June 14, 2024 - 🧬 [nGram] Today’s Oncology Scoop: FDA Approves Augtyro™, ASCO 2024 Highlights, and More

  1. FDA approves Augtyro for NTRK-positive solid tumors
    • The FDA has granted accelerated approval for Augtyro (repotrectinib) for treating adult and pediatric patients (12 years and older) with NTRK-positive locally advanced or metastatic solid tumors.
    • Approval is based on the Phase 1/2 TRIDENT-1 study, which showed significant overall response rates and duration of response in both TKI-naïve and TKI-pretreated patients.
    • In TKI-naïve patients, 58% had a confirmed objective response rate (cORR), with 43% experiencing partial responses and 15% complete responses.
    • In TKI-pretreated patients, the cORR was 50%, with all responses being partial.
    • Warnings and precautions include CNS effects, interstitial lung disease, hepatotoxicity, myalgia, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.
    • Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
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  2. Brenus Pharma presents first-in-human phase I/IIA trial of STC-1010 at ASCO 2024
    • Brenus Pharma presented the study design of the 'BreAK-CRC' trial for STC-1010 at the ASCO annual meeting.
    • The trial will be conducted in 9 oncology early phase centers across the EU and US.
    • STC-1010 is a next-generation cancer vaccine targeting metastatic colorectal cancer (mCRC).
    • The Phase I part of the trial will assess the tolerability of two dose levels of STC-1010 combined with low-dose immunostimulants and standard chemotherapy.
    • The Phase IIA part will focus on evaluating the treatment's efficacy, particularly the 12-month non-progression rate.
    • Exploratory analysis will evaluate the immune response and ctDNA dynamics.
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  3. Innovent delivers oral presentation on clinical data of IBI363 in advanced non-small cell lung cancer and other solid tumors at the 2024 ESMO virtual plenary
    • Innovent presented clinical data of IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2024 ESMO Virtual Plenary.
    • The Phase 1a/1b study evaluated the safety, tolerability, and preliminary efficacy of IBI363 in over 300 subjects with advanced solid tumors.
    • IBI363 demonstrated good tolerability and safety, with the most common treatment-related adverse events being arthralgia, anemia, hyperthyroidism, and hypothyroidism.
    • Efficacy results showed 3 complete responses and 49 partial responses among 300 subjects, with a dose-dependent efficacy observed at 3mg/kg.
    • Promising efficacy signals were noted in driver gene wild-type non-small cell lung cancer and IO-treated melanoma, with high response rates in IO-naïve mucosal melanoma.
    • The study will continue to explore the anti-tumor activity of IBI363 in NSCLC, melanoma, and other tumors, with future data updates expected at academic conferences or in journals.
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  4. LG Chem and AVEO Oncology announce first proprietary anti-cancer compound enters phase 1 clinical study
    • LG Chem and AVEO Oncology have initiated a Phase 1 clinical study for LB-LR1109, their first proprietary anti-cancer compound.
    • The study is a multi-center, open-label, non-randomized, dose escalation trial to determine the recommended Phase 2 dose.
    • Participants include patients with unresectable and metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma.
    • The trial aims to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamics of LB-LR1109.
    • Preclinical studies showed dose-dependent anti-cancer effects, leading to FDA approval for an Investigational New Drug application in December last year.
    • Next steps include advancing strategies for late-stage clinical development and regulatory approval.
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  5. Findings from landmark RESONATE-2 study confirm sustained survival benefit of ibrutinib for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up
    • RESONATE-2 study data presented at the 2024 European Hematology Association (EHA) Congress.
    • Ibrutinib showed a median progression-free survival (PFS) of 8.9 years versus 1.3 years for chlorambucil.
    • Significant PFS benefit observed across all subgroups, including high-risk genomic features.
    • At 10 years, 27% of patients remained on ibrutinib with a median treatment duration of 6.2 years.
    • No new safety signals emerged; adverse events were manageable with dose reductions.
    • Pooled analysis of three Phase 3 studies showed overall survival comparable to the general European population.
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  6. IN8bio presents positive data demonstrating durable 1-year complete remission in 100% of evaluable patients in phase 1 trial of INB-100
    • 100% of treated leukemia patients (n=10/10) achieved durable complete remission (CR) at 1-year.
    • Patients included high-risk and relapsed acute myeloid leukemia (AML) who had failed multiple lines of therapy.
    • Data showed long-term in vivo expansion and persistence of allogeneic gamma-delta T cells 365 days post-administration.
    • No dose limiting toxicities (DLTs), cytokine release syndrome (CRS), neurotoxicity, or serious infections were observed.
    • The trial has been expanded to enroll an additional ten patients at Dose Level 2 (DL2), with updated data expected in late 2024 and 2025.
    • IN8bio plans to discuss a potential registrational trial with the FDA in a Type B meeting this summer.
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  7. Syndax presents updated positive data from BEAT AML and AUGMENT-102 phase 1/2 combination trials of revumenib in patients with acute leukemias at EHA 2024 congress
    • Revumenib shows potential to enhance current standard of care agents.
    • BEAT AML trial: 96% CRc observed in newly diagnosed mNPM1 or KMT2Ar AML patients.
    • AUGMENT-102 trial: 52% CRc observed in relapsed/refractory mNPM1, NUP98r, or KMT2Ar acute leukemia patients.
    • BEAT AML trial: Revumenib combined with venetoclax/azacitidine showed a high rate of MRD-negative responses.
    • AUGMENT-102 trial: Revumenib combined with fludarabine/cytarabine was tolerable in heavily pretreated patients.
    • Next steps: Expansion cohort ongoing, pivotal trial initiation planned by year-end 2024.
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  8. Immune-Onc Therapeutics to present additional positive interim data from IO-202 Phase 1b expansion cohort in patients with chronic myelomonocytic leukemia (CMML) at 2024 European Hematology Association (EHA) Annual Congress
    • Immune-Onc Therapeutics will present additional positive interim Phase 1b data for IO-202 in CMML patients at the 2024 EHA Annual Meeting.
    • CMML is a rare hematologic malignancy with poor survival outcomes and no effective standard of care.
    • Promising early-cycle responses include a 53.8% complete remission (CR) rate in patients treated with IO-202 in combination with azacitidine (AZA).
    • The Phase 1b interim data demonstrate that IO-202 is well tolerated.
    • IO-202 has received Fast Track and Orphan Drug Designations from the FDA for the treatment of AML and CMML.
    • The company plans to continue collaborations with investigators and the FDA to conduct a registrational study in frontline CMML patients.
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  9. New Kite clinical research and real-world evidence for Yescarta demonstrate benefit from earlier lines of treatment
    • Kite presented results from three new analyses for Yescarta in relapsed/refractory large B-cell lymphoma (R/R LBCL) at the 2024 European Hematology Association Annual Congress.
    • A comparative analysis of real-world and clinical trial data showed a higher manufacturing success rate and improved T-cell performance for Yescarta in second-line versus third-line plus treatment of R/R LBCL.
    • The analysis found a 2.60% higher first-pass manufacturing success rate for second-line treatment, potentially reducing vein-to-vein times.
    • Patients treated in the second-line setting displayed approximately twice as many naïve-like T-cells compared to those treated in third-line plus settings.
    • Preliminary findings from the ZUMA-24 study suggest that outpatient administration of Yescarta is feasible with appropriate monitoring.
    • A real-world outpatient study reported that Yescarta and Tecartus can be administered without added toxicity.
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  10. Bio-Path Holdings presents data from ongoing phase 2 combination study of prexigebersen for treatment of acute myeloid leukemia at European Hematology Association Congress
    • Bio-Path Holdings presented interim results from its Phase 2 study of prexigebersen in combination with decitabine and venetoclax for AML treatment.
    • The presentation was made at the 2024 European Hematology Association Congress in Madrid, Spain.
    • In Cohort 1, 75% of evaluable newly diagnosed AML patients achieved complete or partial remission.
    • In Cohort 2, 55% of evaluable relapsed/refractory AML patients achieved complete or partial remission.
    • Adverse events were consistent with those expected from decitabine and venetoclax, including fatigue, anemia, and neutropenia.
    • Bio-Path plans to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively.
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