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Table 2 List of investigated products

From: Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial

#

Product

FDA Approved Date

Indication

ORR

BCT

ORR of BCT

Reference of BCT

1

Crizotinib

(Xalkori)

March 11, 2016

Metastatic NSCLC whose tumors are ROS1-positive

66.0%

Paclitaxel + Carboplatin + 

Bevacizumab

35%

Sandler et al.[9]

2

Atezolizumab

(Tecentriq)

May 18, 2016

Locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

14.8%

Vinflunine

9%

Drugs@FDA [10]

3

Pembrolizumab

(Keytruda)

August 5, 2016

Recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy

16.0%

Cetuximab

13%

Vermorken et al. [11]

4

Rucaparib

(Rubraca)

December 19, 2016

Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies

54.0%

Olaparib

34%

Drugs@FDA [12]

5

Nivolumab

(Opdivo)

February 2, 2017

Locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy

19.6%

Atezolizumab

14.8%

See the result of #2

6

Avelumab

(Bavencio)

March 23, 2017

Metastatic MCC

33.0%

NA

  

7

Brigatinib

(Alunbrig)

April 28, 2017

Metastatic ALK-positive NSCLC who have progressed on or are intolerant to crizotinib

53.6%

Alectinib

44%

Drugs@FDA [13]

8

Durvalumab

(Imfinzi)

May 1, 2017

Locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

17.0%

Nivolumab

19.6%

See the result of #5

9

Avelumab

(Bavencio)

May 9, 2017

Locally advanced or metastatic UC whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy

16.1%

Nivolumab

19.6%

See the result of #5

10

Pembrolizumab

(Keytruda)

May 18, 2017

Locally advanced or metastatic UC who are not eligible for cisplatin-containing chemotherapy

28.6%

Carboplatin + Gemcitabine

36.1%

Santis et al. [14]

11

Dabrafenib and Trametinib

(Tafinlar and Mekinist)

June 22, 2017

Metastatic NSCLC with BRAF V600E mutation

61.0%

Paclitaxel + Carboplatin + 

Bevacizumab

35%

Sandler et al. [9]

12

Nivolumab

(Opdivo)

July 31, 2017

dMMR and MSI-H metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

28.0%

TAS-102

1.6%

Mayer et al. [15]

13

Pembrolizumab

(Keytruda)

September 22, 2017

Recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy

13.3%

NA

  

14

Nivolumab

(Opdivo)

September 22, 2017

HCC in patients who have been previously treated with sorafenib

14.3%

Regorafenib

11%

Bruix et al. [16]

15

Abemaciclib

(Verzenio)

September 28, 2017

Monotherapy for women and men with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

19.7%

Eribulin

11.0%

Drugs@FDA [17]

16

Afatinib

(Gilotrif)

January 12, 2018

Broadened indication in first-line treatment of patients with metastatic NSCLC whose tumors have non-resistant EGFR mutations

66.0%

Afatinib

50.4%

FDA Drug Approvals and Databases [18]

17

Dabrafenib and Trametinib

(Tafinlar and Mekinist)

May 4, 2018

Locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and with no satisfactory locoregional treatment options

61.0%

Paclitaxel + Carboplatin

16%

Sosa et al. [19]

18

Pembrolizumab

(Keytruda)

June 1, 2018

Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥ 1)

14.3%

Nab-paclitaxel

28.6%

Alberts et al. [20]

19

Ipilimumab

(Yervoy)

July 10, 2018

Combination with nivolumab, MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

46.0%

Nivolumab

28%

See the result of #12

20

Nivolumab

(Opdivo)

August 16, 2018

Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy

12.0%

NA

  

21

Cemiplimab-rwlc

(Libtayo)

September 28, 2018

Metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation

47.0%

Panitumumab

31%

Drugs@FDA [21]

22

Lorlatinib

(Lorbrena)

November 2, 2018

ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease

48.0%

Atezolizumab

14%

Drugs@FDA [22]

23

Pembrolizumab

(Keytruda)

November 9, 2018

HCC who have been previously treated with sorafenib

17.0%

Nivolumab

14.3%

See the result of #14

24

Pembrolizumab

(Keytruda)

December 19, 2018

Recurrent locally advanced or metastatic MCC

56.0%

Avelumab

33.0%

See the result of #6

25

Erdafitinib

(Balversa)

April 12, 2019

Locally advanced or metastatic UC, that has:

• susceptible FGFR3 or FGFR2 genetic alterations, and

• progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy

32.2%

Pembrolizumab

21.0%

Drugs@FDA [23]

26

Pembrolizumab

(Keytruda)

June 17, 2019

Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy

19.0%

Nivolumab

12.0%

See the result of #20

27

Entrectinib

(Rozlytrek)

August 15, 2019

Metastatic NSCLC whose tumors are ROS1-positive

78.0%

Crizotinib

66.0%

Drugs@FDA [24]

28

Pembrolizumab plus Lenvatinib

(Keytruda plus Lenvima)

September 17, 2019

Advanced endometrial carcinoma that is not MSI-H or dMMR and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation

38.3%

Bevacizumab

13.5%

Aghajanian et al. [25]

29

Niraparib

(Zejula)

October 23, 2019

Advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with HDR-positive status

24.0%

Olaparib

34.0%

Kim et al. [26]

30

Enfortumab vedotin-ejfv

(Padcev)

December 18, 2019

Adult patients with locally advanced or metastatic UC who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting

44.0%

Docetaxel

10.5%

Drakaki et al. [27]

31

Fam-trastuzumab deruxtecan-nxki

(Enhertu)

December 20, 2019

Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting

60.3%

T-DM1

31.0%

Krop et al. [28]

  1. ALK anaplastic lymphoma kinase, BRAF v-RAF murine sarcoma viral oncogene homolog B1, BRCA breast cancer susceptibility gene, CPS combined positive score, CSCC cutaneous squamous cell carcinoma, dMMR mismatch-repair deficient, EGFR epidermal growth factor receptor, FGFR fibroblast growth factor receptor, HCC Hepatocellular carcinoma, HDR homologous recombination deficiency, HER2 human epidermal growth factor receptor, HR hormone receptor, MCC merkel cell carcinoma, MSI-H microsatellite instability-high, NA not applicable, NSCLC non-small cell lung cancer, PD-1 programmed cell death receptor-1, PD-L1 programmed cell death ligand 1, ROS1 c-ros oncogene 1, SCLC small cell lung cancer, UC urothelial carcinoma