PharmaMar presents new data on Zepzelca® (lurbinectedin) in combination with irinotecan at an oral session at (rescheduled) IASLC 2020

  • The Objective Response Rate (ORR) is 62% and a median Progression Free Survival (PFS) 6.2 months in second and third line patients with Small Cell Lung Cancer (SCLC).
  • Lurbinectedin's activity in combination with irinotecan is strong in sensitive patients (CTFI≥90) with an ORR of 69% and a median PFS of 8.1 months.
  • The activity is very encouraging in resistant patients (CTFI<90), with an ORR of 50% and a median PFS of 4.8 months.
  • Also noteworthy is the activity demonstrated by this combination in third-line patients, with an ORR of 38% and a median PFS of 4.2 months.
  • The combination has shown a well-tolerated and manageable safety profile.

Madrid, February 1st, 2021. - PharmaMar (MSE:PHM), along with Jazz Pharmaceuticals plc (Nasdaq: JAZZ), have announced today that new data for Zepzelca® (lurbinectedin) in combination with irinotecan have been presented at an oral session during the IASLC 2020 World Lung Cancer Conference, which has been held virtually from January 28th-31st.

Santiago Ponce, M.D., oncologist at the Hospital 12 de Octubre in Madrid, and one of the principal investigators of the study titled "EFFICACY AND SAFETY PROFILE OF LURBINECTEDIN-IRINOTECANIN PATIENTS WITH RELAPSED SCLC. Results from a Phase Ib-IItrial", highlighted that the combination of lurbinectedin with irinotecan proved to be effective in patients with Small Cell Lung Cancer (SCLC), after failure of first-line therapy, with particularly notable activity in patients with resistant disease (Chemotherapy-Free Interval CTFI <90 days) and also in 3rd line treatment.

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Data have been presented for a total of 21 evaluable patients with SCLC who had progressed after receiving at least one prior line of platinum-based chemotherapy. The Objective Response Rate (ORR) was 62%, with a median Progression Free Survival (PFS) of 6.2 months.

The activity of lurbinectedin in combination with irinotecan is particularly notable in sensitive patients (CTFI≥90) with an ORR of 69% and a median PFS of 8.1 months. Noteworthy is the activity demonstrated by this combination in third-line treatment, with an ORR of 38% and a median PFS of 4.2 months.

The activity is very encouraging in resistant patients (CTFI<90), with an ORR of 50% and a median PFS of 4.8 months.

The combination has shown a manageable safety profile, toxicities being mainly hematological abnormalities, fatigue and diarrhea, all of which were transient. There have been no deaths due to toxicity and no patients have discontinued treatment due to treatment-related toxicity.

It is planned to have a total of 47 patients in the cohort of this trial, and complete data will be presented at a future congress.

All studies presented at the reschedule IASLC 2020 Congress are available at: https://library.iaslc.org/conference-program?product_id=20

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This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About PharmaMar

Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: ZepzelcaTM (lurbinectedin, PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

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About lurbinectedin

Lurbinectedin (Zepzelca®), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.

Media Contact:

Alfonso Ortín - Communications Director aortin@pharmamar.comMobile: +34 609493127

Miguel Martínez-Cava - Communication Manager mmartinez-cava@pharmamar.comMobile: +34 606597464

Phone: +34 918466000

Capital Markets & Investor Relations:

José Luis Moreno- Capital Markets & Investor Relations Director María Marín de la Plaza - Capital Markets & Investor Relations investorrelations@pharmamar.com

Phone: +34 914444500

Or please visit our website at www.pharmamar.com

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Pharma Mar SA published this content on 01 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 February 2021 07:37:02 UTC.