ctDNA Technology: A Game Changer
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed.
ctDNA technology a game changer
At this year’s ASCO conference, circulating tumor DNA (ctDNA) was at the center of attention. Though various technological challenges need to be tackled first for full-fledged commercialization, a variety of ctDNA screening techniques were presented at poster sessions for several cancer types. In our view, ctDNA technology is likely to become an all-purpose tool throughout all phases of cancer treatment, from early detection to companion diagnostics, metastasis diagnostics, and prognostic tests. Given its superior efficacy in early detection, it appears likely that ctDNA technology will be a game changer in the treatment of human diseases. Going forward, we advise investors to establish strategies regarding this emerging field, taking account of the following: 1) forward-looking clinical study results; 2) in-house patents (such as next-generation sequencing technologies); 3) global targeting; and 4) commercialization strategies.
Standing ovation for ADC technology
Grabbing the most attention at the 2022 ASCO meeting were data on the DESTINY-Breast04 study result for AstraZeneca (Daiichi Sankyo)’s third-gen ADC drug Enhertu (trastuzumab deruxtecan) targeting HER2-low metastatic breast cancer. With no effective second-line advanced breast cancer treatment currently available for HER2-low patients, the DESTINY-Breast04 study result is being welcomed as a ground-breaking achievement. In addition to the already-maturing breast cancer market, we advise investors to pay attention to new ADC markets, including MET bispecific antibody. In particular, the role of ADC looks promising in the non-small cell lung cancer (NSCLC) arena, especially in terms of EGFR-mutant NSCLC.
Draw attention to Mirati’s KRAS inhibitor data on brain metastasis
After it presented an ASCO abstract showing a shorter reaction duration and disappointing progression free survival (PFS) for its KRAS inhibitor Adagrasib compared to Lumakras, Mirati saw its share price decline. But, its share price soon recovered on the release of encouraging data related to brain metastasis at the main ASCO session. The PDUFA target date for Adagrasib is Dec 14. Despite lingering uncertainties due to the already-approved Lumakras, FDA approval now seems more likely than before, given Mirati’s meaningful brain metastasis-related data update.
Competition intensifying for EGFR mutation NSCLC treatments
The EGFR mutation NSCLC market, known for Lazertinib, is still booming. In the past, EGFR exon 19/21 mutations (Tagrisso) were at the center of the market, but at this year’s ASCO meeting, a range of clinical trial data on EGFR exon 20 mutation and MET exon14 mutation were also disclosed, including antibody drugs and ADC technology.
Blood cancer: Bispecific antibody and CAR T-cell therapies
In the blood cancer session, bispecific antibody and CAR T-cell therapies received attention. The keys for blood cancer treatments are overall response rate (ORR) and reaction duration. We advise paying attention to Roche’s Glofitamab and AbbVie’s Epcoritamab, which are CD20xCD3 T-cell engaging bispecific antibodies for DLBCL. As for CAR T-cell therapy, encouraging data were presented by Adicet for its gamma delta CAR T-cell therapy ADI-001 and by Arcellx for ddBCMA. Of note, these two firms demonstrated the strongest share price performance among ASCO attendees around the meeting dates.