The American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, one of the most influential clinical oncology events in the world, was held in Chicago, USA from June 2-6. The ASCO annual meeting covers all oncology subspecialties, with more than 200 special sessions and more than 5,700 studies included, which is really a feast in the field of oncology!
Among them, four LBA studies were selected for the Plenary Session, covering lung cancer, brain tumor and Hodgkin's lymphoma, and the results of these studies are expected to rewrite the treatment pattern of each field.
Schweizer: vorasidenib significantly improves progression-free survival time
At the ASCO Annual Meeting, Schweizer presented the results of the clinical study INDIGO, a global, randomized, double-blind, Phase 3 study comparing vorasidenib (VOR) versus placebo (PBO) in patients with residual or recurrent grade 2 gliomas with IDH1/2 (isocitrate dehydrogenase 1 or 2) mutations.
Vorasidenib, an oral dual inhibitor of mutant (m)IDH1/2 enzymes with brain penetration developed by Schweizer, demonstrated a tolerable safety profile and preliminary clinical activity in the Phase 1 study.
The industry has described Vorasidenib as the first "game changer" in 20 years for patients with IDH-mutated grade 2 gliomas
Grade 2 glioma a slowly progressive malignant brain tumor with a poor long-term prognosis. Current treatments include observation after surgery, adjuvant radiotherapy, and chemotherapy, but none are radical and may be associated with short-term or long-term toxicity.
INDIGO is the first prospective, randomized phase 3 study of grade 2 mIDH glioma. The results of the study showed that VOR significantly improved progression-free survival time compared to placebo and demonstrated a manageable safety profile. Patients had delayed chemotherapy and radiotherapy, data that demonstrate that VOR has shown clinical benefit in this patient population.
PROSPECT: Providing an alternative treatment option for locally advanced rectal cancer
The plenary session also included the results of a clinical study for locally advanced rectal cancer (LARC) from PROSPECT (study code).
Radiotherapy combined with sensitized fluorouracil (5FUCRT) is the standard radical treatment for locally advanced rectal cancer. It improves disease-free survival (DFS) by reducing pelvic recurrence, but has short- and long-term toxicity.
The PROSPECT trial compared the effects of FOLFOX chemotherapy combined with selective use of 5FUCRT (intervention group) and 5FUCRT (control group) for neoadjuvant treatment before total rectal mesenteric excision (TME) for locally advanced rectal cancer. Patients were randomly assigned in a 1:1 ratio and were not blinded. Control patients received 5040 cGy of 5FUCRT over 5.5 weeks with concurrent capecitabine or 5FU.
The results of the study demonstrate the efficacy of FOLFOX chemotherapy combined with selective use of 5FUCRT for neoadjuvant treatment of locally advanced rectal cancer prior to low anterior rectal resection with TME. It provides patients and physicians with an alternative treatment option for locally advanced rectal cancer.
AstraZeneca: Ocetinib achieves unprecedented survival benefit in early-stage EGFR-mutated lung cancer
AstraZeneca announced positive results from the ADAURA Phase III clinical study at the ASCO Annual Meeting.
ADAURA is an overall survival analysis study of ocitinib adjuvant therapy in patients with resectable EGFR mutation (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC), and ADAURA is the first phase III study in the world to demonstrate a statistically significant DFS and OS benefit from targeted therapy in patients with EGFRm stage IB-IIIA NSCLC.
Ocitinib is a third-generation EGFR-TKI inhibitor developed by AstraZeneca with central nervous system (CNS) activity that potently and selectively inhibits EGFR-TKI sensitization and EGFR T790M-resistant mutations.
Patients were randomly assigned in a 1:1 ratio to the ocitinib 80 mg once-daily or placebo administration arm until disease relapse, end of treatment (3 years), or discontinuation criteria were met.
Ocitinib reduced the risk of death by 51% in the entire patient population in the study compared to the placebo control group. The OS data maturity was 21% (HR, 0.49; 95.03% CI, 0.33-0.73; p=0.0004) for the study's primary population (stage II-IIIA) and 18% (HR, 0.49; 95.03% CI, 0.34-0.70; p< 0.0001).
In adjuvant therapy, axitinib reduced the risk of patient death by more than half, further establishing this transformative agent as a cornerstone of lung cancer treatment for EGFR mutations. This result also underscores the importance of EGFR genetic testing in patients diagnosed with early-stage lung cancer and of treatment with ositinib in all patients with EGFR gene mutations.
Bristol-Myers Squibb/Takeda: PD-1 monoclonal antibody in combination with chemotherapy offers new options
This ASCO Annual Meeting announced a randomized study in advanced classic Hodgkin's lymphoma (AS HL) - SWOG S1826, a comparative evaluation study on nabritumomab-AVD (N-AVD) versus vibrituximab-AVD (BV-AVD).
Navulizumab is a PD-1 inhibitor developed by Bristol-Myers Squibb, also known as the big-name O drug (Opdivo). Vibutuximab, on the other hand, is an antibody-coupled drug (ADC) drug developed by Takeda that targets CD30.
PD-1 pathway is a key factor in the pathogenesis of Hodgkin's lymphoma, and blocking PD-1 is an effective treatment idea for relapsed/refractory Hodgkin's lymphoma. And CD30 is an excellent therapeutic target for classic Hodgkin's lymphoma.
S1826 is the largest study of classic Hodgkin's lymphoma in the history of the NCTN and is a key step in coordinating pediatric and adult treatment of AS HL. The study was funded by National Cancer Institute U10CA180888 and U10CA180819 of the National Institutes of Health and Bristol-Myers Squibb.
Data from the study showed that N-AVD significantly improved PFS in patients with AS HL compared to BV-AVD, significantly reduced patients' risk of cancer progression or death by 52%, 94% of patients remained alive and did not experience disease progression at one year (vs 86%), and immunologic adverse events were rare.
Conclusion
Among the four LBAs presented at the plenary session, whether it is oseltinib breaking the survival bottleneck in early-stage lung cancer or vorasidenib more than doubling PFS to open the era of precision therapy for glioma, or PD-1 monoclonal antibody combined with chemotherapy to bring a new highly effective and low-toxic regimen for Hodgkin's lymphoma, they are all great news for cancer treatment, and we look forward to more breakthroughs in the future to bring more benefits to cancer patients worldwide.