On January 21, 2022 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) the final clinical outcome and biomarker analysis of the open label, phase Ib study (NCT04072679) of sintilimab plus bevacizumab biosimilar injection for advanced hepatocellular carcinoma at the 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (Abstract# 455) (Press release, Innovent Biologics, JAN 21, 2022, View Source [SID1234606691]).

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The study, which was conducted in China, evaluated the treatment of sintilimab plus bevacizumab biosimilar injection for patients with local advanced or metastatic HCC with or without previous systemic treatment or systemic treatment failure. The Phase Ib study included dose escalation and dose expansion stages. In the dose escalation stage, patients were randomly assigned to receive sintilimab 200mg plus bevacizumab biosimilar 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group). In the dose expansion stage safety and efficacy were assessed for each dose group. A total of fifty patients were enrolled in final analysis, with 29 patients administered bevacizumab biosimilar 7.5 mg/kg and 21 patients 15 mg/kg. The safety profile was consistent with that observed in previously reported studies of sintilimab and bevacizumab biosimilar, without new or unexpected safety signals. The most common treatment-related adverse events (TRAE) were as hypertension (32%), proteinuria (26%) and fever (26%). The incidence of grade ≥ 3 adverse events in the high-dose group was 28.6%, while 13.8% in the low-dose group.

The overall response rate (ORR) was 34% (17/50) and ORRs for the low-dose and high-dose groups were 31% and 38%, respectively. The disease control rate (DCR) was 78% (39/50). Median progression-free survival (PFS) was 10.5 months (95%CI, 8.4-12.7) and median overall survival (OS) was 20.2 months (95%CI, 16.1 -24.3). Further biomarker analysis showed that patients with a high level of CD137 ≥ 31.8 pg/mL have longer PFS (mPFS:14.2 vs. 4.1months, p=0.001) and OS (mOS: NR vs.15.6months, p=0.023). In addition, the Tumor immune Microenvironment（TiME）analysis demonstrated that the high density of M1 macrophages (CD68+, CD163-) in stroma was related to higher efficacy (p=0.033), longer PFS (p=0. 024) and OS (p =0.046).

Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences stated: "This study not only showed the safety and efficacy data for sintilimab in combination with different doses of bevacizumab, but also identified biomarkers that could predict the efficacy of the combined treatment regimen for hepatocellular carcinoma, which lays the groundwork for more individualized treatment."

Dr. Zhou Hui, Senior Vice President of Innovent Biologics, stated: "Sintilimab plus bevacizumab biosimilar was approved for advanced hepatocellular carcinoma by National Medical Products Administration (NMPA) and successfully included in the National Reimbursement Drug List (NRDL) in 2021. This study showed the clinical data of sintilimab in combination with two different doses of bevacizumab biosimilar, potentially offering more treatment options for physicians. Meanwhile, the exploration of biomarkers for predicting hepatocellular carcinoma immunotherapy will contribute to better treatment options and represent a step towards precise and individualized treatment."

Dr. Li WANG , Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs commented that: "Lilly and Innovent are committed to bringing innovative oncology medicines with global quality to serve patients in China. The clinical outcome and biomarker analysis result in this phase Ib study of sintilimab plus bevacizumab biosimilar injection for advanced hepatocellular carcinoma provides more solid basis for individualized and precise treatment. The advancement of HCC treatment may contribute to the government’s goal of increasing the overall 5-year cancer survival rate by 15% by 2030, and also supports accelerating the implementation of the ‘Health China 2030’ initiative. In the future, we will continue to strengthen cooperation with Innovent to endeavor to bring additional treatment options to patients."

About NCT04072679 study

NCT04072679 study is a Phase 1b study assessing the safety, tolerability and anti-tumor activity of sintilimab in combination with bevacizumab biosimilar in subjects with local advanced or metastatic HCC with or without previous systemic treatment or systemic treatment failure in China. The study has two stages, the first is a dose escalation stage and the second is a dose expansion stage. In the dose escalation stage, subjects will receive either 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group) of bevacizumab biosimilar (IBI305) in combination with a fixed dose of 200 mg of sintilimab, respectively, and then entered into the dose expansion stage.

About Hepatocellular Carcinoma

Primary liver cancer (PLC) is a common malignancy of the digestive system worldwide, among which about half new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), accounting for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma (ICC) and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.

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 non-squamous 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 bevacizumab biosimilar for the first-line treatment of unresectable or advanced hepatocellular carcinoma.
Additionally, sintilimab currently has three regulatory submissions accepted for review in NMPA, including:
In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two 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.
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 non-squamous non-small cell lung cancer.

About BYVASDA (bevacizumab biosimilar injection)

BYVASDA, also known as IBI305, is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since its launch, bevacizumab has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab in these tumor types have been well recognized worldwide.

In China, BYVASDA (bevacizumab biosimilar injection) is approved for indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, and advanced or unresectable hepatocellular carcinoma.

On January 21, 2022 Medivir AB (Nasdaq Stockholm: MVIR-B) reported that an e-poster entitled "Liver biopsy biomarkers in a phase 1 study of the prodrug MIV-818 demonstrates proof-of-concept for cancer in the liver" will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit 3-4 February (Press release, Medivir, JAN 21, 2022, View Source [SID1234606692]). The Abstract (PO-221) is available on the EASL website (View Source).

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About fostroxacitabine bralpamide
Fostroxacitabine bralpamide (also named MIV-818) is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostroxacitabine bralpamide has completed a phase 1b monotherapy study, and a combination study in HCC was recently initiated.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On January 20, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that new efficacy and safety data from the first line (cohort A) of the phase 1b/2 DEDUCTIVE study of FOTIVDA (tivozanib) in combination with IMFINZI (durvalumab) in previously untreated metastatic hepatocellular carcinoma (HCC) are being presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium (Press release, AVEO, JAN 20, 2022, View Source [SID1234605615]). In addition, two trials in progress posters are being presented, which showcases cohort B of the DEDUCTIVE HCC study that is currently enrolling HCC patients following prior bevacizumab and atezolizumab; and the Company, in collaboration with the University of Florida Health Cancer Center, is presenting the study design for the Phase 1b/2 IMMCO-1 trial of atezolizumab plus tivozanib in immunologically cold pancreatic, gallbladder and biliary cancers.

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"We believe that the safety and efficacy data observed in cohort A of the Phase 2 portion of the DEDUCTIVE study continue to support the development of tivozanib to serve as an attractive VEGFR TKI to use in combination with durvalumab in first line HCC patients," said Michael Bailey, President and Chief Executive Officer of AVEO. "The poster presentations at this year’s ASCO (Free ASCO Whitepaper) GI conference reflect the expanding scope of our pipeline as we leverage the potential efficacy of our lead program tivozanib through a combination strategy targeting a number of cancers."

Topline Efficacy and Safety Data Poster Title: A Phase 1b/2 Study of Tivozanib in Combination with Durvalumab in Subjects with Advanced Hepatocellular Carcinoma (DEDUCTIVE): Efficacy Results in Previously Untreated Patients (Abstract #462 / Poster: M10)

The Company will present topline data for cohort A of the DEDUCTIVE study, which is assessing the safety and efficacy of tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with unresectable locally advanced or metastatic, previously untreated HCC. A total of 20 patients with advanced or metastatic HCC were enrolled in cohort A of the Phase 2 portion of the study safety and efficacy of tivozanib plus durvalumab. Patients received 0.89 mg of tivozanib orally once daily for 21 days followed by seven days off therapy in combination with 1500 mg of durvalumab intravenously (IV) on day one given every four weeks, on a 28 day cycle. The combination was well tolerated, with three patients showing Grade 3 TRAEs, and no Grade 4 TRAEs or treatment-related deaths. The combination demonstrated a 27.8% partial response (PR) rate and disease control rate (PR + stable disease) 67.8%, with a median PFS of 7.3 months and a 1-year OS of 76%, which positions the tivozanib combination well relative to other VEGF ICI combinations in the setting.

Trials in Progress Poster Presentation titled: A Phase 1b/2 Open Label Study of Tivozanib in Combination with Durvalumab in Subjects with Advanced Hepatocellular Carcinoma: DEDUCTIVE – (Abstract: TPS499 / Poster: Online Only)

The DEDUCTIVE study is a multicenter, open-label study to evaluate the safety, tolerability, and efficacy of tivozanib in combination with durvalumab in subjects with advanced HCC previously untreated (cohort A) or bevacizumab- and atezolizumab-pretreated HCC (cohort B). Cohort A is fully enrolled and cohort B will enroll up to 20 subjects. Cohort A showed a promising safety and efficacy profile in previously untreated patients and cohort B has the potential demonstrate the first clinical study results in the emerging population of prior bevacizumab and atezolizumab treated patients.

The rationale for a combination therapy of tivozanib plus durvalumab to treat HCC draws on the potential synergistic mechanisms of tivozanib and durvalumab to remove inhibition of the immune response that mediates antitumor activity. The selectivity and favorable tolerability of the VEGFR TKI tivozanib may allow it to be used as a combination therapy with an immune checkpoint inhibitor, such as durvalumab.

The DEDUCTIVE trial is being conducted as part of a clinical collaboration between AVEO and AstraZeneca. AVEO is serving as the study sponsor.

Trials in Progress Poster Presentation titled: A phase 1b/2 study (IMMCO-1) of atezolizumab plus tivozanib in immunologically cold pancreatic, gallbladder, and biliary cancers – (Abstract: TPS491 / Poster: N8)

The ongoing IMMCO-1 study is an open-label, non-randomized Phase 1b/2 signal seeking basket study of the combination of the tivozanib and atezolizumab in multiple immunologically cold tumors, including pancreatic, gallbladder and biliary cancers. The co-primary endpoints are safety and efficacy. The Phase 1b portion will assess the safety profile of the combination of tivozanib and atezolizumab with a potential dose de-escalation of tivozanib using a 3+3 study design to yield a recommended Phase 2 dose.

VEGF is thought to play a key role in modulating the anti-tumor immune response. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade. Combined use of a VEGF tyrosine kinase inhibitor (TKI) and checkpoint inhibitor is already standard of care in advanced kidney, cervical and endometrial cancers. There has been suggestion that such a combination may have clinical activity in some microsatellite stable (MSS) GI malignancies.

The Phase 2 portion is expected to enroll up to 26 additional patients using the recommended Phase 2 dose using the Simon two-stage design of recruitment. This signal seeking study is looking to confirm the best objective response rate for evaluable patients increasing from < 7% (null hypothesis) to 25% (one-sided alpha = 0.05; 80% power).

The three posters to be presented at the 2022 ASCO (Free ASCO Whitepaper) GI Cancers Symposium are available on the Publications page of the AVEO Oncology website (click here). Details on the presentation are available on the 2022 ASCO (Free ASCO Whitepaper) GI website (click here).

About FOTIVDA (tivozanib)

FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.2 FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.

On January 20, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported an enrollment update on the phase 1/2 GOBLET study in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) (Press release, Oncolytics Biotech, JAN 20, 2022, View Source [SID1234605634]).

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The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes three-patient safety run-ins for two of its four cohorts (first-line metastatic pancreatic and third-line metastatic colorectal cancer). Enrollment in these safety run-ins is complete. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

"There is a pressing unmet need for agents that can synergize with immune checkpoint inhibitors (ICI) in gastrointestinal (GI) cancers, as fewer than half of these patients respond to ICI monotherapy," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "These low response rates are driven by immunosuppressive tumor microenvironments, which pelareorep has been shown to reverse in prior clinical studies in GI, breast, and hematological cancers. We thus believe pelareorep can increase the proportion of GI cancer patients responding to checkpoint inhibitors and are seeking to validate this hypothesis in the GOBLET study. We are very pleased with the trial’s progress to date and look forward to its continued advancement."

The GOBLET study builds on previously reported clinical proof-of-concept data for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the study also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success.

A copy of the ASCO (Free ASCO Whitepaper)-GI poster titled, "GOBLET: A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab," will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 20211. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer2 and 9,090 new cases of anal cancer3 in the U.S.

On January 20, 2022 Veeva Systems (NYSE: VEEV) reported that the Lymphoma Academic Research Organization (LYSARC) selected Veeva Development Cloud to improve operational efficiency across its lymphoma therapy research (Press release, LYSA Lymphoma, JAN 20, 2022, View Source [SID1234605648]). LYSARC will use applications in Vault Clinical, Vault Quality, and Vault Safety suites to build a robust, connected technology foundation that enables faster execution, higher quality data, and better trial oversight.

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"Partnering with Veeva will accelerate our digital transformation for greater scalability and speed in our pursuit to develop innovative lymphoma therapies or improve current therapies," said Franck Morschhauser, president of LYSARC. "Using Veeva Development Cloud gives us a single connected platform that can free our staff from time-consuming tasks and allow them to focus on what drives us every day: scientific excellence for the benefit of lymphoma patients."

The largest European academic organization devoted to lymphoma clinical research, LYSARC recruits more than 750 patients every year across Belgium, France, and Portugal. To expand its reach, the organization is collaborating with other academic groups in Europe or abroad, in partnership with pharma companies, and needed technology that can scale with its growth.

Veeva Development Cloud will bring together clinical, quality, and safety operations for end-to-end business processes and execution. With a digital and unified systems landscape, LYSARC can improve the patient trial experience, ensure alignment with SOPs across stakeholders, and reduce the costs and lead times of clinical trials.

"LYSARC is fully invested in empowering its teams with advanced technologies to evolve how they work together in a complex environment," said Jim Reilly, vice president of Vault R&D and Quality at Veeva Systems. "We’re proud to work with an organization dedicated to innovation, and we look forward to supporting their development of new lymphoma research and therapies."

LYSARC, the operational structure of the cooperative group LYSA, is standardizing clinical processes with Vault CDMS, Vault CTMS, Vault eTMF, Vault Study Start-up, and Vault Payments, streamlining quality processes with Vault QMS, Vault QualityDocs, and Vault Training, and mitigating risk with Vault Safety. The organization will also encourage its network of partners to adopt Veeva SiteVault Free to enable seamless information sharing with site investigators and sponsors.

Additional Information
For more on Veeva Vault Development Cloud, visit: veeva.com/DevelopmentCloud Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems Follow @veevasystems on Twitter: twitter.com/veevasystems