# US 2026/0076964 A1 · Method of treating sclc and managing hepatotoxicity

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- Number: US 2026/0076964 A1
- Document ID: US20260076964A1
- Status: Published application
- Kind: A1
- Application number: 19/336,350
- Filed: 2025-09-22
- Published: 2026-03-19
- Earliest claimed: 2019-11-21
- Assignees: Pharma Mar, S.A.
- Applicants: Pharma Mar, S.A.
- Inventors: Carmen Kahatt; José Maria Fernandez; Salvador Fudio; Arturo Soto; Pilar Lardelli; Cristian Fernandez
- Web page: https://patentgrep.com/patent/US20260076964A1

## CPC

- A61K 31/4995: Pyrazines or piperazines forming part of bridged ring systems
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 31/4738: ortho- or peri-condensed with heterocyclic ring systems
- A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48)
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 38/193: {Colony stimulating factors [CSF]}
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 35/00: Antineoplastic agents
- C07D 519/00: Heterocyclic compounds containing more than one system of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring system not provided for in groups C07D453/00 or C07D455/00
- C07B 2200/13: Crystalline forms, e.g. polymorphs
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)
- C07B: GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR (preparation of carboxylic acid esters by telomerisation C07C67/47; telomerisation C08F)

## Abstract

Provided are methods for the treatment of SCLC patients by administering therapeutic amounts of lurbinectedin by intravenous infusion. Also provided are methods of treating cancer by administering lurbinectedin in combination with other anticancer drugs, in particular topoisomerase inhibitors. The invention further relates to the administration of lurbinectedin in combination with anti-emetic agents for effective control of symptoms related to nausea and vomiting, reduced lurbinectedin dosages to achieve a safer administration and an increase in the number of treatment cycles. Stable lyophilized formulations of lurbinectedin are also provided.

## Claims

### Claim 1

A method of treating metastatic small cell lung cancer (SCLC) in a patient after platinum-based chemotherapy, said method comprising administering, within 35 days of receiving a treatment cycle comprising a dose of 3.2 mg/m2 of lurbinectedin by intravenous infusion as sole chemotherapy agent, a subsequent treatment cycle comprising a dose of 2.6 mg/m2 lurbinectedin by intravenous infusion as sole chemotherapy agent to the patient having at the time of the administration of the dose of 2.6 mg/m2 of lurbinectedin:
a) metastatic SCLC,
b) a platelet count of at least 100,000/mm3,
c) an absolute neutrophil count of at least 1500 cells/mm3, and
d) ≤Grade 1 hepatotoxicity;
wherein the patient previously experienced ≥Grade 3 hepatotoxicity subsequent to receiving the dose of 3.2 mg/m2 of lurbinectedin; and
wherein one dose of lurbinectedin is administered per treatment cycle, and wherein each of the treatment cycles are 21 to 35 days.

### Claim 2 (depends on 1)

The method according to claim 1, wherein each of the treatment cycles are 21 days.

### Claim 3 (depends on 1)

The method according to claim 1 further comprising:
administering, within 35 days of receiving a treatment cycle comprising a dose of 2.6 mg/m2 of lurbinectedin by intravenous infusion as sole chemotherapy agent, a treatment cycle comprising a dose of 2.0 mg/m2 lurbinectedin by intravenous infusion as sole chemotherapy agent to the patient having at the time of the administration of the dose of 2.0 mg/m2 of lurbinectedin:
(a) a platelet count of at least 100,000/mm3,
(b) an absolute neutrophil count of at least 1500 cells/mm3, and
(c) ≤Grade 1 hepatotoxicity;
wherein the patient previously experienced ≥Grade 3 hepatotoxicity subsequent to receiving the dose of 2.6 mg/m2 of lurbinectedin.

### Claim 4 (depends on 3)

The method according to claim 3, wherein each of the treatment cycles are 21 days.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the platinum-based chemotherapy is carboplatin or cisplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 6 (depends on 2)

The method according to claim 2, wherein the platinum-based chemotherapy is carboplatin or cisplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the platinum-based chemotherapy is carboplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 8 (depends on 2)

The method according to claim 2, wherein the platinum-based chemotherapy is carboplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 9 (depends on 7)

The method according to claim 7, wherein the immunotherapy is atezolizumab.

### Claim 10 (depends on 8)

The method according to claim 8, wherein the immunotherapy is atezolizumab.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 12 (depends on 2)

The method according to claim 2, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 13 (depends on 5)

The method according to claim 5, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 14 (depends on 9)

The method according to claim 9, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 15 (depends on 10)

The method according to claim 10, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 16

A method of treating metastatic small cell lung cancer (SCLC) in a patient after platinum-based chemotherapy, said method comprising:
(a) administering a treatment cycle comprising a dose of 3.2 mg/m2 of lurbinectedin by intravenous infusion as sole chemotherapy agent to the patient having, at the time of the administration of the dose of 3.2 mg/m2 of lurbinectedin:
(i) metastatic SCLC,
(ii) an absolute neutrophil count of at least 1500 cells/mm3,
(iii) a platelet count of at least 100,000/mm3, and
(iv) ≤Grade 1 hepatotoxicity;
wherein the patient experienced ≥Grade 3 hepatotoxicity subsequent to the administration of the dose of 3.2 mg/m2 of lurbinectedin and returns within 35 days of the administration of the dose of 3.2 mg/m2 of lurbinectedin to ≤Grade 1 hepatotoxicity after experiencing the ≥Grade 3 hepatotoxicity; and
(b) administering by intravenous infusion as sole chemotherapy agent a treatment cycle comprising a dose of 2.6 mg/m2 of lurbinectedin to the patient after the patient returns to ≤Grade 1 hepatotoxicity and has a platelet count of at least 100,000/mm3 and an absolute neutrophil count of at least 1500 cells/mm3; and
wherein one dose of lurbinectedin is administered per treatment cycle, and wherein each of the treatment cycles are 21 to 35 days.

### Claim 17 (depends on 16)

The method according to claim 16, wherein each of the treatment cycles are 21 days.

### Claim 18 (depends on 16)

The method according to claim 16 further comprising:
administering, within 35 days of receiving a dose of 2.6 mg/m2 of lurbinectedin by intravenous infusion as sole chemotherapy agent, a treatment cycle comprising a dose of 2.0 mg/m2 lurbinectedin by intravenous infusion as sole chemotherapy agent to the patient having at the time of the administration of the dose of 2.0 mg/m2 of lurbinectedin:
(a) a platelet count of at least 100,000/mm3,
(b) an absolute neutrophil count of at least 1500 cells/mm3, and
(c) ≤Grade 1 hepatotoxicity;
wherein the patient previously experienced >Grade 3 hepatotoxicity subsequent to receiving the dose of 2.6 mg/m2 of lurbinectedin.

### Claim 19 (depends on 18)

The method according to claim 18, wherein each of the treatment cycles are 21 days.

### Claim 20 (depends on 16)

The method according to claim 16, wherein the platinum-based chemotherapy is carboplatin or cisplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 21 (depends on 17)

The method according to claim 17, wherein the platinum-based chemotherapy is carboplatin or cisplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 22 (depends on 16)

The method according to claim 16, wherein the platinum-based chemotherapy is carboplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 23 (depends on 17)

The method according to claim 17, wherein the platinum-based chemotherapy is carboplatin and etoposide; and the platinum-based chemotherapy is given in combination with immunotherapy.

### Claim 24 (depends on 22)

The method according to claim 22, wherein the immunotherapy is atezolizumab.

### Claim 25 (depends on 23)

The method according to claim 23, wherein the immunotherapy is atezolizumab.

### Claim 26 (depends on 16)

The method according to claim 16, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 27 (depends on 17)

The method according to claim 17, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 28 (depends on 20)

The method according to claim 20, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 29 (depends on 24)

The method according to claim 24, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).

### Claim 30 (depends on 25)

The method according to claim 25, wherein the metastatic SCLC is extensive stage SCLC (ES-SCLC).