Healthy China 2030’ initiatives."

Mr. Min Liu, Chief Commercial Officer of Innovent, stated, "Sintilimab is the only PD-1 inhibitor in China with four major indications (1L nsq NSCLC, 1L sq NSCLC, 1L HCC and cHL) approved and included in China’s NRDL. Particularly, lung cancer and liver cancer are two of the most prevalent tumor types in China, accounting for the first and third largest numbers of new cases each year – representing a large unmet medical need. We will proactively support the work of the government departments at all levels, cooperate with the implementation of medical insurance policies in all regions, and help relieve patients’ economic burden to a further extent, to allow this high-quality immunotherapy product to benefit more lives of Chinese patients and their families."

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an 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. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, 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 and included in the National Reimbursement Drug List (NRDL) for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma
Additionally, Innovent currently has two regulatory submissions under review in China for sintilimab, for the first-line treatment of esophageal squamous cell carcinoma, and the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Additionally, three clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy
Phase 3 study in combination with BYVASDA (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated nonsquamous NSCLC following EGFR-TKI treatment
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.