NSCLC stands as a prominent malignancy impacting a substantial portion of the population in both the United States and major European countries. While ASCO 2023 is just around the corner, The leading Pharma players including AstraZeneca, Merck, BMS, Novartis, Dizal Pharma, Amgen, Daiichi Sankyo, etc. are all geared up for this conference to present the data readouts and final analysis. The hype for the session is the unveiling of the first pivotal study results of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR Exon20ins mutations, and the updated results for TROPION-Lung02 trial study in advanced NSCLC (aNSCLC).
NSCLC Highlights
1. Abstract Number – 9002
Title: Groundbreaking Milestone for Dizal’s Oncology Portfolio : Unveiling the First Pivotal Study Results
Main Content - The primary objective behind the development of Sunvozertinib was to overcome the constraints posed by current therapies for NSCLC. According to the findings, the patients treated with sunvozertinib (n = 97) achieved a confirmed objective response rate (cORR) of 60.8%. Apart from that, Significant anti-tumor effectiveness was observed in diverse EGFR Exon20ins subtypes, showcasing its broad-ranging impact. Additionally, patients with pre-existing brain metastases who had undergone prior treatment experienced positive tumor responses as well. Lastly, the above findings indicates that sunvozertinib holds promise as a viable and well-tolerated therapeutic choice to address this prevailing medical need. Rest, wait for the updated results of WU-KONG6 to be unveiled during the conference.
2. Abstract Number - 9004
Title – Novartis is set to present the updated safety and efficacy data of JDQ443 in KRAS G12C-mutated solid tumors including NSCLC (KontRASt-01)
Main Content – According to DelveInsight, around 30% of NSCLC cases have KRAS mutations in the United States, followed by 25% in Europe and 15% in Japan. Additionally, the most common mutation present in the current scenario is G12C.
JDQ443 is an investigational covalent KRAS G12C inhibitor derived from a structure-based drug design followed by extensive optimization of two dissimilar prototypes. In preclinical models, JDQ443 potently inhibited KRAS G12C cellular signaling and proliferation in a mutant-selective manner and demonstrated dose-dependent antitumor activity. Earlier, in April 2022, the company released the preliminary data on KontRASt-01. According to the findings, at data cutoff January 05, 2022, from the pooled Phase Ib JDQ443 single-agent cohort (n = 39) showed 57% confirmed the overall response rate (ORR) at 200 mg BID in NSCLC. Additionally, the drug also demonstrated antitumor activity, high systemic exposure at its recommended dose, and a favorable safety profile based on initial clinical data in patients with KRAS G12C-mutated solid tumors. The company is also evaluating JDQ443 in combination with trametinib, ribociclib, cetuximab (KontRASt-03) for the treatment of advanced solid tumors. So let’s wait for the full set of data to be announced during the conference.
Company |
Drug |
Trial Acronym |
Phase |
Abstract No. |
Abstract Title |
Merck |
Pembrolizumab |
KEYNOTE-789 |
III |
#LBA9000 |
Pemetrexed and platinum with or without pembrolizumab for tyrosine kinase inhibitor (TKI)-resistant, EGFR-mutant, metastatic nonsquamous NSCLC: Phase 3 KEYNOTE-789 study |
BMS |
Nivolumab |
CheckMate 9LA |
III |
#LBA9023 |
First-line (1L) nivolumab (N) + ipilimumab (I) + chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4‑y clinical update and outcomes by tumor histologic subtype (THS) |
AstraZeneca |
Osimertinib |
ADAURA |
III |
#LBA3 |
Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR‑mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC) |
Merck |
Pembrolizumab |
KEYNOTE-671 |
III |
#LBA100 |
KEYNOTE-671: Randomized, double-blind, phase 3 study of pembrolizumab or placebo plus platinum-based chemotherapy followed by resection and pembrolizumab or placebo for early stage NSCLC |
Amgen |
Sotorasib |
CodeBreak 200 |
III |
#LBA9016 |
Intracranial efficacy of sotorasib versus docetaxel in pretreated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC): Practice-informing data from a global, phase 3, randomized, controlled trial (RCT) |
Dizal Pharma |
Sunvozertinib |
DZ2020E0001 |
II |
#9002 |
Sunvozertinib for the treatment of NSCLC with EGFR Exon20 insertion mutations: The first pivotal study results |
Novartis |
JDQ443 |
KontRASt-01 |
Ib/II |
#9007 |
KontRASt-01 update: Safety and efficacy of JDQ443 in KRAS G12C-mutated solid tumors including non-small cell lung cancer (NSCLC) |
AstraZeneca |
AZD2936 |
ARTEMIDE-01 |
I/II |
#9050 |
Safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of AZD2936, a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)- experienced advanced/metastatic NSCLC: First report of ARTEMIDE-01 |
Merck |
SKB264 (MK-2870) |
A264 |
I/II |
#9114 |
SKB264 (TROP2-ADC) for the treatment of patients with advanced NSCLC: Efficacy and safety data from a phase 2 study |
Daiichi Sankyo |
Datopotamab deruxtecan |
TROPION-Lung02 |
Ib |
#9004 |
TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) in advanced non-small cell lung cancer (aNSCLC) |