On March 27, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported 2022 annual results as of 31 December 2022 (Press release, InnoCare Pharma, MAR 27, 2023, View Source [SID1234629397]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "The company achieved high-quality development in various fields in 2022: rapid growth of orelabrutinib sales after its inclusion in the National Reimbursement Drug List (NRDL), oralabrutinib’s approval in Singapore marking the commercialization go international, successful listing on the STAR Board of the Shanghai Stock Exchange, approval of tafasitamab in combination with lenalidomide in Hong Kong and first prescription in Boao, and 13 innovative drugs entering clinical trials… The Company has achieved many milestones in the 1.0 development stage. We are accelerating our concerted efforts towards the goal of Company 2.0, committing to building a leading franchise in Hema-Oncology, competitive drug portfolio for autoimmune diseases and solid tumor, so as to launch more drugs on the market, driving a substantial revenue increase year by year."

Financial Highlights

The revenue reached about RMB625 million in 2022, including about RMB566 million from orelabrutinib, a year-on-year increase of 163.6%, mainly due to the continuous growth of orelabrutinib after its inclusion in the NRDL;
The research and development expenses reached RMB639 million in 2022. Excluding the impact of the upfront payment to Incyte last year, the R&D expenses increased by 29.0% year-on-year;
The cash and cash equivalents1 rose to RMB9.56 billion, an increase of 37.4% year on year in 2022, mainly due to the fund raised from the STAR Board listing;
The total assets expanded to RMB10.32 billion in 2022, an increase of 39.5% compared with 2021;
Adjusted loss for 2022 as illustrated under Non-HKFRSs2 Measure reached RMB 474 million.
1 Cash and cash equivalents refer to cash, bank balance, investments measured at fair value investments and interest receivable.
2 Non-HKFRSs: Excluding foreign exchange and share-based compensation impact.

Orelabrutinib for the treatment of Multiple Sclerosis (MS)

The 12-week interim analysis data of the MS global phase II trial has met the primary endpoint. Orelabrutinib significantly reduced disease activity in RMS patients. The primary objective of detecting significant reduction in cumulative number of new gadolinium (Gd) + T1 lesions at week 12 compared to placebo was met in all three active treatment groups in a dose-dependent manner. The 50 mg QD, 50 mg BID and 80 mg QD group showed the reduction of 70.1% (P=0.0238), 80.8% (P=0.0032) and 92.1%(P=0.0006) respectively, supporting further development.

Developing B-Cell and T-Cell Pathways in Autoimmune Diseases

The Company has fortified powerful discovery engine in the global frontier targets for the development of autoimmune therapeutics through B-cell and T-cell pathways for the purpose of providing the first-in-class or best-in-class treatments to the massive unmet clinical needs with a promising market potential in global and/or regional markets.

Orelabrutinib

Phase IIa trial for systemic lupus erythematosus (SLE) delivered positive results, initiated the Phase IIb trial for a larger population clinical trial;
Phase II clinical trial for the treatment of primary immune thrombocytopenia purpura (ITP) achieved proof-of-concept (PoC). The data from 22 patients with previous response to glucocorticoids (GC) or intravenous immunoglobulin (IVIG) were analyzed as a sub-group: 75.0% patients at the 50mg arm achieved the primary endpoint.
Phase II clinical trial for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) undergoing in China.
ICP-488

The single ascending doses (SAD) part, two cohorts of multiple ascending doses (MAD) have been completed. ICP-488 is developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel disease (IBD).
ICP-332

Developed for the treatment of various autoimmune disorders, the Company has completed the Phase I clinical trial of ICP-332. Based on the data of safety, PK/PD, and biomarkers with no significant decrease of platelet and hemoglobin, InnoCare initiated Phase II study in atopic dermatitis (AD).
Building A Leading Franchise in Hema-Oncology

With Orelabrutinib as a backbone therapy and the support of our abundant pipeline in hematology, such as Tafasitamab, ICP-248, ICP-490, ICP-B02 and potential future internal and external pipeline development, InnoCare aims to become a leading player in hematology in China and worldwide by covering multiple myeloma (MM), Non-Hodgkin Lymphoma (NHL), and Leukemia by single or combo therapy. A particular combination therapy toolkit is well designed and aims to position a full coverage of DLBCL.

Orelabrutinib (BTK inhibitor)

Orelabrutinib’s supplemental New Drug Application (sNDA) was under priority review by the China National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL). So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.
In the U.S., patient enrollment of a Phase II registrational trial for R/R Mantle Cell Lymphoma (MCL) was completed, and expect to submit NDA in 2024.
Orelabrutinib was approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with R/R MCL, which marks the commercialization of InnoCare go international.
Phase III registrational trial for the first-line treatment of Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) is conducted in China. Patient enrollment is expected to be completed this year.
Strengthen development in diffuse large B lymphoma (DLBCL)
A Phase III registrational study of orelabrutinib for the first-line treatment of MCD DLBCL was initiated.
The latest data of orelabrutinib in the treatment of DLBCL in a real-world analysis were released at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety profile among patients with MCD DLBCL.
A comprehensive tool-kit including orelabrutinib, tafasitamab, ICP-B02 and ICP-490 offers a unique position to treat all stages of DLBCL patients with combination therapies.
ICP-B04 (Tafasitamab)

The first prescription of tafasitamab in combination with lenalidomide was filed at the Ruijin Hainan Hospital at Bo’ao, who achieved complete response (CR) after 2 cycles of treatment;
The Company is advancing the registrational trial of tafasitamab in combination with lenalidomide, as well as the exploratory clinical trial of orelabrutinib in Combination with tafasitamab + lenalidomide in China;
Tafasitamab in combination with lenalidomide was approved by the Department of Health, the Hong Kong Special Administrative Region, China, which will benefit the DLBCL patients in greater bay area;
Tafasitamab has been included in the overseas Special Drug list of commercial insurance in more than 10 provinces and cities, which improves the access of DLBCL patients in these regions.
ICP-B02 (CM355)

ICP-B02 is a CD20xCD3 bispecific antibody. First patient for the treatment of lymphoma was dosed in January 2022 and Phase I dose escalation is progressing. So far, the almost complete B-cell depletion was observed in patients treated with low dose of ICP-B02. The IND application for ICP-B02 subcutaneous (SC) formulation was approved for clinical trial by the CDE in March 2023.
ICP-490

Novel targeted protein degrader ICP-490 has entered clinical trial in China for the treatment of R/R multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). ICP-490 is much more potent, which can overcome acquired resistance against earlier-generation of CRBN modulators.
ICP-248

First subject has been dosed in the clinical trials of BCL2 inhibitor ICP-248, which is developed to treat malignant hematological tumors such as NHL and acute lymphoblastic leukemia (ALL) as single drug or in combination with other drugs such as BTK inhibitor. ICP-248 is expected to have extraordinary blockbuster potential.
Building a competitive drug portfolio for solid tumor in China and worldwide

To benefit patients more, the Company strived to expanding the breadth of the pipeline covering solid tumors through the precision medicine philosophy and intend to provide the right medicine to the right patient at the right time. InnoCare believes the potential best-in-class molecules ICP-192 and ICP-723 will enable the Company to establish a solid initial presence in the field of solid tumor treatment.

ICP-192 (Gunagratinib)

In January 2023, the latest data of gunagratinib in patients with cholangiocarcinoma (CCA) was presented at 2023 ASCO (Free ASCO Whitepaper)-GI. Gunagratinib is safe and well-tolerated with high response rate (52.9%) compared to other approved FGFR inhibitors in previously treated patients with locally advanced or metastatic CCA harboring FGR2 gene fusions or rearrangements. Currently, patient enrollment for ICP-192 registrational trial in CCA is ongoing.
ICP-723 (Zurletrectinib)

Phase II dose expansion study is going with recommended phase II dose (RP2D) at 8 mg, 75% ORR observed in various types of solid tumors carrying NTRK fusion in different dosage. Based on the Proof-of-Concept (PoC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China.
The first adolescent patient (12 to 18 years old) has been dosed in clinical trial with ICP-723. This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent patients after showing good safety and efficacy in adult patients. The IND submission for additional pediatric population (<12 years old) was accepted by CDE in January 2023.
ICP-B05 (CM369)

The first subject has been dosed in the clinical trial of monoclonal antibody ICP-B05 targeting CCR8 jointly developed by InnoCare and Keymed Biosciences. As the potential first-in-class, the drug is developed as a monotherapy or combined with other therapies to treat advanced solid tumors, including lung cancer, digestive tract cancer, etc.
ICP-189

The clinical trials of Novel SHP2 allosteric inhibitor ICP-189 are conducted in China and the U.S., developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. As of 8 February 2023, dosage has been escalated up to 40 mg with no DLT observed and demonstrated favorable PK profile and long half-life. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in 20 mg dose cohort achieved confirmed PR.
Other Corporate Development

STAR Board Listing
On September 21, 2022, InnoCare got listed on the STAR Board of the Shanghai Stock Exchange. The listing on the STAR Board will further enhance InnoCare’s innovative advantages in blood tumors, solid tumors and autoimmune diseases, and contribute to achieving its strategic goal of benefiting global patients with its self-developed innovative drugs.
Manufacturing
Guangzhou: Guangzhou InnoCare has been approved for commercial production of orelabrutinib, and provided this innovative drug to patients in 30 provinces (autonomous regions and municipalities).
Beijing: InnoCare’s Beijing Innovative Drug Base has started construction for the R&D center and large molecule production facility, and is expected to be completed in 2025.
To know more about the detailed financial data and business update of InnoCare 2022 annual results, please log in View Source

Conference Call Information

InnoCare will host a conference call at 9:30 a.m. Beijing time in Chinese and at 8:00 p.m. Beijing time in English on March 28, 2023. Participants must register in advance of the conference call. Details are as follows:

For Chinese conference call, please register through the below link:
View Source

For English conference call, please register through the below link:
View Source

On March 27, 2023 BJ Bioscience, Inc. BJ Bioscience, a biotech company focusing on discovery and development of novel biologics for cancer immunotherapy, reported that it entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) (Press release, BJ Bioscience, MAR 27, 2023, View Source [SID1234629396]). The collaboration will allow for the evaluation of safety and efficacy of BJ-001, a tumor-targeting IL-15 fusion protein, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in an ongoing Phase 1 clinical trial.

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BJ Bioscience will evaluate BJ-001 plus KEYTRUDA as part of the company’s ongoing trial in patients with locally advanced/metastatic solid tumors. In this trial, BJ-001 is studied as monotherapy or in combination with KEYTRUDA, for safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.

In monotherapy dose escalation cohorts, BJ-001 has demonstrated tolerable safety profiles, favorable PK/PD profiles, and encouraging preliminary efficacy results.

"BJ Bioscience is excited to collaborate with MSD, one of the world’s leading multinational pharmaceutical companies," said Joe Zhang, MD, PhD, cofounder and CEO of BJ Bioscience. "Many consider KEYTRUDA to be one of the gold-standard medicines in the cancer immunotherapy arena. We believe BJ-001 may be a promising addition to this area. Our preclinical studies demonstrated that the combination of BJ-001 and an anti-PD-1 antibody was well-tolerated and showed promising early antitumor activity compared to either drug alone as monotherapy. With its tumor-targeting properties, we’re looking forward to evaluating BJ-001 in combination with KEYTRUDA as a potential new treatment option to benefit more cancer patients. This investigational combination is a key component of our BJ-001 development program."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About BJ-001
BJ-001 is a tumor-targeting IL-15 fusion protein, designed to expand and activate cancer-fighting natural killer (NK) cells and CD8+ T cells, and to have selected distribution in tumors with high integrin-expression. Preclinical data have demonstrated the ability of BJ-001 to accumulate in integrin-expressing tumors. Clinical data to date have shown Best-in-Class properties of BJ-001, including tolerable safety, dose-dependent and encouraging magnitude of stimulation and expansion of NK cells and CD8+ T cells with no impact on immunosuppressive regulatory T cells.

On March 27, 2023 Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique antibody-cell conjugation (ACC) technology to address gaps in cancer care, reported the upcoming poster presentation of new preclinical data for ACE2016, a gamma delta-2 T cell therapy designed to target EGFR expressing solid tumors (Press release, Acepodia, MAR 27, 2023, View Source [SID1234629395]). The company will present this data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Orlando, Florida, April 14-19, 2023.

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The poster presentation will showcase data demonstrating the in vitro and in vivo efficacy of ACE2016 against EGFR-expressing cancer cells which warrant investigation of potential clinical application in EGFR-expressing tumors.

Details on the presentation and session are provided below:

Presentation details

Presentation Title: ACE2016: an off-the-shelf EGFR-targeting γδ2 T cell therapy against EGFR-expressing solid tumors
Session Title: Late-Breaking Research: Immunology 1
Session Date and Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM
Location: Poster Section 35
Poster Board Number: 5
Abstract Presentation Number: LB089

"The poster presentation at this year’s AACR (Free AACR Whitepaper) is an exciting opportunity for Acepodia to showcase preclinical data for ACE2016 as a potential off-the-shelf cell therapy which exploits the ability of gamma delta T cells to recognize and engage solid tumors expressing EGFR by ACC technology unlocking multiple receptor signaling," said Sonny Hsiao, Ph.D., chief executive officer and co-founder of Acepodia. "We look forward to presenting the preclinical data in more details in the poster session at AACR (Free AACR Whitepaper), and to further evaluating this exciting modality for solid tumor patients."

About Gamma-Delta T Cells
Acepodia’s gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of off-the-shelf cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.

On March 27, 2023 On Target Laboratories, Inc., a privately held biotechnology company developing intraoperative molecular imaging (IMI) agents to target and illuminate cancer during surgery, reported publication of results from the ELUCIDATE Phase 3 Trial of CYTALUX (pafolacianine) injection for use of IMI for cancer in the lung (Press release, On Target Laboratories, MAR 27, 2023, View Source [SID1234629394]). The results were published in the peer-reviewed Journal of Thoracic and Cardiovascular Surgery. In December 2022, the U.S. Food and Drug Administration expanded the indication of CYTALUX after previously granting approval for ovarian cancer in 2021, making it the first and only targeted molecular imaging agent that intraoperatively illuminates lung and ovarian cancers in real-time during surgery.

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In the ELUCIDATE trial (n=112), patients with suspected or biopsy-confirmed cancer in the lung scheduled for lung resection were administered CYTALUX intravenously within 24 hours before surgery. The research article reports that, in patients randomized to receive IMI with CYTALUX, a clinically significant event (CSE) occurred in 53% of patients (N=53 out of 100, p < 0.0001).* CSEs included locating the primary lesion that the surgeon could not otherwise locate with conventional techniques in 19% of patients, discovery of one or more additional cancerous lesions which was previously unknown in 8% of patients, and identification of a close resection margin (10mm) in 38% of patients. Among additional cancerous lesions discovered with CYTALUX, 73% were outside the planned resection field. Overall, surgeons reported changing the scope of their surgical plan in 29% patients (22 increase, 7 decrease). No drug-related serious adverse events occurred.

"Identification of lesions during surgery can be challenging, especially if the lesions are small or deep below the surface of the lung," said Inderpal Sarkaria, MD, Thoracic Surgeon at the University of Pittsburgh Medical Center and lead author on the publication. "Our research confirmed that CYTALUX helps surgeons more easily visualize lesions and detect additional cancer at one of the most critical moments – during their operation."

"We’re thrilled that this trial contributed to CYTALUX being available as a first-in-class agent to aid thoracic surgeons in visualizing otherwise undetectable cancerous lesions in the lung," said Chris Barys, President, Chief Executive Officer and Board Member of On Target Laboratories. "We believe that the adjunctive use of CYTALUX during lung cancer surgery will add significant value to surgeons, helping them make decisions in real-time that potentially lead to removing more cancer from their patient and improving outcomes."

* N=53 out of 100 patients with cancer in the lung. CYTALUX USPI describes a clinically significant event rate of 24% (N=24 out of 100) based on localization of the primary lesion (N=19 out of 100, 19%) and identification of a synchronous cancerous lesions (N=8 out of 100, 8%).

About the ELUCIDATE Trial

The ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) trial was a Phase 3, multi-center, single dose, open label trial and included 12 sites across the United States. The clinical trial (NCT04241315) investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

On March 27, 2023 Merck reported that it has strengthened its Oncology franchise by regaining exclusive worldwide rights to develop, manufacture, and commercialize anti-programmed death ligand-1 (PD-L1) antibody BAVENCIO (avelumab) following the termination of their Alliance agreement with Pfizer (Press release, Merck & Co, MAR 27, 2023, View Source [SID1234629392]).

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"On behalf of Merck, I’d like to thank Pfizer for their partnership and collaboration over the last nine years, and for the role they have played in the success of BAVENCIO," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "Our joint efforts have delivered meaningful therapeutic value to patients around the world who are living with cancer. This has been an incredible journey for us, and thanks to Pfizer’s partnership we are now very well positioned to continue to deliver this therapy to patients in need."

"Our alliance with Merck allowed us to combine our complementary strengths to develop and launch BAVENCIO to help meet the needs of people with cancer globally," said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. "We are proud of our achievements together, including introducing BAVENCIO as an important treatment option for patients with metastatic Merkel cell carcinoma, locally advanced or metastatic urothelial carcinoma, and in combination with INLYTA for advanced renal cell carcinoma. We thank our colleagues at Merck for a tremendous partnership and wish them well in their future plans for BAVENCIO."

Reflecting a long-held interest of Merck, effective June 30, 2023, Merck, through its affiliate Ares Trading S.A., will take full control of the global commercialization of BAVENCIO. The current profit share will be replaced by a 15% royalty to Pfizer on net sales of BAVENCIO. Merck and Pfizer will continue to operationalize their respective ongoing clinical trials for BAVENCIO, and Merck will control all future research and development activities. As it is currently, product manufacturing and supply chain will remain solely with Merck, ensuring continuous and reliable access to BAVENCIO for patients.

"This is an excellent example of our focused leadership strategy in action, as we are now fully accountable to reinforce BAVENCIO’s position as a standard of care in advanced urothelial carcinoma for the benefit of patients in need, and as an important therapeutic option for appropriate patients with renal cell carcinoma and Merkel cell carcinoma," says Peter Guenter, Chief Executive Officer Healthcare at Merck. "With our late-stage pipeline, our broader Oncology portfolio, and now with full ownership of BAVENCIO, we look forward to demonstrating the strength of our Oncology Franchise as we amplify our efforts to deliver important innovation to patients."

BAVENCIO was discovered in-house at Merck. The Alliance between Merck and Pfizer was executed in 2014 to co-develop and co-commercialize BAVENCIO with the goal to accelerate development of the human anti PD-L1 antibody. With this announcement, Bavencio will further contribute to Merck’s Big 3 strategy focusing on new Healthcare products, Process Solutions and Life Science Services, as well as Semiconductor Solutions.

BAVENCIO is an anti PD-L1 monoclonal antibody that is widely recognized in international guidelines as the standard-of-care for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.1-3 In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

The European Commission (EC) has authorized the use of BAVENCIO as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized by the EC for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced RCC. Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients in 68 countries for at least one use.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.