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- Ibrance (palbociclib) / Pfizer
Effect of timing of recurrence on outcomes in patients with metastatic breast cancer treated with CDK4/6 inhibitors. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6226;
In this retrospective study of ER+ HER2- MBC patients treated with 1st line CDKi + ET, timing of MBC recurrence was not associated with PFS differences after adjusting for other variables. However, patients with MBC recurring 10 years of PBC.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis
Real-world experience with CDK4/6 inhibitors in the first-line palliative setting for HR+/HER2- advanced breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6214;
Our real-world analysis suggests a non-significant trend towards improved PFS and OS for ribociclib over palbociclib when used with AIs for treating HR+/HER2- advanced breast cancer, potentially influenced by the younger age of patients on ribociclib. Further research with larger cohorts and extended follow-up is warranted to substantiate these observations.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Toxicity differences in CDK 4/6 inhibitors seen in Asian and Pacific Islanders. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6195;
The Hawaii analysis that was primarily comprised of Asians and Pacific Islanders revealed an increased incidence of toxicities, despite starting at lower doses rates for all CDK 4/6 inhibitors. This data analysis begins to highlight the importance of representative populations in clinical trials for the most effective and safest care of diverse populations.
- Ibrance (palbociclib) / Pfizer
Real-world treatment patterns and clinical outcomes among patients with HR+/HER2- advanced/metastatic breast cancer receiving palbociclib in Brazil: IRIS study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6170;
1%) were treated with palbociclib + fulvestrant, while 67 (55. Results from this initial real-world assessment of clinical outcomes in Brazil suggest that Palbociclib combinations exhibit favorable effectiveness in treating HR+/HER2- aBC/mBC disease, as measured by PFS and OS rates.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Overall survival analysis of first line CDK4/6 inhibitors in a large real-world cohort of patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6165;
In this analysis, type of CDK4/6i did not have a significant impact on OS, although pts treated with abemaciclib and ribociclib were underrepresented in the cohort due to the earlier and prevalent use of palbociclib as the first-in-class FDA-approved CDK4/6i. These data are reassuring about the use of palbociclib suggesting that a switch of CKD4/6i is not needed in pts with ongoing treatment and demonstrated benefit.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
(CDK) 4/6 inhibitors: An effective treatment for homologous recombination deficient (HRD) luminal breast cancers (BC)? () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6155;
Future exploration in larger samples of patients who have had biomarker testing is ongoing. Patients with Pik3CA mt treated with CDK4/6i presented worse clinical outcomes.
- Prolia (denosumab) / Amgen
Real-world data of efficacy and safety of denosumab on patients with breast cancer with bone metastasis: Results from Chinese clinical experience. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6132;
Denosumab was found to be effective and safe for breast cancer patients with BM in this large retrospective study. Early initiation and longer duration of denosumab treatment may generate better clinical outcomes for bone lesions by MDA criteria.
- Piqray (alpelisib) / Novartis
Results of a retrospective study on the efficacy and safety of alpelisib in patients with HR+/HER2- metastatic breast cancer in real-world clinical practice. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6130;
Early initiation and longer duration of denosumab treatment may generate better clinical outcomes for bone lesions by MDA criteria. 1%)
- AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma
Efficacy and safety of dalpiciclib, fulvestrant, and pyrotinib in HR+ HER2-low advanced breast cancer following cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors and aromatase inhibitors (AIs): A Bayesian optimal phase II trial. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6124;
P2
Based on these findings, the study will continue to enroll up to 30 participants. Clinical trial information: NCT05806671.
- Ibrance (palbociclib) / Pfizer, Herceptin (trastuzumab) / Roche, Kisqali (ribociclib) / Novartis
Real world experience with cyclin dependent kinase inhibitors in metastatic breast cancer from India. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6122;
The present study shows the real world experience with the effectiveness and tolerability of CDK inhibitors in metastatic breast cancer in India. However, large scale multi-centric studies are required to evaluate the pan India experience with these inhibitors.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Real-world comparison of the efficacy of three CDK4/6 inhibitors (CDK4/6i) in the first-line treatment of endocrine-sensitive advanced breast cancer (aBC): Single institution experience. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6111;
The PFS and OS results for palbociclib and ribociclib in this retrospective real-world study correlate with results from randomized clinical trials, confirming some inferiority of palbociclib compared to ribociclib in the context of OS. Due to the later availability of the drug, larger sample size and longer follow-up will be needed to make definitive conclusions on the efficacy of abemaciclib.
- paclitaxel / Generic mfg., doxorubicin hydrochloride / Generic mfg., gemcitabine / Generic mfg.
Gemcitabine/paclitaxel/adriamycin (GTA) as a nephron-sparing regimen in urothelial carcinoma: The MD Anderson Cancer Center (MDACC) experience. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6020;
The facilitation of cisplatin-based regimens after GTA in a subset of pts might be explained by restoring patency in partially obstructed collecting systems. This 'GTA bridging' strategy may be beneficial for pts for whom nephrostomy or ureteral stenting proves impractical or insufficient to address renal insufficiency.
- Stivarga (regorafenib) / Bayer
Single-center retrospective analysis of second-line treatment with regorafenib in patients with advanced colorectal cancer among the COVID-19 pandemic. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5805;
PFS tended to be prolonged with regorafenib plus capecitabine or immunotherapy in 12 subjects versus regorafenib alone in 19 subjects (8 months vs. 4 months, P = 0. Regorafenib alone or combined with chemotherapy/immunotherapy is safe and feasible in the second-line treatment for advanced colorectal cancer, and therefore further prospective studies can be conducted to explore combination therapies.
- Vectibix (panitumumab) / Amgen
Dermatology-related quality of life outcomes in patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) treated with fluorouracil and folinic acid with or without panitumumab (Pmab) maintenance after FOLFOX + Pmab induction: A prespecified secondary analysis of the phase 2 randomized PanaMa (AIO KRK 0212) trial. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5789;
P2
These results suggest that patient reported outcomes by FACT-EGFRI, DLQI, and Skindex-16 reflect toxicity as recorded by classic toxicity scores which are not covered by global HRQOL assessment. These data, together with HRQOL may support clinical decision-making of maintenance therapy.
- Stivarga (regorafenib) / Bayer
Regorafenib Plus for third-line treatment in metastatic colorectal cancer: A real-world study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5784;
Particularly when tumor stabilization is evident during monotherapy, the introduction of Rego Plus can offer a comparable or even longer PFS benefit, nearly doubling the PFS. Despite an elevated rate of AEs, the severity of these events did not increase, suggesting good tolerability.
- Lonsurf (trifluridine/tipiracil) / Otsuka, Stivarga (regorafenib) / Bayer
Survival benefit with regorafenib and/or trifluridine/tipiracil sequencing to rechallenge with anti-EGFR-based third-line regimens in metastatic colorectal cancer: A multicenter retrospective real-world subgroups comparison. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5779;
With the limit of the sample size, our retrospective subgroup analysis failed to validate the promising beneficial effects of anti-EGFR rechallenge prior to R and/or T treatment. A statistically significant longer PFS was only observed in patients with refractory metastatic colorectal cancer receiving T/R sequence without prior cetuxumab- or panitumumab-based regimens.
- Lonsurf (trifluridine/tipiracil) / Otsuka, Vectibix (panitumumab) / Amgen
Phase IB/II first line panitumumab, irinotecan, trifluridine/tipiracil in RAS wild-type patients with metastatic colorectal cancer: PIT study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5774;
Toxicity was manageable however significant grade 3 diarrhoea and rash was seen. There was one toxic death contributed to therapy.
- Stivarga (regorafenib) / Bayer
FOLFOX-based hepatic arterial infusion chemotherapy combined with regorafenib for unresectable colorectal liver metastases. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5764;
The mFOLFOX6 regimen was employed for HAIC, comprising oxaliplatin (85 mg/m2 for 2 h on day 1), calcium folinate (200 mg/m2 for 2 h on day 1), and 5-fluorouracil (5-Fu) administered as a bolus of 400 mg/m2 on day 1, followed by 2400 mg/m2 over 46 h. Regorafenib was administered orally at a dose of 160 mg (four 40 mg tablets) once daily for the first 21 days of each 28-day cycle, with HAIC performed during the 7 days of discontinuation. The combination of regorafenib with FOLFOX-HAIC exhibits substantial promise in managing unresectable CRLM, providing meaningful effectiveness without exacerbating toxicity.
- Predictors of receiving targeted treatment among eligible patients with metastatic colorectal cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5737;
Our findings highlight the significance of genetic counseling in facilitating access to targeted therapies, and the stark gap in uptake among minority patients. These results can inform strategies to increase access to these treatments.
- Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
Chemotherapy plus EGFR antibody as conversion treatment in RAS wild type, right-sided metastatic colon cancer: A systematic review and meta-analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5713;
We performed a systematic search of PubMed/MEDLINE and EMBASE for randomized trials reporting the overall response rate (ORR) and resection rate following chemotherapy (CT) plus anti-EGFR agents (cetuximab or panitumumab) for right-sided mCRC...Subgroup analysis of RAS/BRAF WT patients with right-sided tumors from the PARADIGM and PEAK trials showed no difference in progression-free survival (PFS) between the CT plus anti-EGFR or bevacizumab groups (11... The data indicate that augmenting chemotherapy with anti-EGFR could be a viable conversion therapy for patients with RAS/BRAF WT right-sided mCRC, underscoring its potential utility in this subset of patients.
- Stivarga (regorafenib) / Bayer
Efficacy and safety of regorafenib and/or immune checkpoint inhibitors as a second-line therapy for advanced hepatocellular carcinoma: A real-world study from a single center. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5474;
Regorafenib plus ICIs therapy is an effective promising regimen regardless of first-line treatments in advanced HCC. Combined with local treatment only showed a trend of PFS, further prospective research is needed.
- Tevimbra (tislelizumab-jsgr) / BeiGene, Lenvima (lenvatinib) / Eisai, Merck (MSD)
A real-world experience of hepatic arterial infusion chemotherapy combined with tislelizumab and lenvatinib for unresectable hepatocellular carcinoma with type IV portal vein tumor thrombus. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5468;
Pts received HAIC of modified FOLFOX (oxaliplatin, 85 mg/m2; leucovorin, 400 mg/m2; 5-fluorouracil bolus, 400 mg/m2 on day 1; 5-fluorouracil infusion, 2400 mg/m2 for 46 h), lenvatinib (8 or 12 mg once daily for body weight, 60 or ?60 kg), and tislelizumab (200 mg q3w)...4%), HAIC+Tisle+Regorafenib (5... The combination of HAIC with tislelizumab and lenvatinib represents a promising efficacy and manageable safety for uHCC pts with Vp4, which supplements the trial data for Vp4-HCC with real world outcomes.
- Avastin (bevacizumab) / Roche, Stivarga (regorafenib) / Bayer, Tecentriq (atezolizumab) / Roche
Efficacy and safety of regorafenib combined with PD-1 inhibitors in patients with advanced hepatocellular beyond atezolizumab plus bevacizumab: A retrospective analysis of real-world evidence. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5379;
The combination of HAIC with tislelizumab and lenvatinib represents a promising efficacy and manageable safety for uHCC pts with Vp4, which supplements the trial data for Vp4-HCC with real world outcomes. Though application of regorafenib combined with PD-1 inhibitors progressing after atezolizumab plus bevacizumab present safe and effective in our cohort, these data need to be confirmed in prospective comparative studies.
- Stivarga (regorafenib) / Bayer
Efficacy and safety of TACE combined with ablation and regorafenib for unresectable hepatocellular carcinoma: A real-world study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5371;
Though application of regorafenib combined with PD-1 inhibitors progressing after atezolizumab plus bevacizumab present safe and effective in our cohort, these data need to be confirmed in prospective comparative studies. TACE combined with ablation and regorafenib is an effective, safe, and promising second-line treatment option for patients with unresectable HCC after progression from first-line therapy.
- Opdivo (nivolumab) / BMS, foslinanib immediate release (CVM-1118) / TaiRx
CVM-1118: A potent oral anti-vasculogenic mimicry (VM) agent in combination with nivolumab in patients with unresectable advanced hepatocellular carcinoma (HCC) () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5337;
P2
These data support further development of the combination of CVM-1118 and nivolumab in pts with unresectable advanced HCC. Clinical trial information: NCT05257590.
- Stivarga (regorafenib) / Bayer
A multi-center retrospective study on the efficacy and safety of regorafenib plus immune checkpoint inhibitors with or without TACE as a second-line treatment for advanced hepatocellular carcinoma. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5299;
Clinical trial information: NCT05257590. Regorafenib plus ICIs with TACE showed a promising efficacy with favorable safety in HCC patients with PD-1 inhibitor resistance, especially in the standard second line patients.
- Stivarga (regorafenib) / Bayer
Efficacy and safety of regorafenib plus ICIs as second-line treatment in advanced HCC post-frontline treatment failure: A real-world study from a single center. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5294;
8% of patients, sorafenib plus ICIs in three patients, apatinib plus ICIs, donafenib plus ICIs, and bevacizumab plus ICIs each in one patient... Regorafenib with ICIs is a promising and tolerable second-line treatment for advanced HCC after initial therapy failure.
- Tevimbra (tislelizumab-jsgr) / BeiGene, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Second-line systematic strategy options for the progression of lenvatinib plus tislelizumab treating unresectable hepatocellular carcinoma: A retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5269;
If the PFS of LEN+TIS was shorter than 8 months, Lenvatinib should be changed to Regorafenib, Tislelizumab could be not changed. And if the PFS of LEN+TIS was longer than 8 months, Lenvatinib and Tislelizumab should be changed at the same time, which seemed to achieve better results.
- Prevalence of adverse events following bispecific antibody therapy in non-Hodgkin lymphoma: A meta-analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5035;
The rates of high grade CRS and ICANS are low. The heterogeneity of the findings could be attributed by an underreporting of TRAE and small sample sizes from various studies.
- Neupogen (filgrastim) / Kyowa Kirin, Amgen
Relapse Hodgkin lymphoma autologous stem cell transplant long term follow up. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4999;
The preparative regimen was carmustine, etoposide, and melphalam (CEM, 1992-2005) and BCNU, etoposide, cytarabine and melphalan (BEAM, 2006 to present)...All patients underwent mobilized peripheral blood stem collections with high dose filgrastim, and starting in 2008 were mobilized with both filgrastim and plexiform... Patients with relapsed HL can achieve long term curative outcomes when treated with ABMT with most frequent long term complication being cardiomyopathy.
- Remicade (infliximab) / J&J, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
Immunosuppressant drug-associated skin cancer: A real-world pharmacovigilance database analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4963;
While methotrexate use is known to possess an increased risk, it had the lowest odds of skin cancer compared to other drugs in the study. Prospective studies are needed to understand the true incidence of skin cancer associated with the use of immunosuppressant drugs.
- Stivarga (regorafenib) / Bayer
Optimizing patient (pt) care through pt-focused resources to prevent and manage hand-foot skin reaction (HFSR). () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4837;
Furthermore, it demonstrates how MI can bridge the gap between pt insights and clinical knowledge by addressing their needs and providing practical and trustworthy tools. Not only does this initiative enhance pt understanding but also empowers pts to take a more active role in their treatment and fosters shared-decision making.
- Nplate (romiplostim) / Amgen, Kyowa Kirin
Romiplostim for chemotherapy induced thrombocytopenia in solid tumors: A meta-analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4787;
It also shows that a majority of the patients were able to resume their full dose chemotherapy when maintained on romiplostim. The incidence rate of thromboembolic events with romiplostim believed to be consistent with what expected of this population with majority having advanced/high-risk malignancies.
- bemarituzumab (AMG 552) / Amgen
SCR-A002, a novel FGFR2b-targeting antibody-drug-conjugate for solid tumors. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4747;
The incidence rate of thromboembolic events with romiplostim believed to be consistent with what expected of this population with majority having advanced/high-risk malignancies. SCR-A002 showed potent anti-tumor efficacy in preclinical data, which suggest that SCR-A002 is expected to provide a new treatment option as single agent or combo with SoC for patients with FGFR2b-overexpressing solid tumor.
- Krazati (adagrasib) / BMS, Lumakras (sotorasib) / Amgen
Characterization of BTX-10908, a first-in-class, orally bioavailable SOS1 bifunctional degrader for the treatment of KRAS- and RTK-driven cancers. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4717;
SCR-A002 showed potent anti-tumor efficacy in preclinical data, which suggest that SCR-A002 is expected to provide a new treatment option as single agent or combo with SoC for patients with FGFR2b-overexpressing solid tumor. Our developmental candidate, BTX-10908, displayed robust in vitro and in vivo activity supporting its further development for monotherapy and combination therapies of KRAS and RTK-driven cancers.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Evaluation of cyclin-dependent kinase 4/6 inhibitor-induced serum creatinine elevations in patients with hormone receptor positive breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4626;
Pseudo-sCr elevation appears to be a class effect of CDK4/6i, with similar rates of sCr elevation observed across the three CDK4/6i currently FDA approved. Further analyses evaluating differences by age, race, and stage are ongoing.
- Adherence for members taking oral oncolytic agents undergoing dose modification strategies. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4622;
Dose modification was associated with significant decreases in adherence to oral oncolytic medications. Interventions designed to minimize dose modifications or to provide additional member support during a dose modification may optimize oral oncolytic adherence.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
Adherence and persistence of encorafenib in combination with cetuximab among patients with BRAF metastatic CRC in the United States (US) based on two claims databases. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4596;
This up-to-date study provides current real-world evidence on the use of enco + EGFR in mCRC BRAF-m patients in the US. The results show high levels of adherence to the treatment, suggesting high tolerability to encorafenib, and persistence consistent with clinical trial evidence.
- Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon, Kanjinti (trastuzumab-anns) / Amgen, Daiichi Sankyo, AbbVie, Herceptin (trastuzumab) / Roche
Trastuzumab biosimilars interchangeability: Preliminary real-world data in neoadjuvant breast cancer setting. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4543;
Brazilian Ministry of Health, as the only provider, has a policy based on lowest cost for trastuzumab compound, causing constant changes along pts treatments. Furthermore, it is expected that Brazil has the potential to evaluate the IC in thousands of pts prospectively next years.
- Kymriah (tisagenlecleucel-T) / Novartis
Evolution of tisagenlecleucel use for the treatment of pediatric and young adult relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL): Center for International Blood & Marrow Transplant Research (CIBMTR) registry results. (S504) - Apr 24, 2024 - Abstract #ASCO2024ASCO_4040;
Pediatric and young adult pts with r/r B-ALL are receiving tisagenlecleucel earlier in the course of their disease treatment, reducing the use of HSCT for r/r disease, and prolonging RFS. As both real-world and clinical trial data supporting the curative potential of tisagenlecleucel grow, the use of HSCT in pts with remission after CAR-T should be carefully evaluated.
- Keytruda (pembrolizumab) / Merck (MSD), Stivarga (regorafenib) / Bayer
International, open-label phase 2 study of regorafenib plus pembrolizumab in patients with advanced hepatocellular carcinoma (HCC) previously treated with immune checkpoint inhibitors (ICI). (Hall D1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3963;
P2
Regorafenib plus pembrolizumab had modest activity in second line after first-line ICI regimens. The safety profile of the combination was consistent with those of either drug.
- Keytruda (pembrolizumab) / Merck (MSD), Stivarga (regorafenib) / Bayer
REPLACE: A phase III, randomized, open-label trial to evaluate the safety and efficacy of regorafenib and pembrolizumab versus locoregional therapy (LRT) with transarterial chemoembolization (TACE) or transarterial radioembolization (TARE), for the first-line treatment of intermediate-stage hepatocellular carcinoma (HCC) with beyond up-to-7 criteria. (Hall A; Poster Bd #: 170a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3929;
P3
The estimated enrollment is 496 patients from approximately 14 countries. Recruitment started in October 2023 and is currently ongoing.
- Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD), Tecentriq (atezolizumab) / Roche
Atezolizumab + bevacizumab versus lenvatinib as first-line systemic therapy for treatment of hepatocellular carcinoma in a real-world population: Outcomes from the HCC CHORD database. (Hall A; Poster Bd #: 91) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3842;
This study provided real-world efficacy outcomes for AB directly compared to LEN in the first-line treatment of HCC in a Western country. AB was correlated with superior OS compared to LEN, but PFS and RR appear to be similar.
- Stivarga (regorafenib) / Bayer
Phase II randomized study of maintenance therapy with regorafenib (REGO) versus placebo after first-line platinum and fluoropyrimidines-based chemotherapy in HER2 negative locally advanced/metastatic gastric (GC) or gastroesophageal junction (GEJ) cancer: Results of a-MANTRA study (GOIRC-05-2016). (Hall A; Poster Bd #: 36) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3789;
P2
No significant safety concerns were raised. New study designs following the REGO with ICIs are currently underway.
- Opdivo (nivolumab) / BMS, Stivarga (regorafenib) / Bayer
First-line regorafenib with nivolumab and FOLFOX or CapeOX in patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: A single-arm, phase Ib/II trial (REGONIVOCTx, EPOC2104). (Hall A; Poster Bd #: 32) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3785;
P1/2
The results of biomarker analysis will be presented. A randomized, phase III trial is planned.
- Stivarga (regorafenib) / Bayer
Phase II trial of regorafenib in metastatic medullary thyroid carcinoma (MTC) and radioactive iodine refractory differentiated thyroid carcinoma (RAIR DTC). (Hall A; Poster Bd #: 425) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3559;
P2
Regorafenib clinical trial did not reach its primary endpoints in MTC and DTC. Analyses are planned to investigate impact of prior VEGFR inhibitor exposure, biomarkers and resistance mechanisms.
- Imdelltra (tarlatamab-dlle) / Amgen
DeLLphi-301: Tarlatamab phase 2 trial in small cell lung cancer (SCLC) (S406) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3262;
P2
Analyses are planned to investigate impact of prior VEGFR inhibitor exposure, biomarkers and resistance mechanisms. Tarlatamab showed promising efficacy and a favorable benefit-risk profile in patients with previously treated SCLC and stable brain metastases.
- N2M2/NOA-20: Phase I/IIa umbrella trial of molecularly matched targeted therapies plus radiotherapy in patients with newly diagnosed glioblastoma without MGMT promoter hypermethylation. (S100bc) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3218;
P1/2
N 2 M 2 allows for elaborate molecular testing being integrated into the treatment decision and efficient determination of treatment activity for patients with newly diagnosed glioblastoma. There is clinical activity of temsirolimus in patients with tumors harboring an activated mTOR pathway although this is not positively prognostic without mTOR inhibition; there is no clinical activity for asunercept and atezolizumab in not molecularly selected patients and also palbociclib in molecularly selected patients.
- onCARlytics (CF33-CD19) / Imugene, VAXinia (CF33-hNIS) / Imugene, Blincyto (blinatumomab) / Astellas, Amgen
Combination therapy with the oncolytic virus CF33-CD19 and blinatumomab for the treatment of advanced solid tumors. (Hall A; Poster Bd #: 157a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3086;
P1
doi: 10.1126/scitranslmed.aaz1863. PMID: 32878978.
- CT-0525 / CARISMA Therap, CT-0508 / CARISMA Therap
A phase 1, first-in-human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2-overexpressing solid tumors. (Hall A; Poster Bd #: 154b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3081;
P1
Primary endpoints include assessment of safety and tolerability, as well as manufacture feasibility. Correlative assessments include pre- and post-treatment biopsies and blood samples for safety, immunogenicity, pharmacokinetics, tumor trafficking, TME modulation, epitope spreading, and other translational biomarkers.