Pepaxti included in European Guidelines for the treatment of multiple myeloma

Oncopeptides today announces that its drug Pepaxti has been included in new clinical practice guidelines from EHA-EMN* for patients with relapsed, refractory multiple myeloma. This marks an important recognition by leading experts of the drug’s clinical value and ability to meet an unmet medical need in the treatment of this serious blood cancer.

The guidelines are based on a thorough evaluation of clinical evidence by leading experts and aim to support doctors in selecting appropriate therapies for their patients. For patients who have received multiple prior lines of therapy and are triple-class refractory/exposed (TCR/TCE) – meaning their disease no longer responds to three major classes of myeloma drugs – Pepaxti is recommended based on Level 1 evidence, the strongest possible, and has a Grade B recommendation.

“The fact that Pepaxti has received a recommendation by this expert group once again confirms the drugs’ value in later lines of treatment and will support awareness of Pepaxti as a treatment option,” says Sofia Heigis, CEO at Oncopeptides. “We are happy to see Pepaxti having the highest combination of recommendation and clinical evidence of all non-CAR T therapies, supporting the use of Pepaxti as the first choice in subsequent treatment of multiple myeloma.”

Furthermore, Pepaxti has also been listed as a treatment option for patients with even more advanced disease, TCR/TCE patients relapsing after immunotherapy with either CAR-T cells or ADC and whose disease no longer responds to four drug classes.

“It is encouraging that Pepaxti is included as an option for even the most treatment-resistant patient population,” says Stefan Norin, Chief Medical Officer at Oncopeptides. “This reflects growing trust in the drug’s clinical performance in the pivotal studies and real-world settings.”

For Oncopeptides, this recognition is an important step toward broader use of Pepaxti in Europe and a strong signal of its potential to help patients with few remaining treatment options.

For more information, see the Q&A for investors below, where you will also find an episode of Oncopeptalks discussing this. The scientific article in Nature describing the EHA-EMN’s new guidelines can be found via this link.

* EHA-EMN refers to the collaboration between the European Hematology Association (EHA) and the European Myeloma Network (EMN). These organizations work together to advance research, clinical practice, and education in the field of hematology, with a particular focus on multiple myeloma.Investor Q&A: Inclusion of Pepaxti in EHA-EMN Clinical Guidelines

 

Questions and answers for investors

1. What does the inclusion of Pepaxti in the EHA-EMN guidelines mean for Oncopeptides?

   The recommendation by leading experts based on both clinical data and real-world experience is an important validation of Pepaxti’s value for patients, which is expected to support broader awareness and increase physician confidence in prescribing Pepaxti.

2. Which specific patient populations are recommended for treatment with Pepaxti according to the new guidelines?

   Pepaxti is recommended for patients with relapsed, refractory multiple myeloma who are triple-class refractory/exposed (TCR/TCE). It has been recommended for patients with even more advanced disease who have relapsed after immunotherapy with CAR-T cells or ADC.

3. What level of clinical evidence and recommendation grade has Pepaxti received in these guidelines?

   Pepaxti has received Level 1 evidence, the highest level, supported by a Grade B recommendation. The various recommendations are explained in the article EHA–EMN Evidence-Based Guidelines for diagnosis, treatment and follow-up of patients with multiple myeloma found here.

4. How does Pepaxti’s recommendation compare to other non-CAR T therapies?

   Pepaxti has the highest combination of recommendation strength and clinical evidence among all non-CAR T therapies, making it a first-choice option for subsequent treatment.

5. How might this guideline inclusion impact Pepaxti’s market penetration in Europe?

   This inclusion is anticipated to positively impact market penetration, potentially increasing adoption rates among European healthcare providers.

6. What are the next steps for Oncopeptides following this guideline recommendation?

   Oncopeptides will actively engage with key healthcare stakeholders to maximize awareness and utilization of Pepaxti across relevant European markets.

7. Are there any ongoing studies or additional clinical activities planned to further support Pepaxti’s clinical profile?

   Yes, Oncopeptides continues to generate real-world data which we expect will strengthen the case for Pepaxti as we receive positive feedback from doctors.

8. How significant is this guideline inclusion for the treatment landscape of relapsed/refractory multiple myeloma?

   This inclusion is significant as Pepaxti addresses an unmet need, especially in heavily pre-treated patients, and the recommendation by leading experts reinforces Pepaxti’s role as an essential option for challenging patient cases.

9. What potential revenue impact could this recommendation have for Oncopeptides?

   While we won´t comment in figures, the increased awareness following the recommendation in the EHA-EMN guidelines is expected positively affect our launch efforts in Europe as the recommendation supports both awareness and legitimacy of Pepaxti.

10. How does Oncopeptides plan to leverage this recommendation in its investor communication and strategic positioning?

    Oncopeptides will highlight this recommendation in investor dialogues, emphasizing Pepaxti’s strengthened clinical validation and strategic market opportunities in Europe.

 

Oncopeptalks on EHA-EMN Guideline Inclusion

Watch David and Sofia discuss the recent news. Available in Swedish with English subtitles (available through menu option below video).