RYBREVANT plus chemotherapy shows positive overall survival trend in EGFR-mutated lung cancer
- Phase 3 MARIPOSA-2 study shows RYBREVANT plus chemotherapy improves overall survival in previously treated NSCLC patients with EGFR mutations.
- At 18 months, 50% of patients on RYBREVANT plus chemotherapy were alive compared to 40% on chemotherapy alone.
- Significant improvements in treatment discontinuation rates and time to subsequent therapy were observed with RYBREVANT combination.
- RYBREVANT plus chemotherapy received European Commission approval in August 2024 for previously treated NSCLC with common EGFR mutations.
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IO Biotech announces positive results from phase 2 trial of IO102-IO103 in the first-line treatment of advanced head and neck cancer
- Phase 2 trial of IO102-IO103 in combination with pembrolizumab shows promising results in advanced head and neck cancer.
- Primary endpoint achieved with a 44.4% overall response rate (ORR) in PD-L1 high population.
- Encouraging median progression-free survival (PFS) of 6.6 months and a 66.7% disease control rate (DCR).
- No new safety signals observed; safety profile consistent with previous data.
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iTeos announces clinically meaningful objective response rate in GALAXIES Lung-201 study
- Clinically meaningful ORR of 63.3-76.7% observed with belrestotug + dostarlimab combinations.
- Confirmed ORR (cORR) at ~60% for every dose, with a >30% cORR difference compared to dostarlimab monotherapy.
- Safety profile consistent with known checkpoint inhibitor combinations.
- GALAXIES Lung-301, a global Phase 3 registration study, is currently enrolling in the same indication and setting.
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Instil Bio and ImmuneOnco announce global registrational strategy for PD-L1xVEGF bispecific antibody in NSCLC and TNBC
- Global registrational strategy for SYN-2510/IMM2510 in first-line non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
- Phase 1b/2 chemo combination study in first-line NSCLC to start in late 2024 in China.
- Phase 1b/2 chemo combination study in first-line TNBC to start in early 2025 in China.
- US IND submission for SYN-2510 targeted for late 2024, with a Phase 2 trial in second-line NSCLC.
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Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer
- The CONTACT-02 trial investigated Cabometyx (cabozantinib) in combination with atezolizumab in metastatic castration-resistant prostate cancer (mCRPC).
- The trial showed a positive trend towards improvement in overall survival (OS) but did not meet statistical significance.
- Ipsen will not pursue regulatory submissions for the combination regimen outside the US and Japan.
- The trial met the primary endpoint of progression-free survival (PFS) with a statistically significant benefit.
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Keytruda plus chemotherapy reduces death risk in high-risk early-stage TNBC
- Merck's Phase 3 KEYNOTE-522 trial shows Keytruda plus chemotherapy before surgery and continued as a single agent after surgery reduces death risk by 34% in high-risk early-stage triple-negative breast cancer (TNBC).
- After a median follow-up of 75.1 months, the five-year overall survival (OS) rate was 86.6% for the Keytruda regimen versus 81.7% for the chemotherapy-placebo regimen.
- The trial enrolled 1,174 patients, with the Keytruda regimen showing consistent benefits across various subgroups, including those defined by PD-L1 expression, tumor size, and nodal status.
- Keytruda is the first immunotherapy-based regimen to show a significant OS improvement in this patient population, supporting regulatory approvals in the U.S., Europe, Japan, and other countries.
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IMFINZI plus IMJUDO shows unprecedented survival in advanced liver cancer
- HIMALAYA Phase III trial results show IMFINZI plus IMJUDO significantly improves overall survival in advanced liver cancer.
- At five years, 19.6% of patients treated with the STRIDE regimen were alive compared to 9.4% with sorafenib.
- The STRIDE regimen reduced the risk of death by 24% compared to sorafenib.
- IMFINZI in combination with IMJUDO is approved for advanced or unresectable HCC in multiple countries.
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Phase III ARANOTE trial shows NUBEQA significantly reduced risk of radiological progression or death in metastatic hormone-sensitive prostate cancer
- The Phase III ARANOTE trial demonstrated that NUBEQA (darolutamide) plus ADT significantly improved radiological progression-free survival (rPFS) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
- The trial involved 669 patients randomized 2:1 to receive either 600 mg of NUBEQA or placebo twice daily in addition to ADT.
- Results showed a 40% risk reduction in high-volume mHSPC and a 70% risk reduction in low-volume disease.
- Bayer plans to submit the ARANOTE trial data to the FDA to support the expanded use of NUBEQA in mHSPC patients.
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Immunocore presents Phase 1 data of brenetafusp in ovarian cancer
- Immunocore presented Phase 1 data of brenetafusp at the 2024 ESMO Congress.
- Brenetafusp showed clinical activity as monotherapy and in combination with chemotherapy in heavily pre-treated, platinum-resistant ovarian cancer patients.
- In the monotherapy group, 58% of patients demonstrated disease control, with a median progression-free survival of 3.3 months.
- In the combination therapy group, 69% of patients achieved disease control, with a molecular response rate of 82%.
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Avacta reports updated phase 1 clinical data of AVA6000 at ESMO congress
- AVA6000 is safe and well-tolerated in both every three weeks (Q3W) and every two weeks (Q2W) dosing schedules.
- Multiple ongoing and durable RECIST responses observed in patients with FAPhigh and doxorubicin-sensitive diseases.
- AVA6000 results in significant changes in the pharmacokinetics of released doxorubicin in plasma and tumor versus conventional doxorubicin.
- Eight patients with FAPhigh cancers remain on study, showing promising partial and minor responses.
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