ASCO 2022: Top 10 Most Anticipated Breast Cancer Studies

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Very interesti.

Randomized Phase III clinical trial:

To evaluate the efficacy of sacituzumab govitecan versus physician's choice of treatment in patients with HR+/HER2- advanced breast cancer

Speaker: Hope Rugo

Abstract ID: LBA1001

Why it's on the list: Could registry data in HR-positive breast cancer add to another indication for goxatuzumab in addition to triple-negative breast cancer?

Additional information:

On March 7, 2022, Gilead announced that a phase III clinical trial of goxatuzumab in patients with HR+/HER2- metastatic breast cancer who had received multiple treatments met the primary endpoint without progressi.

Currently, Goxatuzumab is approved for second-line treatment of metastatic triple-negative breast cancer in many countries around the wor.

In May 2021, CDE accepted the marketing application of goxatuzumab for the treatment of triple-negative breast cancer and included it in priority revi.

The MAINTAIN study, a randomized phase II clinical trial:

To evaluate the progression of antiestrogen therapy in combination with CDK4/6 inhibitors, fulvestrant, or exemestane with or without ribociclib in patients with HR+/HER2- metastatic breast cancer

Speaker: Kevin Kalinsky

Abstract ID: LBA1004

Why it's on the list: This is the first high-quality data on continued use of a CDK4/6 inhibitor after progression on a CDK4/6 inhibit.

Additional information:

There are currently no high-quality evidence-based data on regimens following failure of CDK4/6 inhibitor thera.

The exploration of clinical research can be roughly divided into 4 categories:

Continue to use CDK4/6 inhibitors and replace endocrine drugs;To maintain endocrine therapy, other CDK4/6 inhibitors or other targeted drugs can be replaced;Maintain CDK4/6 inhibitors and endocrine therapy, increase bypass Another drug targeting the pathway;Other clinical trials of new dru.

Cavity study:

A prospective study of deradiation therapy after breast-conserving surgery for T1N0 intraluminal type A breast cancer

Speaker: Timothy Whelan

Abstract ID: LBA501

Why it's on the list: Will this change the standard of care for T1N0 intraluminal breast cancer?

Additional information:

Adjuvant radiotherapy (RT) is currently the standard regimen after breast-conserving surgery for patients with early-stage invasive breast canc.

But some patients have a lower risk of recurrence, is there a screening method that would spare them from radiation therapy?

At the 2021 ASCO meeting, Abstract 512 further stratified the patient population of the SweBCG91 study and screened for a 16-gene signature, named POLAR, indicating that POLAR low-risk patients had no apparent benefit from radiotherapy, expected There will be more data from clinical trial studi.

HER3 ADCs-Patritumab deruxtecan for HER3-expressing metastatic breast cancer patients with phase I/II study results:

Speaker: lan Krop

Abstract number: 1002

Why it's on the list: ADCs are too hot right now, HER3 ADCs may have a similar story to HER2 ADCs (T-DXd), should we be cooler?

Additional information:

The high expression of HER3 is closely related to tumor occurrence, development and prognosis of patien.

Patritumab deruxtecan (HER3-DXd, U3-1402) is currently the only HER3-ADC that has entered Phase II clinical tria.

KEYNOTE-522: Exploratory Analysis of Event-Free Survival (EFS) Outcomes of Pembrolizumab + Chemotherapy vs Placebo + Chemotherapy in Neoadjuvant Treatment of Early Triple-Negative Breast Cancer:

Speaker:Lajos Pusztai

Summary Number: 503

Why it's on the list: Pathological complete response (pCR) may not be sufficient to assess prognosis, and residual tumor burden (RCB) may be a better risk indicat.

Additional information:

The primary endpoints of the KEYNOTE-522 study were pCR and E.

The first interim analysis showed that in patients with early-stage TNBC, pCR was significantly higher in patients with pembrolizumab plus neoadjuvant chemotherapy than in patients with placebo plus neoadjuvant chemothera.

In February, the New England Journal of Medicine NEJM published EFS results from the KEYNOTE-522 stu.

However, a single study alone cannot confirm pCR as a biomarker for early prognosis in TNBC, especially as a meta-analysis published in the British Medical Journal (BMJ) in 2021 showed that pCR is not a substitute for disease-free survival and overall surviv.

As such, the authors of KEYNOTE-522 noted in a previous article that molecular biomarker research is still ongoi.

Analysis of the PALOMA-2 study: palbociclib + letrozole versus placebo + letrozole in first-line treatment of women with ER+/HER2 advanced breast cancer overall survival (OS)

Speaker: Richard Finn

Abstract ID: LBA1003

Why it's on the list: OS data for first-line palbociclib therapy have been missing in the pa.

Additional information:

At present, palbociclib has only obtained OS data in the phase II clinical trial PALOMA-1 study, and OS was prolonged but not statistically significa.

Median OS for palbociclib + letrozole vs letrozole was 35 months vs 33 months (HR=813, 95%Cl 492-345, P[bilateral]=4

In the past, PALOMA-2 has only released PFS results, so I'm looking forward to the final OS resul.

It is not known whether palbocoxib can further verify its effectivene.

Analysis of FAKTION research:

Added OS data and updated PFS data for biomarker stratification analys.

The FAKTION study was designed to evaluate the efficacy of fulvestine + Capivasertib versus fulvestine + placebo in patients with ER+ advanced breast cancer after progression on aromatase inhibitor therapy

Speaker: Robert Jones

Abstract number: 1005

Reasons for listing: single-agent furosemide has unsatisfactory effica.

Can Capivasertib improve efficacy in patients with ER+ advanced breast cancer?

Additional information:

Capivasertib is the world's first AKT inhibitor to enter clinical phase III development, and its indications are mainly focused on HR+ breast cancer, triple-negative breast cancer and prostate canc.

Capivasertib previously achieved positive results in the PAKT study, a Phase II clinical trial in patients with metastatic triple-negative breast canc.

Capivasertib combined with paclitaxel in first-line treatment of triple-negative breast cancer significantly prolongs PFS in patien.

In 2020, AstraZeneca announced preliminary results from the FAKTION stu.

Results of the study showed that patients randomized to fulvestrant plus capivasertib (n=69) had significantly longer mPFS (13 vs 8 m) and decreased disease progression compared to fulvestrant plus placebo (n=71) (n=71), with a risk of 42% (HR=58, 95%CI 39-84), meeting the primary endpoint of the stu.

Randomized Phase III DESTINY-Breast03 Study:

Safety follow-up of T-DXd and T-DM1 in patients with HER2+ unresectable and/or metastatic breast cancer

Speaker:Erika.

Hamilton

Summary: 1000

Why it's on the list: T-DXd is a second-line drug in the current standard of ca.

Moving forward, how tolerable and safe is T-DXd?

Additional information:

The safety results of the previous DESTINY-Breast03 study showed that the incidence of drug-related adverse events of any grade in the T-DXd and T-DM1 groups was 91% and 86%, respectively, and the incidence of grade 3 or 4 drug-related adverse even.

The incidence rates were 41% and 38%, respective.

Drug-related interstitial disease or noninfectious pneumonia occurred in 15% and 9% of patients in the T-DXd group and T-DM1 group, respectively, but no grade 4-5 drug-related interstitial disease or noninfectious disease occurr.

pneumon.

Effects of Ribociclib Dose Adjustment on OS Outcomes in HR+/HER2- Advanced Breast Cancer in the MONALEESA-2 Study:

Speaker:Lowell Hart

Abstract ID: 1017

Poster number: 39

Why on the list: Do dose reductions affect key outcome data? I'd say .

Additional information:

In March of this year, NEJM officially released the OS data of the MONALEESA-2 study after nearly seven years of tracki.

Median OS for ribociclib + letrozole vs placebo + letrozole was 69 months vs 54 months (HR = 76; 95% CI 63 - -93; two-sided P = 008)

1 NeoSTAR research results:

A phase II study of goxatuzumab neoadjuvant therapy in localized triple-negative breast cancer

Laura Spring

Summary: 512

Poster number: 284

Reason for listing: Exploring ADC advancement to the neoadjuvant sta.

Additional information:

The ASCENT study of goxatuzumab confirmed its efficacy in metastatic TNBC and was approved for second-line treatment of metastatic TNBC in several countries around the wor.

Currently, goxatuzumab is also actively explored in the first-line treatment of TNBC as well as in the neoadjuvant and adjuvant treatment of early-stage TNBC (NeoSTAR study and SASCIA stud.

(Source: Internet, reference only)