On December 11, 2023 Shanghai Yingli Pharmaceutical Co., Ltd. ("Yingli Pharma"), a biopharmaceutical company focused on developing oral therapies for cancer and metabolic diseases, reported the pivotal Phase 2 clinical trial results of the investigation of linperlisib in the treatment of patients with relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL) (Press release, Yingli Pharmaceutical, DEC 11, 2023, View Source [SID1234638458]). Linperlisib is a phosphoinositide 3-kinase delta (PI3Kδ) oral inhibitor, approved in China for treatment of patients with r/r follicular lymphoma after systemic therapy.

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"There is a vital need for new therapies to treat highly aggressive cancers such as r/r PTCL where there are very limited treatment options." said Dr. Jun Zhu, Professor, Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China, who was the leading investigator for this pivotal clinical trial. "In addition to the promising efficacy and well manageable safety of linperlisib in r/r PTCL, it is noteworthy that a high proportion of the treated patients were shown to have a complete response, and responses have been seen in all the major PTCL subtypes."

"Our approach is to develop novel oral agents that will allow patients to safely administer at home," said Michael Hui, CEO of Yingli Pharma, "We are delighted that the encouraging results of this study support the use of linperlisib in this hard-to-treat disease and are excited to continue developing linperlisib in more indications. The company has applied for linperlisib marketing approval in r/r PTCL in China based on these pivotal study findings." Mr. Hui added, "We look forward to the results of an ongoing open-label multi-center Phase 2 study in the U.S. and Italy in r/r PTCL and r/r CTCL."

Safe and effective treatment of r/r PTCL patients

The pivotal r/r PTCL Phase 2 clinical trial enrolled 98 patients (pts) from May 2021 to October 2022 at 25 clinical sites in China. The pts had a median of two lines of prior systemic therapies. Sixty-four pts (73%) had refractory disease, 59 pts (67%) had relapsed disease, and 35 pts (40%) had both relapsed and refractory diseases. All patients received linperlisib at 80 mg QD, the RP2D for the drug, with a minimum of 6 months follow-up.

The linperlisib-treated patients (Full Analysis Set N = 88) evaluated by Lugano criteria, had a 48% overall response rate, including 30% complete responses and 18% partial responses, as well as a 68% disease control rate. The median Duration of Response was not reached although the 6-month DOR rate was 75%. The median PFS was 5.5 months (95% CI, 3.5, 15.6) and the median OS was 14.2 months (95%CI, 7.9, not reached). Responses were observed across PTCL subtypes.

Linperlisib was well tolerated with a differentiated and manageable safety profile, specifically having very low levels of immune-mediated toxicities. In the linperlisib-treated patient safety dataset (N=98) for the pivotal study, the most common hematologic treatment related adverse events (TRAEs) of Grade≥3 were neutropenia (32%), leukocytopenia (10%), Anemia (6%), Thrombocytopenia (5%), and Lymphocytopenia (5%). The most common nonhematologic TRAEs of Grade≥3 were pneumonia (14%) and upper respiratory tract infection (5%). Immune-mediated Grade≥3 TRAEs including elevated ALT, AST, diarrhea, colitis, rash were not reported or were <5%. Nine patients (9.2%) discontinued from the study due to various adverse events. The safety results of this study were consistent with previously reported data in other linperlisib clinical studies.

About linperlisib

Linperlisib, a next-generation PI3K-selective oral inhibitor, received marketing approval in China in 2022 for treatment of patients with relapsed and/or refractory follicular lymphoma after two or more systemic therapies. Linperlisib also received U.S. FDA Orphan Drug Designations for follicular lymphoma, chronic lymphocytic leukemia, and T cell lymphomas.

Linperlisib is under investigation in multiple additional clinical trials as a monotherapy: frontline PTCL, r/r large granular T lymphocytic leukemia, r/r autoimmune hemolytic anemia; and in combination with other agents: in second line follicular lymphoma and marginal zone lymphoma, frontline PTCL, and r/r CTCL. In the U.S. and EU, linperlisib is being developed by 280Bio, Inc (San Francisco, CA., USA), a wholly-owned subsidiary of Yingli Pharma, in a Phase 2 clinical study in r/r T Cell Lymphomas [PTCL and CTCL].

On December 11, 2023 Sumitomo Pharma America, Inc. (SMPA) reported new data from the ongoing Phase 1/2 first-in-human study of DSP-5336, in patients with relapsed or refractory acute leukemia, presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Sumitomo Pharmaceuticals, DEC 11, 2023, View Source [SID1234638457]). DSP-5336 is an investigational small molecule inhibitor of the menin and mixed-lineage leukemia (MLL) protein interaction, which plays key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.1,2,3

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Data from the open-label, ongoing dose determination portion of the Phase 1/2 study enrolling patients with relapsed or refractory acute leukemia with relevant genomic alterations receiving oral DSP-5336 up to 200 mg twice-daily were presented at the meeting. In the ongoing study, patients are continuing to dose escalate and are now at therapeutic levels.

Preliminary results presented at ASH (Free ASH Whitepaper) 2023 included four evaluable patients treated with DSP-5336 200 mg twice-daily, three of whom showed objective responses. Clinical remission with partial hematologic recovery and clinical remission with incomplete count recovery (CRh/CRi) was achieved by one patient, CRi was achieved by one patient, and morphologic leukemia-free state (MLFS) was achieved by one patient. All patients cleared peripheral blasts. To date, DSP-5336 has been well-tolerated, notably, with no treatment-related cardiac effects, including QT prolongation. Additionally, differentiation syndrome has not been observed at the 200 mg twice-daily dose.

"While these data are early-stage, it is encouraging to see promising clinical activity from DSP-5336, particularly with limited safety signals and a clean tolerability profile to date," said Navel Daver, M.D., Director, Department of Leukemia, Division of Leukemia Research Alliance Program, The University of Texas MD Anderson Cancer Center and lead author on the DSP-5336 poster at ASH (Free ASH Whitepaper). "DSP-5336 is an investigational targeted therapy that inhibits menin-MLL protein interaction. Inhibition of the menin-MLL protein interaction may be able to reverse the leukemogenic activity of MLL fusion proteins and may be a future therapeutic option for acute leukemia."

Leukemia is a type of cancer that forms in blood-forming tissue, characterized by the uncontrolled growth of blood cells, usually white blood cells in the bone marrow.4 Acute leukemia, a form of leukemia, requires immediate treatment as blood cells multiply rapidly leading to a sudden onset of symptoms.4

"There is a high unmet need for new and innovative approaches in the treatment of relapsed or refractory acute leukemia, as many patients have limited options to treat the disease or do not respond to currently available cancer therapies," said Jatin Shah, M.D., Chief Oncology Development Officer, SMPA. "We believe we are close to determining the appropriate therapeutic dose of DSP-5336 in our ongoing study and were encouraged by our discussions on these results with the leading hematological oncology community at ASH (Free ASH Whitepaper). We look forward to continuing the study of DSP-5336 as a monotherapy and to exploring additional combination studies."

Additional SMPA data presented at ASH (Free ASH Whitepaper) included an oral presentation of encouraging preliminary results from the ongoing Phase 1/2 study of TP-3654 monotherapy in patients with relapsed or refractory myelofibrosis who were previously treated with or ineligible for a JAK inhibitor.

About DSP-5336
DSP-5336 is an investigational small molecule inhibitor of the menin and mixed-lineage leukemia (MLL) protein interaction. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.1,2 In preclinical studies, DSP-5336 has shown selective growth inhibition in human acute leukemia cell lines with KMT2A (MLL) rearrangements or NPM1 mutations.1,3 DSP-5336 showed induced reduction of gene expression of HOXA9 and MEIS1, which are highly expressing leukemia associate genes, and increased expression of differentiation marker gene CD11b in the human acute leukemia cell lines with MLL rearrangements.5,6 DSP-5336 also showed growth inhibition and changes of gene expression levels of HOXA9, MEIS1 and CD11b on human acute leukemia patient samples with MLL rearrangements or NPM1 mutations.5,6 The safety and efficacy of DSP-5336 is currently being clinically evaluated in a Phase 1/2 dose escalation/dose expansion study in patients with relapsed or refractory acute leukemia (NCT04988555). The FDA granted Orphan Drug Designation for DSP-5336 for the indication of acute myeloid leukemia in June 2022.

About TP-3654
TP-3654 is an oral investigational inhibitor of PIM1 kinase, which has shown potential antitumor and antifibrotic activity through multiple pathways, including induction of apoptosis in preclinical models.7,8 TP-3654 was observed to inhibit proliferation and induce apoptosis in murine and human hematopoietic cells expressing the clinically relevant JAK2V617F mutation.7 TP-3654 alone and in combination with ruxolitinib showed white blood cell and neutrophil count normalization, and also reduced spleen size and bone marrow fibrosis in JAK2V617F and MPLW515L murine models of myelofibrosis.8 The safety and efficacy of TP-3654 is currently being clinically evaluated in a Phase 1/2 study in patients with intermediate and high-risk myelofibrosis (NCT04176198). The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TP-3654 for the indication of myelofibrosis in May 2022.

On December 11, 2023 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, reported results from phase 1b/2 ELEVATE and ELECTRA clinical studies evaluating ORSERDU (elacestrant) in combination with other treatments (Press release, Menarini, DEC 11, 2023, View Source;metastatic-breast-cancer-mbc-at-the-2023-san-antonio-breast–302011539.html [SID1234638456]). Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options. Data was presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.

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The ELEVATE study is evaluating elacestrant in combination with inhibitors of the PI3K/AKT/mTOR pathway (everolimus and alpelisib) and cell-cycle pathway inhibitors (palbociclib, ribociclib, and abemaciclib). Results reported at SABCS 2023 include all combination data from Cohort 1 of the phase 1b portion of the study, with the therapies showing predictable safety profiles that were consistent with prior studies. Additional cohorts are currently under evaluation to assess pharmacokinetics (PK) and determine the recommended phase 2 dose (RP2D) for each combination. The full abstract (1576517) can be viewed here.

"It is encouraging to see positive initial safety results in various combination studies of ORSERDU, along with promising preliminary efficacy data in these trials," said Hope Rugo, MD, professor of medicine, Division of Hematology and Oncology at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. "We look forward to learning more about ORSERDU’s role in combination settings and its potential across the spectrum of metastatic breast cancer."

The ELECTRA study is evaluating elacestrant in combination with abemaciclib. Phase 1b of this study will also determine the recommended phase 2 dose (RP2D) of this combination in patients regardless of metastases sites. Phase 2 will evaluate the benefit of the combination in patients with ER+/HER2- advanced or metastatic breast cancer with brain metastases since both compounds have demonstrated the ability to cross the blood-brain barrier. Results reported at SABCS 2023 include the three dose cohorts of the phase 1b portion of the study, showing a tolerable and manageable safety profile with favorable preliminary efficacy in these patients, regardless of the site of their metastases. The three cohorts have been completed with no patients experiencing dose limiting toxicities. No discontinuations have been observed for any patient beyond the observation period due to toxicity. Most common adverse events were diarrhea, nausea, and neutropenia/neutrophil count decreased. Only neutropenia was associated with grade 3 events with the combination; managed with standard dose reduction for abemaciclib. The full abstract (1576518) can be viewed here.

"People living with ER+ metastatic breast cancer are often faced with treatment resistance, causing a significant need for innovative new options," said Elcin Barker Ergun, CEO of the Menarini Group. "While this data is preliminary, we are committed to advancing our comprehensive research on ORSERDU in combination with other treatments, to potentially help enhance patient outcomes, with the goal of extending and improving the lives of people with this disease."

See here for details of the Menarini Group/Stemline Therapeutics’ full range of presentations at SABCS.

About The Elacestrant Clinical Development Program
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial that will evaluate the safety and efficacy of elacestrant combined with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in these patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting. Elacestrant is also being evaluated in early breast cancer disease.

About ORSERDU (elacestrant)
U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Full prescribing information for the U.S. can be found at www.orserdu.com.

Important Safety Information
Warning and Precautions

Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose.

Adverse Reactions

Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
The most common adverse reactions (>10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite(15%), diarrhea(13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).

Drug interactions

Concomitant use with CYP3A4 Inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.

Use in specific populations

Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On December 11, 2023 IASO biotechnology ("IASO Bio"), a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, and 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, ophthalmology and other major diseases, reported the latest analysis results from the FUMANBA-1 study of Equecabtagene Autoleucel for the treatment of multiple myeloma in an oral presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, IASO Biotherapeutics, DEC 11, 2023, View Source [SID1234638454]). The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment.

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Oral Presentation Overview

Presentation Title: Efficacy Outcomes and Characteristics of Patients with Multiple Myeloma (MM) Who Achieved Sustained Minimal Residual Disease Negativity after Treatment with Equecabtagene Autoleucel (Eque-cel, CT103A) in Fumanba-1

Session Date and Time: Monday, December 11, 2023, 11:30 AM (San Diego)

Publication Number: 761

Presenter: Dr. Jue Wang, Associate Professor, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

The presentation is based on a post-hoc analysis of the FUMANBA-1 study. The FUMANBA-1 Study(Registration No.: NCT05066646) is a Phase Ib/II, single-arm, multicenter study to assess the efficacy and safety of the investigational drug Equecabtagene Autoleucel (IASO R&D code: CT103A, Innovent R&D code: IBI326), a fully human CAR-T cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM) who have received 3 or more lines of treatment.

As of December 31, 2022, with a median follow-up of 18.07 months, deep and sustained responses were observed in 103 evaluable patients. Among these patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%. Among subjects without prior CAR-T therapy, the ORR reached 98.9%, the sCR/CR rate reached 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%.

Minimal residual disease (MRD) negativity rate is 94.2% in the total evaluable patients, and all patients who achieved CR or above were MRD negative. The median time to achieve MRD negativity was 15 days, with 80.8% of patients remaining MRD negative at 12 months post infusion.

In addition, Equecabtagene Autoleucel could persist in the body for an extended period of time the median duration was 307.5 days. 12 months after infusion, 50% of patients had a vector copy number (VCN) above the lower limit of detection; and 24 months after infusion, VCN could still be detected in 40% of the patients.

Based on the descriptive analysis, patients receiving eque-cel achieved MRD negativity irrespective of cytogenetics status，extramedullary disease status，number of prior lines of therapy，and performance status. It suggests that eque-cel as immune cell therapy showed strong killing effect to myeloma cells without affecting by these factors.

In the FUMANBA-1 study, 90 RRMM patients without prior CAR-T therapy were evaluable for MRD test at 10-5. The results showed:

(1) An important prognostic factor for progression-free survival (PFS) in patients with RRMM treated with Equecabtagene Autoleucel is sustained MRD negativity: When comparing the PFS of patients in different MRD negative duration groups, those in the ≥ 6 months and ≥ 12 months group were significantly better than those in the < 6 months group. This was particularly true for those in the ≥ 12 months MRD negative duration group.

(2) There is a correlation between the persistence of CAR-T cells and sustainability of MRD negativity after infusion of Equecabtagene Autoleucel: Overall, there is a positive correlation between the two. This was particularly evident in subgroup analysis. The Triple-class exposure subgroup, the previous autologous transplantation treatment history subgroup, the high-risk cytogenetic abnormality subgroup, etc., showed a moderate to strong positive correlation between the persistence of CAR-T cells (VCN persistence) after infusion of Equecabtagene Autoleucel and the duration of MRD negativity. The correlation may become more significant in the future with longer term follow-up data, which could further reveal the positive correlation between long-term survival of CAR-T cells and long-term maintenance of MRD negativity.

"Studies have shown MRD is a biomarker that affects the long-term survival of RRMM patients. It’s necessary to maintain MRD negativity to improve the prognosis of RRMM patients and extend PFS. Equecabtagene Autoleucel has overcome two difficulties faced by traditional therapies in maintaining MRD negativity. First, it has increased the proportion of patients with MRD-negative persistence past 12 months from less than 10% to 80%. Second, only one-time infusion is needed to achieve sustainable MRD negativity. Traditional therapies require continuous medication to maintain MRD negativity, and once medication is stopped, patients face the risk of relapse. Patients who do not stop the medication will be facing the potential risk of inducing drug-resistant clones. Long-term medication and complex therapies increase direct treatment costs, seriously affect patients’ quality of life. The adverse effects caused by long term treatment also increase indirect costs to patients and their families. With its outstanding long-term persistence in the body, Equecabtagene Autoleucel can achieve lasting and deep remission in RRMM patients who have failed multiple lines of treatment. We expect that it will give more patients the hope of a cure," said principal investigators Professor Lu-gui Qiu, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Professor Chunrui Li, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

On December 11, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the Company will be presenting new data in second-line patients with advanced colorectal cancer from the DeFianCe study, a Phase 2 study evaluating DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place in San Francisco, CA and virtually on January 18-20, 2024 (Press release, Leap Therapeutics, DEC 11, 2023, View Source [SID1234638453]).

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Leap Presentation Details:

Title: DKN-01 plus bevacizumab and chemotherapy as second-line (2L) investigational therapy in advanced microsatellite stable (MSS) colorectal adenocarcinoma (CRC): DeFianCe trial
Presenter: Meredith Pelster, MD, MSc | Sarah Cannon Research Institute, Tennessee Oncology
Session Type: Poster Discussion Session
Session Title: Cancers of the Colon, Rectum, and Anus
Date and Time: Saturday, January 20, 2024, at 6:30 a.m. ET
Abstract Number: 104
Poster Session: Poster Session C

About the DeFianCe Study
The DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The Part A cohort enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. The study has expanded into a 130-patient Part B randomized controlled trial. The primary objective of the study is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival.