Table Info

Table 1.

Major achievements in clinical outcomes for patients with druggable genetic alterations

Gene/Mutation	Drug	Study	Number of patients	Response rate	PFS	OS	Reference	Brief description of the study
EGFR ex19del and L858R	Osimertinib	NCT02296125 (FLAURA)	279, treatment-naive	80%	18.9 months	38.6 months	[11]	Phase III, osimertinib vs. 1st-generation TKI
	Osimertinib + chemotherapy	NCT04035486 (FLAURA2)	279, treatment-naive	83%	29.4 months	Not reached	[14]	Phase III, osimertinib plus chemotherapy vs. osimertinib alone
	Erlotinib + ramucirumab	NCT02411448 (RELAY)	224, treatment-naive	76%	19.4 months	Not reached	[15]	Phase III, erlotinib plus ramucirumab vs. erlotinib alone
EGFR exon 20 insertions	Amivantamab	NCT02609776 (CHRYSALIS)	81, previously treated	40%	8.3 months	22.8 months	[16]	Phase I
ERBB2 (HER2) mutations	Trastuzumab deruxtecan (T-DXd)	NCT04644237 (DESTINY-Lung02)	152, previously treated	49% (5.4 mg/kg); 56% (6.4 mg/kg)*	9.9 months (5.4 mg/kg); 15.4 months (6.4 mg/kg)*	19.5 months (5.4 mg/kg); not reached (6.4 mg/kg)*	[17]*	Phase II, comparison of two drug doses
BRAF V600 mutations	Dabrafenib + trametinib	NCT01336634	36, treatment-naive	64%	10.9 months	17.3 months	[18]	Phase II
BRAF V600 mutations	Encorafenib + binimetinib	NCT03915951	59, treatment-naive	75%	Not reached	Not reached	[19]	Phase II
KRAS G12C	Sotorasib	NCT04303780 (CodeBreak 200)	141, previously treated by chemotherapy and ICI	28%	5.6 months	10.6 months	[20]	Phase III, sotorasib vs. docetaxel
KRAS G12C	Adagrasib	NCT03785249 (KRYSTAL-1)	112, previously treated by chemotherapy and ICI	43%	6.5 months	12.6 months	[21]	Phase I−II
MET exon 14 skipping mutations	Capmatinib	NCT02414139 (GEOMETRY)	28, treatment-naive	68%	12.4 months	20.8 months	[22]	Phase II
MET exon 14 skipping mutations	Tepotinib	NCT02864992 (VISION)	164, treatment-naive	57%	12.6 months	21.3 months	[23]	Phase II
ALK fusions	Alectinib	NCT02075840 (ALEX)	152, treatment-naive	83%	34.8 months	Not reached	[24]	Phase III, alectinib vs. crizotinib
ALK fusions	Lorlatinib	NCT03052608 (CROWN)	149, treatment-naive	76%	Not reached (above 3 years)	Not reached	[25]	Phase III, lorlatinib vs. crizotinib
ROS1 fusions	Crizotinib	NCT00585195 (PROFILE 1001)	53, previously treated and treatment-naive	72%	19.3 months	51.4 months	[26]	Phase I
	Entrectinib	NCT02097810 (STARTRK-1), NCT02568267 (STARTRK-2), EudraCT, 2012-000148-88 (ALKA-372-001)	168, previously treated (without TKI) and treatment-naive	68%	15.7 months	47.8 months	[27]	Phase I−II
	Repotrectinib	NCT03093116 (TRIDENT-1)	71, treatment-naive	79%	35.7 months	Not reached	[28]	Phase I−II
RET fusions	Pralsetinib	NCT04222972 (ARROW)	75, treatment-naive	72%	13.0 months	Not reached	[29]	Phase I−II
RET fusions	Selpercatinib	NCT04194944 (LIBRETTO-431)	129, treatment-naive	84%	24.8 months	Not reached	[30]	Phase III, selpercatinib vs. pembrolizumab plus chemotherapy
NTRK fusions	Entrectinib	NCT02097810 (STARTRK-1), NCT02568267 (STARTRK-2), EudraCT, 2012-000148-88 (ALKA-372-001)	51, previously treated and treatment-naive	63%	28.0 months	41.5 months	[31]	Phase I−II
NTRK fusions	Larotrectinib	NCT02576431 and NCT02122913	20, previously treated	73%	35.4 months	40.7 months	[32]	Phase I−II

* Significantly higher incidence of severe adverse event at higher dose of the drug. PFS: progression-free survival; OS: overall survival; ICI: immune checkpoint inhibitor; TKI: tyrosine kinase inhibitor

Declarations

Acknowledgments

We are cordially thankful to Dr. Priscilla Amankwah for her invaluable help in improving this manuscript.

Author contributions

ENI: Conceptualization, Investigation, Writing—original draft, Writing—review & editing, Supervision. EVP: Investigation, Visualization, Writing—review & editing. SVO: Validation, Writing—review & editing. All authors read and approved the submitted version.

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

This research has been supported by the Russian Science Foundation, grant number [23-45-10038]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright

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