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- Imlygic (talimogene laherparepvec) / Amgen
Phase I trial of talimogene laherparepvec for the treatment of peritoneal surface malignancies (TEMPO). (Hall A; Poster Bd #: 147) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3068;
P1
TEMPO successfully identified 4x10 8 pfu as the RP2D for TVEC. Notably, the RMST increased with increasing doses of TL.
- Imlygic (talimogene laherparepvec) / Amgen
SH2B3 mutation as a potential resistance mechanism to oncolytic virus therapy. (Hall A; Poster Bd #: 57) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2981;
This is the first study to report a possible genetic driver for OV resistance. We introduced using CRISPR-HDR P521L SH2B3 in MCC cell lines to investigate its impact on LNK expression and its role as a mechanism of OV treatment resistance, with results to be presented.
- Prolia (denosumab) / Amgen
Incidence of osteonecrosis of the jaw (ONJ) in the randomized non-inferiority phase III trial SAKK 96/12 REDUSE comparing denosumab (DN) administered every 4 weeks (q4w) versus every 12 weeks (q12w). (Hall A; Poster Bd #: 196) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2817;
P3
Administration of DN q12w reduces the risk of ONJ and/or tooth infections substantially. The numerical difference of events to the standard arm as well as the time to first ONJ and/or tooth infection is clinically relevant with a risk reduction by 33%.
- Vectibix (panitumumab) / Amgen, Lumakras (sotorasib) / Amgen
Overall survival (OS) of phase 3 CodeBreaK 300 study of sotorasib plus panitumumab (soto+pani) versus investigator's choice of therapy for KRAS G12C-mutated metastatic colorectal cancer (mCRC). (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2724;
P3
While CodeBreaK 300 was not powered to detect a statistically significant difference in OS, the study showed a trend toward improved OS for patients randomized to soto960+pani. Together with PFS and response rates, these results support the use of soto960+pani as a potential SOC for pts with chemorefractory KRAS G12C-mutated mCRC.
- etrumadenant (AB928) / Arcus Biosci, Gilead
ARC-9: A randomized study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC). (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2721;
P1/2
Further investigation of this promising regimen is warranted given the clinically meaningful PFS and OS improvement. Table
- Avastin (bevacizumab) / Roche, Vectibix (panitumumab) / Amgen
Acquired gene alteration patterns and post-progression survival: PARADIGM study analysis. (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2720;
P, P3
Distinctive patterns of acquired gene alterations were observed in PAN- and BEV-treated pts with PD. Co-occurrence of gene alterations, particularly in the RTK/RAS pathway, was more prevalent with PAN than BEV.
- Vectibix (panitumumab) / Amgen
FU/FA maintenance therapy with or without panitumumab (pmab) in RAS wild-type metastatic colorectal cancer (mCRC) (PanaMa, AIO KRK 0212): Updated efficacy analyses. (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2719;
P2
PFS remained improved by the addition of pmab to FU/FA maintenance therapy, while OS was not significantly longer. Re-induction of pmab+mFOLFOX6 did not provide benefit following pmab maintenance regarding PFS.
- Stivarga (regorafenib) / Bayer
REPROGRAM-02: A phase II-III study evaluating an induction treatment with regorafenib and metronomic chemotherapy before the second line chemotherapy in metastatic colorectal cancer. (Hall A; Poster Bd #: 297b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2702;
P2, P2/3
Patients with mCRC in progression after a 1 st of chemotherapy, receive either (i) regorafenib (REDOS schedule: 80 mg for week 1, 120 mg for week 2 and 160 mg for week 3 of the first cycle) in combination with CT (capecitabine 625mg/m 2 twice daily and cyclophosphamide 50 mg daily) and low-dose aspirin (75 mg once daily) during 8 weeks as an induction therapy before chemotherapy initiation in the second-line, or (ii) the second line standard chemotherapy (FOLFOX or FOLFIRI with anti-VEGF until progression or unacceptable toxicity)...Assuming a significance level of 5% and a power of 80%, a sample size of 93 patients is needed for the phase II and 446 patients for the phase III. The enrollment is ongoing, 13 patients have already been recruited.
- Epidaza (chidamide) / Chipscreen, Hansizhuang (serplulimab) / Fosun Pharma
Efficacy and safety of chidamide in combination with serplulimab and standard third-line treatments in advanced colorectal cancer: A single arm, exploratory phase 2 trial. (Hall A; Poster Bd #: 296b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2701;
The enrollment is ongoing, 13 patients have already been recruited. The key inclusion criteria are: pathologically confirmed colorectal malignancy; age ?18 years, regardless of gender; estimated survival ?3 months; ECOG score 0-1; at least one measurable lesion according to iRECIST criteria; requiring third-line or beyond treatment and no prior treatment with PD1 monoclonal antibody, regorafenib/fruquintinib or TAS-102
- Stivarga (regorafenib) / Bayer, Tecentriq (atezolizumab) / Roche, zanzalintinib (XL092) / Exelixis
STELLAR-303: A randomized phase 3 study of zanzalintinib (XL092) plus atezolizumab versus regorafenib in previously treated metastatic colorectal cancer. (Hall A; Poster Bd #: 295a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2698;
P3
Safety will also be assessed. STELLAR-303 enrollment is ongoing in the US, Europe, and Asia-Pacific region.
- fadraciclib (CYC065) / Cyclacel
Efficacy of fadraciclib (CYC065), a novel dual CDK2/9 inhibitor, on patient-derived models of colorectal cancer. (Hall A; Poster Bd #: 259) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2664;
CDK2/9 inhibition impacts multiple critical pathways involved in transcription, mitosis and apoptosis. Further studies will be needed to reveal molecular biomarkers of sensitivity and resistance to this novel agent.
- Fruzaqla (fruquintinib) / Takeda
Efficacy and safety of fruquintinib in patients with metastatic colorectal cancer according to prior treatment sequence in the refractory setting: Results from FRESCO and FRESCO-2. (Hall A; Poster Bd #: 242) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2648;
P3
Improvement with F was similar for OS and PFS despite the number and sequence of prior regimens. F provides a new tx option for pts with previously treated mCRC regardless of prior TAS or rego exposure.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
Early [ 18 F]FDG PET/CT response evaluation after a single dose of anti-EGFR therapy as a predictive biomarker for treatment benefit in patients with advanced colorectal cancer. (Hall A; Poster Bd #: 239) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2645;
P1/2
Selection of patients with left-sided RASwt/BRAFwt mCRC successfully identifies the majority (91%) of patients with clinical benefit from anti-EGFR monotherapy. For mCRC patients with inconclusive mutational screens early [ 18 F]FDG PET/CT evaluation may have clinical value to predict treatment benefit.
- 5-fluorouracil / Generic mfg.
Negative hyperselection and mechanisms of acquired resistance to first-line chemotherapy plus anti-EGFR in patients (pts) with pMMR RAS/BRAF wild-type (wt) metastatic colorectal cancer (mCRC): A translational analysis of the TRIPLETE trial. (Hall A; Poster Bd #: 235) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2641;
For mCRC patients with inconclusive mutational screens early [ 18 F]FDG PET/CT evaluation may have clinical value to predict treatment benefit. TRIPLETE is a phase III trial where 435 pts with untreated RAS/BRAF wt
- Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Stivarga (regorafenib) / Bayer
A phase II clinical evaluation of radiofrequency ablation (RFA) combined with regorafenib and toripalimab in patients with colorectal cancer with liver metastases. (Hall A; Poster Bd #: 229) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2635;
P2
The combination of RFA, regorafenib, and toripalimab has not shown encouraging efficacy in patients with CRC liver metastases. However, the observed safety profile is acceptable.
- Lonsurf (trifluridine/tipiracil) / Otsuka, T-Guard (SPV-T3a-RTA/WT1-RTA) / Xenikos, Stivarga (regorafenib) / Bayer
A randomized study evaluating tailoring of advanced/metastatic colorectal cancer (mCRC) therapy using circulating tumor DNA (ctDNA): TACT-D. (Hall A; Poster Bd #: 220) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2626;
P2
Adjusted for this prognostic impact, ?ctDNA between C1D1 and C1D15 was predictive of clinical outcomes. Efforts are needed to establish novel signatures, optimal cutoffs/intervals for assessing ctDNA response in mCRC, tailored to pts and their therapy.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
Real-world use of anti-EGFR therapy in metastatic colorectal cancer. (Hall A; Poster Bd #: 215) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2621;
Based on results from the Flatiron Health database, use of anti-EGFR therapy is enriched among patients with biomarker-based indications for treatment. Notably, anti-EGFR therapy was employed in only 56.6% of patients with RAS and RAF wildtype, left-sided mCRC, with decreased use observed from 2013 to 2023.
- Therapeutic implications of acquired high tumor mutational burden (TMB-H) after targeted therapy (TT) in metastatic colorectal cancer (mCRC). (Hall A; Poster Bd #: 205) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2611;
In this context, TMB may not be an accurate reflection of tumor immunogenicity as it does not distinguish between clonal and subclonal alterations. Our data suggest that pts w/ acquired TMB-H following TT are unlikely to benefit from ICB.
- Vectibix (panitumumab) / Amgen
Spatial patterns in the tumor immune microenvironment as prognostic and predictive biomarkers of panitumumab (Pmab), fluorouracil and folinic acid (FU/FA) or FU/FA maintenance therapy following Pmab+FOLFOX induction in RAS wildtype (wt) metastatic colorectal cancer (mCRC): PanaMa (AIO KRK0212) trial. (Hall A; Poster Bd #: 202) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2609;
Several factors of the immune microenvironment were found to be prognostic factors for PFS and OS in patients with RAS wt mCRC. Of those, CD8, CD163, LAG3, CD45, Immunoscore, and an Immunoactivation-score were identified as independent predictive markers for benefit from the addition of Pmab to FU/FA maintenance therapy, suggesting that immune activation might be a crucial component of EGFR-antibody efficacy.
- Vectibix (panitumumab) / Amgen
AGITG MONARCC: A randomized phase 2 study of panitumumab monotherapy and panitumumab (pan) plus 5 fluorouracil (FU) as first-line therapy for RAS and BRAF wild type metastatic colorectal cancer (Hall A; Poster Bd #: 198) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2605;
6-month PFS in both arms was consistent with the hypothesized rate of 73% achieved with FU/bev, whilst the rate was numerically higher for arm B. Baseline comprehensive geriatric assessments were feasible and OTU was high in both arms. Both treatment arms might be suitable first-line options in appropriately selected patients.
- Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
Consensus molecular subtypes (CMS) as prognostic and predictive biomarkers of RAS wild-type (WT) metastatic colorectal cancer (mCRC): Pooled analysis of the randomized trials FIRE-1, FIRE-3, XELAVIRI, and PanaMa. (Hall A; Poster Bd #: 192) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2599;
CMS were confirmed as prognostic biomarkers and might contain predictive information for the choice of anti-EGFR or anti-VEGF antibodies in RAS WT mCRC. Prospective validation remains mandatory.
- Vectibix (panitumumab) / Amgen
Combined amphiregulin and epiregulin expression as a prognostic and predictive biomarker of panitumumab (Pmab), fluorouracil, and folinic acid (FU/FA) or FU/FA maintenance therapy following Pmab+FOLFOX induction in RAS wildtype metastatic colorectal cancer (mCRC): PANAMA trial (AIO-KRK-0212). (Hall A; Poster Bd #: 191) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2598;
Combined AREG and EREG mRNA expression was confirmed as prognostic biomarker for mCRC patients receiving maintenance treatment. Efficacy of maintenance treatment might potentially be higher for Pmab+FUFA maintenance in mCRC with high combined AREG / EREG expression in the PanaMa trial.
- Cost-effectiveness analysis of later-line treatments for refractory metastatic colorectal cancer. (Hall A; Poster Bd #: 188) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2595;
In the base case, ReDO had a lower treatment cost than TAS-BEV and FRUQ, especially during the first month of dose optimization. TAS-BEV had the highest total cost, partly due to the cost of managing neutropenia and GCSF use.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Comparison of antitumor efficacy of first-line palbociclib, ribociclib, or abemaciclib in patients with HR+/HER2- aBC: Results of the multicenter, real-world, Italian study PALMARES-2. (Hall D1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2573;
The real-world study PALMARES-2 revealed different antitumor efficacy of individual CDK4/6i in HR+/HER2- aBC patients. Longer follow-up is required to study if Palbociclib, Ribociclib and Abemaciclib are associated with different overall survival.
- Verzenio (abemaciclib) / Eli Lilly
Innovation of the first-line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for patients with HR-positive HER2-negative advanced metastatic breast cancer (JBCRG-M08; AMBER study). (Hall A; Poster Bd #: 105a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2563;
Based on PFS data in MONARCH3 study, the threshold and expected value of the 2-year PFS rate were estimated to be 45% and 55%, respectively, and target sample size was calculated as 160 patients. Patient enrollment started in December 2022 and run through December 2024; as of December 2023, 54 patients have been enrolled.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Implementing geriatric assessment for dose optimization of CDK 4/6 inhibitors in older breast cancer patients (IMPORTANT trial): A pragmatic randomized-controlled trial. (Hall A; Poster Bd #: 104a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2561;
P3
In total, 495 patients are planned to be included to allow 346 vulnerable/frail patients to be randomized. Enrollment: The trial is open for recruitment since February 2024 with a recruitment period of 30 months.
- vepdegestrant (ARV-471) / Arvinas, Pfizer, atirmociclib (PF-07220060) / Pfizer
TACTIVE-K: Phase 1b/2 study of vepdegestrant, a proteolysis targeting chimera (PROTAC) estrogen receptor (ER) degrader, in combination with PF-07220060, a cyclin-dependent kinase (CDK)4 inhibitor, in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer. (Hall A; Poster Bd #: 103b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2560;
P1/2
Previously presented at ESMO Breast Cancer 2024, FPN: 264TiP, M Telli, et al. Reused with permission.
- giredestrant (GDC-9545) / Roche
pionERA Breast Cancer (BC): Phase III study of first-line (1L) giredestrant vs. fulvestrant, both combined with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), in patients (pts) with estrogen receptor-positive (ER+), HER2 (Hall A; Poster Bd #: 103a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2559;
P3
An interim OS analysis is planned at the time of the primary PFS analysis; an independent data monitoring committee will be in place for safety. Target enrollment: 1050 pts; recruitment ongoing.
- Fablyn (lasofoxifene) / Sermonix, Verzenio (abemaciclib) / Eli Lilly
Open-label, randomized, multicenter, phase 3, ELAINE 3 study of the efficacy and safety of lasofoxifene plus abemaciclib for treating ER+/HER2-, locally advanced or metastatic breast cancer with an ESR1 mutation. (Hall A; Poster Bd #: 101b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2556;
P3
The ELAINE 1 trial showed numerically greater progression-free survival (PFS, median ~6 vs 4 mos; P=0.138), objective response rate (ORR, 13% vs 3%; P=0.124), and clinical benefit rate (CBR, 37% vs 22%; P=0.117) with LAS monotherapy versus the ER degrader fulvestrant (fulv), with a favorable safety profile (1)...Key inclusion criteria are pre- and postmenopausal women and men aged ?18 yrs; ER+/HER2-, locally advanced and/or mBC (measurable and/or non-measurable disease); ?1 acquired ESR1 mutation; progression on an aromatase inhibitor plus palbociclib or ribociclib as their first hormonal treatment for advanced/mBC; and ?1 line of chemotherapy in the advanced/metastatic setting...Ann Oncol. 2023; 34:1131-1140.
- Ibrance (palbociclib) / Pfizer
Overall survival with palbociclib (PAL) plus an aromatase inhibitor (AI) versus AI alone in older patients (pts) with de novo, HR+/HER2? metastatic breast cancer: A SEER-Medicare analysis. (Hall A; Poster Bd #: 89) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2541;
This comparative effectiveness study showed that PAL+AI was associated with significantly prolonged OS vs AI alone in the 1L treatment of older pts with de novo HR+/HER2- mBC treated in US clinical practice using the SEER-Medicare database. Our results add to the body of evidence on the survival benefit of PAL+AI in this population.
- Orserdu (elacestrant) / Menarini
Elacestrant in various combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (adv/mBC): Preliminary data from ELEVATE, a phase 1b/2, open-label, umbrella study. (Hall A; Poster Bd #: 47) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2499;
P1/2
To address other resistance mechanisms and enable oral-oral combinations, ELEVATE (NCT05563220) is evaluating elacestrant in combination with everolimus, alpelisib, ribociclib, palbociclib, or abemaciclib. The combinations evaluated are consistent with the known safety profiles of everolimus, alpelisib, ribociclib and palbociclib with standard of care endocrine therapy, demonstrating the potential of elacestrant to be combined with targeted therapies, enabling all oral regimens.
- Ibrance (palbociclib) / Pfizer
Nationwide real-world practice pattern and clinical data of palbociclib in patients with HR(+), HER2(-) metastatic breast cancer (KCSG BR21-15). (Hall A; Poster Bd #: 46) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2498;
Palbociclib showed OS over 60 months, comparable to other pivotal clinical trials. Further follow-up analysis of PFS2 and subsequent treatment is warranted.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Real-world treatment outcomes in patients with HR+ HER2- advanced breast cancer treated with CDK4/6 inhibitors and endocrine therapy. (Hall A; Poster Bd #: 45) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2497;
We retrospectively analyzed clinical data of HR+/HER2- ABC pts administered palbociclib (PAL), ribociclib (RIB) or abemaciclib (ABM) added to either 1 st or 2 nd line ET...1254 pts (83%) received 1 st line CDK4/6i, in 841 (67%) combined with aromatase inhibitor (AI) and in 413 (33%) with fulvestrant (FUL)... Identifying predictive factors of response is essential for the rational use of CDK4/6i and ET in HR+/HER2- ABC.
- Ibrance (palbociclib) / Pfizer
Impact of prior anticancer treatments on palbociclib (PAL) clinical outcomes in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2?) advanced breast cancer (ABC) in real-world settings. (Hall A; Poster Bd #: 33) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2485;
In 1LOT, OS was longer in patients who received prior ET-alone while in ? 2LOT, OS was comparable across prior treatment subgroups.
- Safety and patient-reported outcomes in patients with hormone receptor-positive, HER2-negative advanced breast cancer treated with CDK4/6 inhibitors in China: A cross-sectional study. (Hall A; Poster Bd #: 32) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2484;
Dalpiciclib has the lowest risk of diarrhea and hepatotoxicity based on physicians' reports, and shows the best patient-perceived safety. Regarding QoL, CDK4/6 inhibitors can result in upset by hair loss, while patients have the least concern about this issue when using dalpiciclib, especially for those with long treatment duration (>6 months).
- Ibrance (palbociclib) / Pfizer, H3B-6545 / Eisai
H3B-6545 + palbociclib in patients (pts) with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative ( (Hall A; Poster Bd #: 29) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2481;
P1
H3B-6545 300 mg + palbo (100/125 mg) had manageable safety and encouraging preliminary antitumor activity. Further studies are warranted to identify the RP2D.
- risovalisib (CYH33) / HaiHe Biopharma
A phase Ib study of PI3K? inhibitor risovalisib mesylate in combination with fulvestrant in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer. (Hall A; Poster Bd #: 25) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2478;
P1
Alpelisib (PI3K? inhibitor) + fulvestrant has been approved for pts with PIK3CA-mutated HR+/HER2- ABC following progression on/after an ET-based regimen...A multicenter, open-label, phase Ib study of CYH33 in combination with ET
- Ibrance (palbociclib) / Pfizer
Evaluating metrics of circulating tumor DNA response and progression using a high sensitivity tumor-agnostic assay in metastatic HR+/HER2- breast cancer receiving endocrine therapy and a CDK4/6-inhibitor. (Hall A; Poster Bd #: 21) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2474;
The use of a high sensitivity assay permits assessment of response in nearly all patients and suggests the possibility that radiographic surveillance could be reduced in patients with ctDNA-R. Prospective validation of these findings are required.
- Ibrance (palbociclib) / Pfizer, Keytruda (pembrolizumab) / Merck (MSD)
A phase I/II trial of palbociclib, pembrolizumab, and endocrine therapy for patients with HR+/HER2- locally advanced or metastatic breast cancer (MBC): Clinical outcomes and stool microbial profiling. (Hall A; Poster Bd #: 16) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2469;
P2
Specific gut profiles were associated with response, with similar taxa of bacteria associated with ICI response in other tumor types (2). Enriched metabolic pathways may generate microbiota-derived metabolites that have an immunomodulatory effect.
- Ibrance (palbociclib) / Pfizer
Plasma mutational burden in PIK3CA and TP53 independently predicts early progression in patients with HR+/HER2- metastatic breast cancer (MBC) enrolled in the GEICAM/2014-12 FLIPPER trial. (Hall A; Poster Bd #: 7) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2460;
P2
Enriched metabolic pathways may generate microbiota-derived metabolites that have an immunomodulatory effect. Baseline plasma mutational burden in both PIK3CA and TP53 genes was significantly associated with Fulvestrant +/- Palbociclib treatment outcome in HR+/HER2- MBC and appeared to be predictive of Palbociclib benefit.
- Ibrance (palbociclib) / Pfizer
Use of liquid biomarker thymidine kinase activity (TKa) to predict outcome and progression in patients with metastatic breast cancer (MBC) in the GEICAM/2014-12 FLIPPER trial. (Hall A; Poster Bd #: 6) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2459;
P2
TKa dynamics before and during therapy are associated with PFS and OS. Future studies will provide additional knowledge on the utility of TKa in MBC.
- Ibrance (palbociclib) / Pfizer
Primary results from PATRICIA cohort C (SOLTI-1303), a randomized phase II study evaluating palbociclib with trastuzumab and endocrine therapy in pretreated HER2-positive and PAM50 luminal advanced breast cancer. (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2451;
P2
Pts were randomized 1:1 to Cohort C1 (Palbociclib 125 mg/day orally 3 weeks/1 week off + T + ET) or Cohort C2 (TPC, including T + any ET or chemotherapy (CT) + T, or T-DM1)...In cohort C1, 50% of the pts received fulvestrant and 50% aromatase inhibitor as ET... The combination of palbociclib, T and ET showed a statistically significant improvement in PFS in patients with previously treated PAM50 luminal A or B HER2+ advanced breast cancer, as compared to TPC.
- Ibrance (palbociclib) / Pfizer, inavolisib (GDC-0077) / Roche
First-line inavolisib/placebo + palbociclib + fulvestrant (Inavo/Pbo+Palbo+Fulv) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2?negative locally advanced/metastatic breast cancer who relapsed during/within 12 months (mo) of adjuvant endocrine therapy completion: INAVO120 Phase III randomized trial additional analyses. (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2444;
P2/3
The combination of palbociclib, T and ET showed a statistically significant improvement in PFS in patients with previously treated PAM50 luminal A or B HER2+ advanced breast cancer, as compared to TPC. Inavo+Palbo+Fulv was associated with sustained benefit beyond disease progression, delaying chemotherapy administration, with manageable safety and tolerability that was reflected in PROs; hence, supporting it as a new standard of care.
- Ibrance (palbociclib) / Pfizer
Palbociclib plus exemestane with GnRH agonist vs capecitabine in premenopausal patients with HR+/HER2- metastatic breast cancer: Updated survival results of the randomized phase 2 study Young-PEARL. (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2443;
P2
Young-PEARL study showed exemestane + palbociclib with OFS improves efficacy compared with capecitabine in terms of PFS, which did not lead to an OS benefit for patients with premenopausal HR+/HER2- mBC (median follow-up duration: 54.8 months). The overall safety profile of palbociclib and capecitabine continues to be manageable with longer follow-up.
- Verzenio (abemaciclib) / Eli Lilly
Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial. (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2442;
P3
Prior CDK4/6i was 59% palbociclib, 33% ribociclib, and 8% abemaciclib. Abemaciclib + fulvestrant demonstrated statistically significant PFS improvement in pts with ABC progression on prior CDK4/6i-containing therapy.
- navtemadlin (KRT-232) / Kartos Therap
Pre-clinical modeling of navtemadlin pharmacokinetics (PK), pharmacodynamics (PD), and efficacy in glioblastoma, IDH-wildtype. (E450a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2327;
Targeting nvtm levels based on the in vitroIC50 may significantly underestimate the in vivo effective concentration. In vivo studies showed lower intra-tumoral nvtm levels are required to significantly inhibit growth of MDM2amplified compared with non-amplified tumors.
- Imdelltra (tarlatamab-dlle) / Amgen
Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2316;
P1
Findings from this phase 1 study of tarlatamab in pts with NEPC demonstrated manageable safety with encouraging anti-tumor activity in DLL3 expressing NEPC. Further investigation is ongoing.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors. (Hall A; Poster Bd #: 307a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2135;
P2
The primary endpoint for each cohort is ORR by investigator per RECIST version 1.1. Secondary endpoints include safety and tolerability, DOR, DCR, PFS, overall survival, pharmacokinetics, and the correlation between HER3 IHC protein expression and efficacy.
- BTX-9341 / BioTheryX
Characterization of BTX-9341, a bifunctional degrader of CDK4 and CDK6 for HR+/HER2- breast cancer and glioblastoma multiforme. (Hall A; Poster Bd #: 256) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2083;
BTX-9341, a degrader of CDK4 and CDK6 and inhibitor of CDK2 and Cyclin E transcription, displayed enhanced activity compared to CDK4/6i in breast cancer and GBM in vitro and in vivo. This indicates that a degrader approach to targeting this pathway in breast cancer may be more effective than current therapies, and that BTX-9341 may also be a promising candidate for brain metastases and GBM.
- Kadcyla (ado-trastuzumab emtansine) / Roche
Safety and efficacy of biosimilar TDM-1: A real world retrospective study. (Hall A; Poster Bd #: 167) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1999;
No new adverse events were identified. The safety and efficacy of the biosimilar TDM1 were comparable.