June 10, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Roche’s Alecensa Approved, TAGRISSO® Priority Review, Zymeworks in China


  1. European Commission approves Roche’s Alecensa for ALK-positive early-stage lung cancer
    • Alecensa approved as the first targeted adjuvant treatment for ALK-positive early-stage lung cancer.
    • Phase III ALINA study showed a 76% reduction in disease recurrence or death with Alecensa.
    • Approval addresses unmet need in early-stage lung cancer where recurrence rates are high post-surgery.
    • Alecensa demonstrated significant central nervous system disease-free survival benefits.
    • Safety and tolerability consistent with previous trials; no unexpected safety findings.
    • Following European approval, submissions to additional health authorities worldwide are ongoing.
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  2. Tagrisso granted priority review in the US for unresectable, stage III EGFR-mutated lung cancer
    • AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso has been accepted and granted Priority Review by the FDA.
    • The application is for the treatment of adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after chemoradiotherapy.
    • Tagrisso was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting.
    • The sNDA is based on data from the LAURA Phase III trial, which showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo.
    • The FDA action date for their regulatory decision is anticipated during the fourth quarter of 2024.
    • Tagrisso is already approved as monotherapy in more than 100 countries for various indications in EGFR-mutated NSCLC.
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  3. Zymeworks announces China NMPA acceptance of biologics license application for zanidatamab for second-line treatment of biliary tract cancer
    • The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has accepted the BLA for zanidatamab for second-line treatment of HER2-positive BTC.
    • Zymeworks is entitled to receive an $8 million milestone payment from BeiGene and remains eligible for up to $164 million in additional milestones plus royalties on product sales.
    • The BLA is based on data from the HERIZON-BTC-01 clinical trial, which showed a 41.3% objective response rate (ORR), 12.9 months median duration of response (DOR), and 5.5 months median progression-free survival (PFS).
    • Zanidatamab is an investigational HER2-targeted bispecific antibody with multiple mechanisms of action, including dual HER2 signal blockade and immune-mediated cytotoxicity.
    • The U.S. FDA has also accepted the BLA for zanidatamab for Priority Review with a target action date of November 29, 2024.
    • Zymeworks continues to advance zanidatamab in ongoing Phase 3 trials for first-line advanced or metastatic HER2-positive BTC and first-line HER2-positive gastroesophageal adenocarcinoma.
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  4. Can-Fite received IRB approval for the treatment of pancreatic cancer with Namodenoson in a Phase IIa study
    • Can-Fite BioPharma received IRB approval from Rabin Medical Center for a Phase IIa study of Namodenoson in pancreatic cancer.
    • The study is designed as an open-label trial to assess the safety and potential efficacy of Namodenoson in patients with advanced pancreatic adenocarcinoma.
    • Approximately 20 patients will receive oral Namodenoson 25 mg twice daily for 28-day cycles.
    • Primary objective: characterize the safety profile of Namodenoson.
    • Secondary objectives: evaluate clinical activity using ORR, PFS, DCR, DoR, and OS.
    • The study protocol has been submitted to the Ministry of Health for further approval.
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  5. MAIA Biotechnology's telomere targeting functionality is shown viable by FDA’s approval of a telomerase inhibitor agent therapy
    • MAIA Biotechnology announced the validation of telomere-targeting therapies following FDA approval of imetelstat for myelodysplastic syndromes.
    • Imetelstat, developed by Geron Corporation, targets low- to intermediate-risk hematologic malignancies.
    • MAIA's lead candidate, THIO, is in Phase 2 clinical development for high-risk non-small cell lung cancer (NSCLC).
    • THIO works by incorporating into telomeres in cancer cells, leading to rapid tumor cell death.
    • The Phase 2 trial, THIO-101, evaluates THIO’s anti-tumor activity when followed by PD-(L)1 inhibition.
    • For more information on the Phase 2 trial, visit ClinicalTrials.gov using the identifier NCT05208944.
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  6. Repare Therapeutics doses first patient in camonsertib monotherapy non-small cell lung cancer expansion of TRESR clinical trial
    • Repare Therapeutics has dosed the first patient in the camonsertib monotherapy NSCLC expansion of the TRESR clinical trial.
    • The TRESR trial is a multicenter, open-label, dose-escalation and expansion Phase 1/2 clinical trial.
    • The trial aims to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of camonsertib.
    • The NSCLC expansion will enroll up to 20 patients with ATR-inhibitor sensitizing mutations in NSCLC.
    • Camonsertib offers a promising oral therapy option with an established safety profile for recurrent NSCLC.
    • A potential data readout for the camonsertib monotherapy NSCLC expansion is expected in 2025.
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  7. J INTS BIO's JIN-A02 shows tumor reductions in phase 1 study
    • J INTS BIO presented an update on its Phase 1 clinical study of JIN-A02 at the 2024 ASCO Annual Meeting.
    • JIN-A02 is a 4th generation EGFR-TKI for NSCLC treatment, showing promising results in reducing tumor lesions.
    • Partial Response (PR) observed in two patients, with one showing a 28.6% reduction in brain metastasis.
    • No dose-limiting toxicity (DLT) or common side effects like rash, diarrhea, or cardiac toxicity reported so far.
    • The next cohort at 150mg daily is set to begin by the end of June.
    • JIN-A02 is expected to enter Phase 2 clinical trials by the end of this year.
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  8. Calyx / Invicro forges a strategic collaboration with BAMF Health
    • Calyx / Invicro partners with BAMF Health to accelerate clinical translation of radioligand therapies (RLT) and immuno-oncology (IO) agents.
    • The collaboration leverages GE HealthCare StarGuide™ SPECT/CT for precise quantitation and personalized care decisions.
    • Combines Calyx / Invicro's radiochemistry and imaging biomarker solutions with BAMF Health's advanced radiopharmacy facility.
    • A key project involves an actinium-225 initiative, with TerraPower supplying actinium-225 and BAMF using GE HealthCare StarGuide™ SPECT/CT.
    • Aims to streamline operations, enhance knowledge transfer, and provide access to the latest technologies from preclinical research to patient imaging.
    • Focuses on overcoming challenges in the clinical translation of RLT and IO treatments, ensuring faster access to promising therapies for patients.
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  9. Calidi Biotherapeutics collaborates with SIGA Technologies to advance RTNova virotherapy
    • Calidi Biotherapeutics has entered into a collaboration with SIGA Technologies to develop the RTNova (CLD-400) virotherapy platform.
    • The collaboration will focus on lung cancer and metastatic solid tumors, which are major causes of cancer deaths.
    • SIGA’s TPOXX will be tested as a safety switch to manage RTNova’s spread in vivo.
    • RTNova is designed to survive in the bloodstream, target multiple tumor sites, and kill tumor cells.
    • The FDA approved oral TPOXX in 2018 for smallpox treatment, and it has shown efficacy against orthopoxviruses in preclinical studies.
    • Next steps include further development and clinical trials to assess the safety and efficacy of the RTNova platform.
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