Molecular Diagnostics in Clinical Oncology
Top 10 Lung Cancer Advances Of 2024
Significant advancements in lung cancer treatment were seen throughout 2024, from new drug approvals to promising clinical trial results.
Lung cancer: © Crystal Light - stock.Adobe.Com
Significant advancements in lung cancer treatment were seen throughout 2024, from new drug approvals to promising clinical trial results. Here are some of the top developments covered by Targeted OncologyTM, highlighting the progress in targeted therapies and improved patient outcomes.
FDA Approval of Ensartinib for ALK-Positive NSCLC: The FDA approved ensartinib for the first-line treatment of patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. This decision was supported by findings from the phase 3 eXalt3 trial (NCT02767804), which demonstrated a median progression-free survival (PFS) of 25.8 months with ensartinib compared with 12.7 months with crizotinib (Xalkori).
FDA Approves Tarlatamab in Small Cell Lung Cancer: In May 2024, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra), a bispecific T-cell engager (BiTE), for small cell lung cancer (SCLC) that has progressed after platinum-based chemotherapy, based on results from the phase 2 DeLLphi-301 study (NCT05060016). This approval makes tarlatamab the first BiTE therapy approved for a major solid tumor.
FDA Complete Response Letter for SC Amivantamab BLA in EGFR+ NSCLC: The FDA issued a complete response letter (CRL) for the biologics license application (BLA) for subcutaneous amivantamab-vmjw (Rybrevant) with recombinant human hyaluronidase, covering all approved or submitted indications for intravenous amivantamab in select patients with NSCLC. According to Johnson & Johnson, the CRL pertains to manufacturing inspection issues, not the product's formulation, efficacy, safety, or the need for additional clinical studies.
Amivantamab Boosts OS in EGFR-Mutant NSCLC After Osimertinib: Longer-term follow-up from the MARIPOSA-2 trial (NCT04988295) continues to demonstrate improved overall survival (OS) with amivantamab combined with chemotherapy compared with chemotherapy alone in patients with EGFR-mutant advanced NSCLC who experienced disease progression on osimertinib (Tagrisso). These findings, based on a median follow-up of 18.1 months, were presented at the 2024 ESMO Congress.
FDA ODAC Unanimously Calls for Phase Assessments in NSCLC Perioperative Regimens: In a unanimous 11 to 0 vote, the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA require new trial designs for perioperative regimens in resectable NSCLC to include thorough assessments of the contribution of each treatment phase.
FDA Grants Full Approval to Tepotinib in NSCLC: In February 2024, tepotinib (Tepmetko) was FDA-approved for patients with NSCLC with mesenchymal-epithelial transition (MET) exon 14 skipping alterations. The approval was supported by findings from the VISION trial (NCT02864992).
FDA Grants Zongertinib Breakthrough Designation in HER2-Mutant NSCLC: Zongertinib (BI 1810631), an investigational oral therapy, received breakthrough therapy designation from the FDA in August 2024. The agent also received breakthrough therapy designation from China's Center for Drug Evaluation for adult patients with advanced, unresectable or metastatic NSCLC with activating HER2 mutations.
New BLA Submitted for Dato-DXD in EGFR-Mutant NSCLC: A new BLA was submitted specifically for EGFR-mutated NSCLC after FDA feedback, replacing the earlier nonsquamous NSCLC application. This application draws from phase 2 and phase 3 data in the TROPION-Lung01 (NCT04656652), TROPION-Lung05 (NCT04484142), and TROPION-PanTumor01 (NCT03401385) trials.
Osimertinib Improves PFS in Stage III EGFR+ NSCLC: Osimertinib demonstrated statistically significant and clinically meaningful improvements in PFS for the treatment of unresectable, stage III EGFR-mutant NSCLC following chemoradiotherapy, compared with placebo, according to results from the phase 3 LAURA trial (NCT03521154). This marks the first EGFR inhibitor and targeted therapy to show PFS benefits in patients with stage III disease.
FLAURA2 Analysis Extends Osimertinib Combo Benefit in NSCLC: The second interim analysis of the phase 3 FLAURA2 study (NCT04035486) showed encouraging trends for osimertinib combined with platinum-pemetrexed chemotherapy over osimertinib monotherapy in EGFR-mutant advanced NSCLC. The combination arm had a median OS not reached vs 36.7 months with osimertinib alone (HR, 0.75; P = .028), and also showed favorable outcomes for post-progression measures.
These developments represent significant strides in lung cancer research and treatment, offering hope for improved patient outcomes and survival rates.
J&J Says Cancer Drug Combination Showed Survival Benefit Over Tagrisso
Dive Brief:Tuesday's disclosure from J&J is a summary; full results won't be available until an "upcoming medical meeting." The company also plans to share them with health regulators.
Still, the finding J&J has claimed is notable. Tagrisso has become a top-selling cancer drug due to its extensive use treating non-small cell lung tumors harboring mutations in a gene known as EGFR. In a study called FLAURA, AstraZeneca showed Tagrisso treatment led to median overall survival of nearly 39 months.
J&J described the survival improvement it observed in Mariposa as "clinically meaningful and statistically significant," meeting the study's final pre-specified secondary goal.
While Rybrevant and Lazcluze are already approved for use in non-small cell lung cancer, the overall survival benefit J&J is reporting may convince more physicians to use the regimen over Tagrisso. Prior data showed the combination reduced the risk of cancer progression or death by 30% versus Tagrisso alone, but extending survival is considered more definitive evidence for a new cancer drug.
Still, physicians will have to weigh the treatments' relative safety profiles. In Mariposa, 10% of people given Rybrevant and Lazcluze stopped therapy due to side effects, compared to 3% of those on Tagrisso. The combination was also associated with a type of blood clot that forms in veins, prompting the FDA to require preventive anticoagulation during the first months using J&J's regimen.
AstraZeneca has also shown in further testing that adding chemotherapy to Tagrisso can improve on the benefit offered by Tagrisso alone. That addition comes with additional safety concerns of its own, however, and hasn't yet been proven to extend survival.
Rybrevant is a bispecific antibody that binds to two different types of proteins, called EGFR and MET. Lazcluze is an oral drug aimed at EGFR, and works by inhibiting an enzyme that can transform normal cells into cancerous ones.
They're approved in the U.S. And Europe for use together as first-line treatment of locally advanced or metastatic non-small cell lung cancer with certain mutations in which pieces of DNA have been deleted or substituted.
PM-8002 By Biotheus For Small-Cell Lung Cancer: Likelihood Of Approval
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
PM-8002 overviewPM-8002 is under development for the treatment of solid tumors, neuroendocrine tumors, such as small cell lung cancer, non-small cell lung cancer, hepatocellular carcinoma, malignant pleural mesothelioma, hormone receptor positive and/or HER2-positive breast cancer, triple-negative breast cancer (TNBC), metastatic hepatocellular carcinoma, platinum-resistant ovarian cancer, cervical cancer and renal cell carcinoma. The therapeutic candidate is a bi-specific monoclonal antibody. It is administered through intravenous and intravenous drip route. It acts by targeting PDL1 and VEGF A.
Biotheus overviewBiotheus is a clinical-stage biotech company that discovers, develops and delivers novel antibodies for oncology and inflammatory disease treatment. The company's pipeline products include PM8002, PM8001, PM1015, PM1086, PM1003, PM1009, PM1022, PM1032, PM1130, PM1080, PM1092 and multiple ADCS. The company's PM8002 is a next-generation PD-(L)1-based bispecific that blocks the PD-L1 and VEGF pathways and PM1009 is a next-generation checkpoint inhibitor to the PVR-TIGIT axis by inhibiting two non-redundant checkpoints TIGIT and PVRIG that targets tumors. The company operates through its subsidiaries in China and Hong Kong. Biotheus is headquartered in Zhuhai, Guangdong, China.
For a complete picture of PM-8002's drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData's Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData's Pharmaceutical Intelligence Center.
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