Insights+ Key Events of ASCO 2019

Key Events of ASCO 2019


The American Society of Clinical Oncology (ASCO) is a platform for cancer experts to share views on latest advancement and new approaches in cancer research. In the 55th session of ASCO 2019, 2400+ abstracts were presented. IBM Watson Health was also a part of ASCO 2019 with its advancement in Oncology, Genomics and Patient Monitoring. The top Pharma companies like Roche, Merck has presented their data. Our team at PharmaShots has summarized and complied the key events of ASCO 2019.

1. Janssen (J&J) Reports Results of Erleada (apalutamide) in P-III TITAN Study for Metastatic Castration-Sensitive Prostate Cancer (mCSPC) #ASCO2019

 Date- May 31, 2019

Products- Erleada, Apalutamide

The P-III TITAN study involves assessing of Erleada + Androgen Deprivation Therapy (ADT) vs PBO + ADT in 1050 patients in ratio 1:1 with mCSPC across 23 countries.The P-III study results: @22.7 mos. OS (82% vs 74%); PSA (68% vs 29%); 52% reduction in risk of radiographic progression; 61% reduction in time to cytotoxic CT; 34% reduction in PFS2. Erleada (apalutamide) is an androgen receptor (AR) inhibitor and has received FDA approval for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) on 14 Feb,2018. The results of P-III TITAN study will accelerate the approval of Erleada for mCSPC.

2. AstraZeneca and Merck Report Result of Lynparza (olaparib) in P-III POLO Trial for BRCA-Mutated Metastatic Pancreatic Cancer #ASCO2019

 Date- Jun 3, 2019

Products- Lynparza, Olaparib

The P-III POLO study involves assessing of Lynparza (olaparib, 300mg, bid) vs PBO in 154 patients in ratio (3:2) with BRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line Pt-based CT. The P-III POLO study results: improvement in PFS (7.4 vs 3.8 mos.); @1yr & 2yrs. no disease progression (34% & 22% vs 15% & 10%) respectively. Lynparza (olaparib) is a PARP inhibitor targeted for DNA damage response (DDR) pathway deficiencies, including BRCA mutations. In 2017, Merck and AstraZeneca collaborated to co-develop and co-commercialize Lynparza globally.

3. IBM Watson Health Reports Real-World Progress of AI in Oncology in #ASCO2019

Date- May 30, 2019

Products- Oncology

IBM Watson has presented 22 new scientific studies showing progress in clinical studies of cancer using AI-Technology with informed decisions based on curated scientific evidences, insights and information which are unidentified manually and further leading to QoL .The presented data includes: Watson For Oncology lead to 13.6% changes in informs clinical decision reviewed by multidisciplinary tumor board; Watson For Genomics Surfaces resulted in new insights for oncologists to treat hematological malignancies; Watson For Oncology improves cancer patient confidence. Additionally, IBM Watson reported to identify automatically, high-quality and relevant scientific publications with the help of machine learning on words from abstracts of papers cited at three expert resources: NCCN, NCI-PDQ, and Hemonc.org further resulting in 93% accuracy, 95% sensitivity, and 91% specificity of treatment

4. Astellas and Seattle Genetics Report Results of Enfortumab Vedotin in P-II EV-201 Study for Patients with Locally Advanced or Metastatic Urothelial Cancer #ASCO2019

Date- Jun 3, 2019

Products- Enfortumab Vedotin

The P-II EV-201 study involves assessing of Enfortumab Vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor including those who have also been treated with Pt-CT. P-II EV-201 results: ORR 44%; DOR 7.6 mos.; mOS 11.7 mos.; mPFS 5.8 mos.; CR 12%; presented at ASCO 2019. Enfortumab vedotin is an investigational ADC candidate targeting Nectin-4 protein, currently evaluated in P-III EV-301 study for LA or metastatic urothelial cancer. In 2007, Seattle and Astellas entered a co-development deal for enfortumab vedotin, plans to submit BLA to FDA based on EV-201 results

5.AstraZeneca and Merck Report Results of Lynparza (olaparib) in P-III SOLO3 Study for Platinum-Sensitive Relapsed Germline BRCA-mutated Advanced Ovarian Cancer #ASCO2019

Date- Jun 3, 2019

Products- Lynparza, olaparib

The P-III SOLO3 study results involves assessing of Lynparza (300mg, bid) vs CT (paclitaxel/topotecan /pegylated liposomal doxorubicin/gemcitabine) in 266 patients in a ratio (2:1) with 2L+ platinum-sensitive relapsed BRCA1/2-mutated (gBRCAm) advanced ovarian cancer. The P-III SOLO3 study results: improvement in ORR (72.2% vs 51.4%); PFS (13.4 mos. vs 9.2mos.); safe & tolerable, presented at ASCO 2019. Lynparza is a PARP inhibitor, targeted for DNA damage response (DDR) pathway deficiencies, including BRCA mutations and has received approval in 64 & 38 countries as a maintenance treatment of platinum-sensitive relapsed ovarian cancer & 1L gBRCAm HER2- metastatic breast cancer respectively.

6. Novartis Reports Result of Kisqali (ribociclib) + Endocrine Therapy in P-III MONALEESA-7 Study for HR+/HER2- Advanced Breast Cancer #ASCO2019

 Date- Jun 3, 2019

Products- Kisqali, Ribociclib

The P-III MONALEESA-7 study results involves assessing of Kisqali in combination with endocrine therapy (goserelin + aromatase inhibitor/tamoxifen) vs endocrine therapy as monothx. in pre- and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer. The P-III MONALEESA-7 study resulted in improving survival rate @42mos. (70.2% vs 46.0%), 30%/20.9% reduction in risk of death, no new safety signals were observed, presented at ASCO 2019 respectively. Kisqali is the CDK4/6 inhibitor, currently evaluated in P-III NATALEE study with endocrine therapy as an adjuvant treatment of HR+/HER2- early breast cancer and is approved in 75+ countries including the US & EU for the same indication.

7. Sanofi Reports Results of Isatuximab Combination Therapy in P-III ICARIA-MM Study for Relapsed/Refractory Multiple Myeloma #ASCO2019

Date- Jun 3, 2019

Products- Isatuximab

The P-III ICARIA-MM study results involve assessing of Isatuximab (10mg/kg, qw) + pomalidomide and dexamethasone (pom-dex) vs pom-dex in 307 patients with r/r multiple myeloma across 24 countries.    The P-III ICARIA-MM study result: improvement in m-PFS (11.53mos. vs 6.47 mos.); ORR (60% vs 35%); VGPR rate (31.8% vs 8.5%); DOR (13.27mos. vs 11.07mos); median time to first response (35 days vs 58 days), presented at ASCO 2019 in Chicago. Isatuximab is a mAb targeting specific epitope on the CD38 receptor, designed to promote apoptosis & immunomodulatory activity, currently being evaluated in multiple P-III studies for multiple myeloma. EMA has accepted its MAA in Q2’19 and Sanofi has also filed FDA’s BLA for RRMM.

8. Puma Biotechnology Reports Results of PB272 (neratinib) in P-III NALA Trial for Patients with 2L+ HER2+ Metastatic Breast Cancer #ASCO2019 

Date- Jun 4, 2019

Products- PB272, Neratinib, Capecitabine, Tykerb, Lapatinib

The P-III NALA trial involves assessing of neratinib + capecitabine vs Tykerb (lapatinib) + capecitabine in 621 patients in ratio (1:1) with 3L HER2-positive metastatic breast cancer. P-III NALA Trial results: mPFS (8.8 mos. vs 6.6 mos.); mOS (21.0 mos. vs 18.7 mos.); mean OS @48 mos. (24.0 mos. vs 22.2 mos.); overall cumulative incidence of CNS metastases (22.8% vs 29.2%); DOR (8.54 mos. vs 5.55 mos.); TEAEs (10.9% vs 14.5%). PB272 is a tyrosine kinase inhibitor and its oral formulation has received the US FDA’s approval for the extended adjuvant treatment in adults with early stage HER2-overexpressed/amplified breast cancer in Jul’17, marketed as Nerlynx (neratinib) tablets in the US.

9. Roche Reports Results of Venclexta/Venclyxto (venetoclax) in P-III CLL14 Study for Chronic Lymphocytic Leukemia #ASCO2019  

Date- Jun 4, 2019

Products- Venclexta/Venclyxto, Venetoclax, Gazyva/Gazyvar

The P-III CLL14 Study involves assessing of Venclexta/Venclyxto + Gazyva/Gazyvar vs Gazyva/Gazyvaro + chlorambucil in 432 patients with previously untreated chronic lymphocytic leukemia (CLL). P-III CLL14 Study results: ORR (84.7% vs 71.3%); CR (49.5% vs 23.1%); patients receiving Venclexta/Venclyxto lived longer; disease progression @2yrs. (88.2% vs 64.1%); no new safety signals observed. Venclexta/Venclyxto is a drug targeted for binding & inhibiting BCL-2 protein, further leads to apoptosis and has received 5 times FDA’s BT designation in combination or monothx with approval in 50+ countries. Roche and AbbVie collaborated to develop Venclexta/Venclyxto.

10. Novartis Reports Results of Capmatinib in P-II GEOMETRY mono-1 Study for Non-Small Cell Lung Cancer with MET exon-14 Skipping Mutation #ASCO201

Date- Jun 4, 2019

Products- Capmatinib

The P-II GEOMETRY mono-1 study results involves assessing of Capmatinib (400mg, bid) in 97 treatment-naive & prior treated patients with LA/metastatic NSCLC harboring a MET exon-14 skipping mutation.    The P-II GEOMETRY mono-1 study results:  ORR based on BIRC assessment / RECIST v1.1 (68% & 41%); DOR (11.14 mos. & 9.72 mos.), 54% patients showed intracranial activity, presented at ASCO 2019.  Capmatinib (INC280) is an oral & selective MET inhibitor, licensed by Novartis from Incyte Corporation in 2009 and has received FDA’s BT designation for m-NSCLC with MET exon-14 skipping mutation. Additionally, Novartis presents data of canakinumab (ACZ885) as monothx. in P-III CANOPY study for mid- to late-stage NSCLC.

Note- This insight report is a compilation of ASCO2019 associated news published by PharmaShots in chronological order

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