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In the PD1+ era, how many combined immunization regimens have been approved?

 Last Update: 2022-04-27
 Source: Internet
 Author: User

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Since the introduction of PD1/PDL1 monoclonal antibody in 2014, after 8 years, immune checkpoint inhibitor therapy has completely reformed the thinking and framework of tumor treatment
.
With the three characteristics of "universality", "low toxicity" and "long-acting", it has become the cornerstone of major tumor treatment

However, I have to admit that the PD1/PDL1 monoclonal antibody can only bring therapeutic breakthroughs to patients in a very small area by its own single drug ability.
Therefore, in the development of immunity in recent years, the combination of immunity and other treatments is the main force.
In the direction, it has gradually developed from a single-drug immunization to a combined immunization army of Haohao Decoction, but do you know which cancers have been approved for combined use in immunization so far, and what kinds of drugs can be combined?

In which cancers have immunity been approved for combined use, and what kinds of drugs can be combined?

In order to solve the doubts, this article summarizes the current 10 kinds of PD1 mAbs or PDL1 mAbs in China that have been officially approved by the FDA or NMPA for immunocombination therapy indications, and feel the vastness of the PD1+ era!

PD1 mAb/PDL1 mAb combined with chemotherapy

Based on the standard status of chemotherapy in traditional tumor treatment, the addition of PD1/PDL1 monoclonal antibody has played an icing on the cake, and the combined treatment has achieved fruitful results
.

1.
1 Lung cancer

① K drug combined with pemetrexed/platinum in the treatment of EGFR/ALK negative advanced non-squamous non-small cell lung cancer

KEYNOTE189 study: K drug combined with pemetrexed/platinum in the treatment of advanced untreated non-squamous non-small cell lung cancer, the primary endpoint PFS was 8.
8 months: 4.
9 months, HR=0.
52
.

② K drug combined with TP chemotherapy in the treatment of EGFR/ALK negative advanced lung squamous cell carcinoma

KEYNOTE407 study: K drug combined with paclitaxel or nab-paclitaxel + carboplatin in the treatment of advanced untreated lung squamous cell carcinoma, the primary endpoint PFS was 6.
4 months: 4.
8 months, HR=0.
56
.

③ O-drug combined with platinum-containing doublet chemotherapy as neoadjuvant therapy for resectable non-small cell lung cancer (tumor ≥ 4 cm or lymph node positive)

CHECKMATE816 study: O drug combined with chemotherapy versus chemotherapy alone as neoadjuvant therapy for stage IB (≥4cm), II, and III resectable non-small cell lung cancer (3 cycles) 24.
0%: 2.
2%
.

④T drug combined with bevacizumab, paclitaxel and carboplatin in the treatment of advanced non-squamous non-small cell lung cancer without EGFR/ALK mutation

IMPOWER150 study: T drug combined with bevacizumab, paclitaxel and carboplatin versus bevacizumab + TP in the treatment of advanced non-squamous non-small cell lung cancer without EGFR/ALK mutation, the primary endpoint OS was 19.
2 months: 14.
7 months, respectively, HR=0.
78
.

⑤ T drug combined with bevacizumab, nab-paclitaxel and carboplatin as first-line treatment for advanced non-squamous non-small cell lung cancer without EGFR/ALK mutation

IMPOWER130 study: T drug combined with bevacizumab, nab-paclitaxel and carboplatin versus bevacizumab + TP in the treatment of advanced non-squamous non-small cell lung cancer without EGFR/ALK mutation, the primary endpoint OS was 18.
6 months: 13.
9 month, HR=0.
80
.

⑥Tislelizumab combined with paclitaxel and carboplatin in the treatment of advanced untreated lung squamous cell carcinoma

BGB-A317-307 study: Tislelizumab + TP versus TP chemotherapy in the treatment of advanced untreated lung squamous cell carcinoma, the primary endpoint PFS was 7.
6 months: 5.
5 months, HR=0.
52
.

⑦Camrelizumab combined with pemetrexed and carboplatin in the treatment of advanced and untreated EGFR/ALK-negative non-squamous non-small cell lung cancer

SHR-1210-III-303 study: camrelizumab combined with pemetrexed, carboplatin versus chemotherapy alone in the treatment of advanced naive EGFR/ALK-negative non-squamous non-small cell lung cancer, the primary endpoint of PFS was 11.
3 months, respectively : 8.
3 months, HR=0.
599
.

⑧ Sintilimab combined with pemetrexed and platinum in the treatment of advanced and untreated EGFR/ALK-negative non-squamous non-small cell lung cancer

ORIENT11 study: Sintilimab combined with pemetrexed, platinum versus chemotherapy alone in the treatment of advanced naive EGFR/ALK-negative non-squamous non-small cell lung cancer, the primary endpoint PFS was 8.
9 months: 5.
0 months, HR=0.
482
.

⑨ Sintilimab combined with gemcitabine and platinum in the treatment of advanced and untreated lung squamous cell carcinoma

ORIENT12 study: Sintilimab combined with gemcitabine and platinum versus chemotherapy alone in the treatment of advanced and untreated lung squamous cell carcinoma, the primary endpoint PFS was 5.
1 months: 4.
9 months, HR=0.
621
.

⑩T drug combined with carboplatin and etoposide in the treatment of newly diagnosed extensive-stage small cell lung cancer

IMPOWER133 study: T drug + EP regimen compared with EP chemotherapy in the treatment of untreated extensive-stage small cell lung cancer, the primary endpoint OS was 12.
3 months: 10.
3 months, HR=0.
73
.

⑪ I drug combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer

CASPIAN study: I drug + EP regimen compared with EP chemotherapy in the treatment of untreated extensive-stage small cell lung cancer, the primary endpoint OS was 13.
0 months: 10.
3 months, HR=0.
70
.

1.
2 Gastric cancer, gastroesophageal junction tumors and esophageal cancer

①O drug combined with standard chemotherapy in the treatment of advanced untreated gastric cancer, gastroesophageal junction tumor and esophageal adenocarcinoma

CHECKMATE649 study: O drug combined with chemotherapy in the treatment of advanced untreated gastric cancer, gastroesophageal junction tumor and esophageal adenocarcinoma, the primary endpoint OS was 13.
8 months: 11.
6 months, HR=0.
80
.

② K drug combined with fluorouracil and platinum-based chemotherapy for advanced esophageal cancer and gastroesophageal junction tumors that are not suitable for surgery and radical chemoradiotherapy

KEYNOTE590 study: K drug + fluorouracil/cisplatin versus fluorouracil/cisplatin in the treatment of advanced untreated esophageal cancer and gastroesophageal junction tumors, the primary endpoint OS was 12.
4 months: 9.
8 months, HR=0.
73
.

③ K drug combined with trastuzumab + chemotherapy containing fluorouracil and platinum in the treatment of HER2-positive advanced gastric cancer and gastroesophageal junction tumors

KEYNOTE811 study: K drug combined with trastuzumab + fluorouracil and platinum-containing chemotherapy versus trastuzumab + fluorouracil and platinum-containing chemotherapy in the treatment of HER2-positive advanced gastric cancer and gastroesophageal junction tumors, the primary endpoint ORR 74%: 52%
.

1.
3 Head and neck squamous cell carcinoma

K drug combined with FP chemotherapy in the treatment of advanced untreated head and neck squamous cell carcinoma

KEYNOTE048 study: K drug combined with FP regimen compared with cetuximab combined with FP regimen in the treatment of advanced untreated head and neck squamous cell carcinoma, the primary endpoint OS was 13.
0 months: 10.
7 months, HR=0.
77
.

1.
4 Cervical cancer

K drug combined with chemotherapy±bevacizumab in the treatment of advanced untreated cervical cancer with PDL1≥1%

KEYNOTE826 study: K drug combined with paclitaxel + cisplatin or carboplatin ± bevacizumab versus chemotherapy alone in the treatment of advanced untreated cervical cancer with PDL1 ≥ 1%, the primary endpoint PFS was 10.
4 months: 8.
2 months, HR=0.
62
.

1.
5 Triple-negative breast cancer

① K drug combined with chemotherapy as neoadjuvant therapy for high-risk early-stage triple-negative breast cancer

KEYNOTE522 study: K drug combined with chemotherapy versus chemotherapy as neoadjuvant therapy for early-stage high-risk triple-negative breast cancer, the primary endpoint pCR was 63.
0%: 55.
6%, respectively
.

② K drug combined with chemotherapy in the treatment of advanced untreated triple-negative breast cancer with advanced PDL1≥10%

KEYNOTE355 study: K drug combined with paclitaxel or nab-paclitaxel or gemcitabine + carboplatin versus chemotherapy alone in the treatment of advanced triple-negative breast cancer with PDL1 ≥ 10%, the primary endpoint PFS was 9.
7 months: 5.
6 months, HR=0.
65
.

1.
6 Nasopharyngeal carcinoma

①Camrelizumab combined with cisplatin and gemcitabine in the treatment of advanced and untreated nasopharyngeal carcinoma

SHR-1210-III-308 study: Camrelizumab combined with cisplatin and gemcitabine compared with chemotherapy alone in the treatment of advanced and untreated nasopharyngeal carcinoma, the primary endpoint PFS was 9.
7 months: 6.
9 months, HR=0.
54
.

②Toripalimab combined with cisplatin and gemcitabine in the treatment of advanced and untreated nasopharyngeal carcinoma

JUPITER-02 study: Toripalimab combined with cisplatin and gemcitabine versus chemotherapy alone in the treatment of advanced and untreated nasopharyngeal carcinoma, the primary endpoint PFS was 11.
7 months: 3.
7 months, HR=0.
52
.

Combined immunotherapy and chemotherapy are blooming everywhere, and there is a trend of early neoadjuvant and adjuvant development.
However, it should be noted that the combination of chemotherapy and immunity has not been successful in all cancers.
There have been failed studies.
There is no lack of population restriction on the expression of PDL1 in the disease, which should be paid attention to in clinical application
.

PD1 mAb/PDL1 mAb combined with other immunizations

Whether the combination of double immunity can let us go to chemotherapy treatment seems to be feasible in some cancers at present, but we need to answer a question, which is better in terms of efficacy and safety compared with chemotherapy
.

O drug combined with CTLA4 monoclonal antibody ipilimumab (ipilimumab, referred to as Y drug)

(1) Lung cancer

① O drug combined with Y drug in the treatment of advanced untreated non-small cell lung cancer patients with EGFR/ALK mutation-negative PDL1 ≥ 1%

CHECKMATE227 study: O drug + Y drug compared with standard chemotherapy in patients with advanced non-small cell lung cancer with PDL1 ≥ 1%, the primary endpoint OS was 17.
1 months: 14.
9 months, HR=0.
79
.

② O drug combined with Y drug + 2 cycles of platinum-containing chemotherapy in the treatment of EGFR/ALK mutation-negative advanced non-small cell lung cancer patients

CHECKMATE9LA study : O drug + Y drug + 2 cycles of chemotherapy compared with standard chemotherapy in patients with advanced non-small cell lung cancer, the primary endpoint OS was 14.
1 months: 10.
7 months, HR=0.
69
.

(2) Melanoma

O drug combined with Y drug in the treatment of advanced untreated melanoma

CHECKMATE067 study: O drug + Y drug versus O drug in the treatment of advanced untreated melanoma, the primary endpoint of PFS was 11.
5 months: 6.
9 months, respectively
.

(3) Malignant pleural mesothelioma

O drug combined with Y drug in the treatment of advanced untreated malignant pleural mesothelioma

CHECKMATE743 study: O drug + Y drug versus standard chemotherapy in the treatment of advanced untreated pleural mesothelioma, the primary endpoint OS was 18.
1 months: 14.
1 months, HR=0.
74
.

(4) Kidney cancer

Drug O combined with Drug Y in the treatment of intermediate and high-risk advanced renal cell carcinoma

CHECKMATE214 study: O drug + Y drug versus sorafenib in the treatment of advanced untreated renal cell renal cell carcinoma, the primary endpoint OS were NR: 25.
9 months, HR=0.
63; PFS were 11.
6 months: 8.
4 months, HR=0.
82
.

(5) Liver cancer

① Drug O combined with drug Y in the treatment of advanced liver cancer that has progressed on previous sorafenib therapy

CHECKMATE040 study: O drug + Y drug in the treatment of advanced liver cancer patients with previous sorafenib resistance, the primary endpoint ORR was 33%
.

(6) MSI-H/dMMR colorectal cancer

① Drug O combined with drug Y for advanced colorectal cancer with MSI-H/dMMR who failed standard chemotherapy

CHECKMATE142 study: O drug + Y drug in the treatment of MSI-H/dMMR advanced colorectal cancer who failed previous treatment, ORR was 60%
.

O drug combined with LAG3 monoclonal antibody Relatinib (Relatlimab, referred to as R drug) in the treatment of newly treated advanced melanoma

RELATIVITY-047 study: R-drug + O-drug versus O-drug alone in the first-line treatment of advanced and untreated melanoma patients, PFS was 10.
1 months: 4.
6 months, respectively
.

The combination of double immunity allows clinical patients to gradually get rid of chemotherapy, but has not obtained indications in extensive cancer
.
And in some cancers, such as lung cancer, the early curative effect is insufficient, and short-term chemotherapy is needed to help.

This is the shortcoming of the current double immunity

PD1 mAb/PDL1 mAb combined with targeted drugs

Target-free has proved its advantages in some traditional cancers treated with targeted therapy as the standard treatment, and also brought considerable safety
.
Cancer limitation is a major scaling problem for this type of program

(1) Combined with multi-target drugs

① O drug combined with cabozantinib in the treatment of advanced and newly treated renal cell renal cell carcinoma

CHECMATE9ER study: O drug combined with cabozantinib versus sorafenib in the treatment of advanced untreated renal cell renal cancer, the primary end point PFS was 16.
6 months: 8.
3 months, HR=0.
51
.

② K drug combined with axitinib in the treatment of advanced untreated renal cell renal cell carcinoma

KEYNOTE426 study: K drug combined with axitinib versus sorafenib in the treatment of advanced untreated renal cell renal cell carcinoma, the primary endpoint PFS was 15.
1 months: 11.
0 months, HR=0.
69
.

③ K drug combined with lenvatinib in the treatment of advanced untreated renal cell renal cell carcinoma

KEYNOTE581 study: K drug combined with lenvatinib versus sorafenib in the treatment of advanced untreated renal cell renal cancer, the primary endpoint PFS was 23.
9 months: 9.
2 months, HR=0.
39
.

④ Drug K combined with lenvatinib in the treatment of non-MSI-H/dMMR advanced endometrial cancer that has progressed on previous systemic therapy

The KEYNOTE775 study: K drug combined with lenvatinib compared with second-line standard chemotherapy in the treatment of non-MSI-H/dMMR advanced endometrial cancer with progression on previous treatment.
The primary endpoint OS was 17.
4 months: 12.
0 months, HR=0.
68
.

(2) Combined with single target drug

① T drug combined with bevacizumab in the first-line treatment of patients with advanced hepatocellular carcinoma

IMPOWER150 study: T drug + bevacizumab versus sorafenib in the treatment of advanced untreated hepatocellular carcinoma, the primary endpoint PFS was 6.
8 months: 4.
3 months, HR=0.
59
.

② Sintilimab combined with bevacizumab for advanced untreated hepatocellular carcinoma

ORIENT32 study: Sintilimab combined with bevacizumab versus sorafenib in the treatment of advanced untreated hepatocellular carcinoma, the primary endpoint of PFS was 4.
6 months: 2.
8 months, HR=0.
565
.

③T drug combined with cobitinib and vemurafenib in the treatment of advanced untreated melanoma with BRAFv600 mutation

IMSPIRE150 study: T drug + combined with cobitinib, vemurafenib versus cobitinib + vemurafenib in the first-line treatment of BRAFv600-mutated advanced untreated melanoma, the primary endpoint PFS was 15.
1 months: 10.
6 months, HR=0.
78
.

The success of target-free combination is more focused on liver cancer and kidney cancer, which are good at multi-target drugs (anti-vascular drugs)
.
Although the indications are limited, it can be used more in the back-line treatment of various types of cancer, which can often bring unexpected joy

References:

References: References:

8.
https://drugs.
medlive.
cn/drugref/html/21697.
shtml

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