Imfinzi plus chemotherapy approved in the US for mismatch repair deficient advanced or recurrent endometrial cancer
- AstraZeneca’s Imfinzi (durvalumab) combined with carboplatin and paclitaxel, followed by Imfinzi monotherapy, has been approved by the FDA for treating adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
- The approval is based on the DUO-E Phase III trial, which showed a 58% reduction in the risk of disease progression or death in patients with dMMR endometrial cancer compared to chemotherapy alone.
- Endometrial cancer is the fourth most common cancer in women in the US, with over 66,000 diagnoses and nearly 12,000 deaths in 2022.
- The safety profile of the Imfinzi and chemotherapy regimen was generally manageable and consistent with prior clinical trials.
- Regulatory applications for Imfinzi and the combination of Imfinzi and Lynparza are under review in the EU, Japan, and several other countries based on the DUO-E results.
- The DUO-E trial continues to assess overall survival (OS) as a key secondary endpoint for both treatment arms.
Read more
Calquence plus chemoimmunotherapy reduces risk of disease progression in mantle cell lymphoma
- ECHO Phase III trial shows Calquence (acalabrutinib) plus bendamustine and rituximab significantly improves progression-free survival (PFS) in untreated mantle cell lymphoma (MCL).
- Calquence combination reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy (HR 0.73; p=0.016).
- Median PFS was 66.4 months for the Calquence combination versus 49.6 months for standard chemoimmunotherapy.
- A favorable trend in overall survival (OS) was observed, though data were not mature at the time of analysis (HR 0.86; p=0.2743).
- Pre-specified analysis censoring COVID-19 deaths showed further improved PFS, with a 36% reduction in risk (HR 0.64; p=0.0017).
- The trial will continue to assess OS as a key secondary endpoint.
Read more
Roche’s Phase III STARGLO study demonstrates Columvi significantly extends survival in people with relapsed or refractory diffuse large B-cell lymphoma
- The Phase III STARGLO study met its primary endpoint of overall survival with a 41% reduction in the risk of death for patients treated with Columvi plus chemotherapy.
- Columvi combination showed a median overall survival of 25.5 months compared to 12.9 months for the control group.
- Key secondary endpoints, including progression-free survival, also showed significant improvement with a 63% reduction in risk of disease worsening or death.
- Adverse events were higher with the Columvi combination, with cytokine release syndrome being the most common, primarily occurring in Cycle 1.
- Results will be submitted to global health authorities, including the FDA and EMA, for potential regulatory approvals.
- Columvi is also being investigated in other aggressive lymphomas and has received Breakthrough Therapy Designation by the FDA for relapsed or refractory mantle cell lymphoma.
Read more
Genentech’s phase III STARGLO study demonstrates Columvi significantly extends survival in people with relapsed or refractory diffuse large B-cell lymphoma
- Genentech announced positive results from its Phase III STARGLO study of Columvi (glofitamab-gxbm) in combination with GemOx versus R-GemOx for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
- The study met its primary endpoint, showing a 41% reduction in the risk of death with Columvi plus GemOx compared to R-GemOx.
- Median overall survival (OS) was not reached with Columvi, while it was nine months for R-GemOx.
- Key secondary endpoints were also met, with a 63% reduction in the risk of disease worsening or death (progression-free survival, PFS).
- Adverse events were higher with the Columvi combination, with cytokine release syndrome being the most common but generally low grade.
- Results will be submitted to global health authorities, including the FDA and EMA, for potential full approvals.
Read more
FDA approves Blincyto in CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase
- The FDA has approved Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase.
- This approval is based on the Phase 3 E1910 clinical trial, which showed that Blincyto added to multiphase consolidation chemotherapy reduced the risk of death by 58% and demonstrated superior overall survival compared to chemotherapy alone.
- The 3-year overall survival (OS) rate was 84.8% in the Blincyto plus chemotherapy arm versus 69% in the chemotherapy arm, with a hazard ratio for OS of 0.42.
- The 5-year OS rate was 82.4% in the Blincyto plus chemotherapy arm compared to 62.5% in the chemotherapy arm, with a median follow-up of 4.5 years.
- Blincyto is the first and only bispecific T-cell engager (BiTE) therapy approved for consolidation treatment regardless of measurable residual disease (MRD) status.
- The E1910 study was sponsored by ECOG-ACRIN Cancer Research Group with public funding from the National Cancer Institute (NCI), and Amgen provided Blincyto and support through an NCI Cooperative Research and Development Agreement.
Read more
LIXTE Biotechnology Holdings announces collaboration on a new colon cancer clinical trial
- LIXTE Biotechnology Holdings collaborates with Roche and the Netherlands Cancer Institute (NKI) on a new clinical trial.
- The trial will test LIXTE’s lead compound, LB-100, in combination with Roche's atezolizumab (Tecentriq) for MSI Low metastatic colon cancer.
- LB-100 aims to increase the immune system's recognition of colon cancer cells.
- Approximately 85% of colon cancers are MSI Low and unresponsive to current immunotherapies.
- The trial is listed as NCT06012734 at clinicaltrials.gov.
- Recent pre-clinical data suggests LB-100 can turn immunologically 'cold' tumors 'hot,' potentially enhancing immunotherapy response.
Read more
Talvey (talquetamab) demonstrated highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma
- 24-month overall survival rate of 67% achieved with talquetamab 0.8mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study.
- Patients treated with talquetamab maintained high overall response rates and durable responses, irrespective of prior T-cell redirection therapy.
- In the Q2W cohort, a median duration of response (DOR) of 17.5 months was observed, with median DOR not reached in patients with complete response or better.
- Talquetamab showed strong efficacy in patients with prior T-cell redirection therapy exposure, with 55.1% achieving very good partial response or better.
- Infection rates remained lower than in studies of BCMA-targeted bispecific antibodies, with no increase in grade 3/4 infections observed.
- MonumenTAL-2 study supports continued durable responses at one year with the investigational combination of talquetamab and pomalidomide.
Read more
Phase 2 findings show Wugen’s investigational allogeneic CAR-T, WU-CART-007, was highly effective and surpassed standard of care in treating hard-to-treat T-ALL/LBL
- WU-CART-007 demonstrated a clinically manageable safety profile and anti-leukemic activity in patients with relapsed/refractory (R/R) T-ALL/LBL.
- The study showed a composite complete remission rate (CRc) of 73% and an overall response rate of 91%.
- Median duration of response (mDOR) was 6.2 months, with 46% of patients remaining in continuous remission at 4.3 to 8.6 months.
- Pharmacokinetic analysis revealed rapid expansion and persistence of the allogeneic cell therapy, with no anti-drug antibodies detected.
- Wugen plans to initiate a follow-up study in Q4 2024, focusing on pediatric and minimal residual disease (MRD) patients.
- WU-CART-007 has received multiple designations from the FDA and PRIME designation in the EU for the treatment of R/R T-ALL and T-LBL.
Read more
Nurix Therapeutics presents positive results from ongoing clinical trial of NX-5948 in patients with relapsed refractory chronic lymphocytic leukemia (CLL) at the European Hematology Association Congress (EHA2024)
- Objective response rate of 69.2% observed in heavily pretreated CLL patients, including those with BTK inhibitor resistance mutations.
- Clinical responses in CLL patients were rapid and deepened with longer treatment duration.
- Nurix plans to advance NX-5948 into pivotal trials in 2025.
- Safety findings showed NX-5948 was well tolerated across all doses, with common adverse events including purpura/contusion, thrombocytopenia, and neutropenia.
- Responses were observed across all patient populations regardless of prior treatment, baseline mutations, or CNS involvement.
- Next steps include expanding the Phase 1b trial across a range of CLL subpopulations to prepare for pivotal, registration-directed clinical evaluation in 2025.
Read more
Zymeworks announces FDA clearance of investigational new drug application for ZW171
- Zymeworks Inc. received FDA clearance for the investigational new drug (IND) application for ZW171.
- ZW171 is a novel 2+1 T-cell targeting bispecific antibody for mesothelin (MSLN)-expressing cancers.
- The antibody aims to enhance tumor selectivity and improve safety, addressing limitations of current bispecific T-cell engagers.
- ZW171 targets cancers such as ovarian cancer, non-small cell lung cancer, and mesothelioma.
- Clinical development of ZW171 is expected to begin in 2024, with regulatory applications in other non-US jurisdictions planned for the second half of 2024.
- ZW171 is designed to improve tolerability and anti-tumor activity by selectively binding to tumors and sparing normal tissues.
Read more
